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Clinical Trials

Clinical Trials2019-04-08T09:22:19+00:00

ANG1005 in Breast Cancer Patients With Recurrent Brain Metastases

This is a Phase 2 study to see if an investigational drug, ANG1005, can shrink tumor cells in
breast cancer patients with recurrent brain metastases.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. ≥ 18 years old

2. Breast cancer

3. Recurrent brain metastases from breast cancer

4. At least one radiologically-confirmed and measurable metastatic brain lesion ( ≥ 0.5
cm)

5. Neurologically stable

6. Karnofsky Performance Status (KPS) score ≥ 70

Exclusion Criteria:

1. Prior treatment with ANG1005/GRN1005

2. Pregnancy or lactation

3. Inadequate bone marrow reserve

4. Any evidence of severe or uncontrolled diseases

5. Patients with the presence of an infection including abscess or fistulae, or known
infection with hepatitis B or C or HIV

6. CNS disease requiring immediate neurosurgery intervention (e.g., resection, shunt
placement, etc.)

7. Known allergy to paclitaxel or any of its components

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

The purpose of this research study is to find out whether adding an experimental vaccine
called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve
progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII
positive glioblastoma.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

Among other criteria, patients must meet the following conditions to be eligible for the
study:

1. Age ≥18 years of age.

2. Histologic diagnosis of glioblastoma (WHO Grade IV).

3. Documented EGFRvlll positive tumor status (central lab confirmation).

4. First or second relapse of de novo glioblastoma or first diagnosis or first relapse of
secondary glioblastoma.

5. Previous treatment must include surgery, conventional radiation therapy and
temozolomide (TMZ).

6. Screening MRI must be obtained at least 4 weeks after any salvage surgery, and at
least 12 weeks after radiation therapy.

7. KPS of ≥ 70%.

8. If applicable, systemic corticosteroid therapy must be at a dose of ≤ 4 mg of
dexamethasone or equivalent per day during the week prior to Day 1.

9. Evaluable disease in Groups 1 and 2; measurable disease in Group 2C

10. Life expectancy > 12 weeks.

11. Patients in Group 2 and 2C must have had disease progression while receiving
bevacizumab or within 2 months of treatment with bevacizumab.

Exclusion Criteria:

Among other criteria, patients who meet the following conditions are NOT eligible for the
study:

1. Subjects unable to undergo an MRI with contrast.

2. History, presence, or suspicion of metastatic disease

3. Prior receipt of vaccination against EGFRvIII.

4. Any known contraindications to receipt of study drugs, including known allergy or
hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®),
polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to
shellfish proteins.

5. Use of non-protein based investigational therapy within 14 days prior to Day 1 or use
of antibody-based investigational therapy within 28 days prior to Day 1.

6. Clinically significant increased intracranial pressure (e.g., impending herniation),
uncontrolled seizures, or requirement for immediate palliative treatment

7. Evidence of recent hemorrhage on screening MRI of the brain

8. Evidence of current drug or alcohol abuse.

9. Patients in Group 1 must not have received prior treatment with bevacizumab.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Post-approval Study of NovoTTF-100A in Recurrent GBM Patients

This is a non-randomized, concurrent control study, designed to confirm that the efficacy of
the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings
following approval is comparable to that of BSC chemotherapy patients. The device is a
portable, battery operated device that was approved for the treatment of adult patients (22
years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following
histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the
brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and
is intended as an alternative to standard medical therapy for GBM after surgical and
radiation options have been exhausted.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. 22 years of age or older

2. Histological diagnosis of GBM (WHO grade IV)

3. Tumor located in the supra-tentorial region of the brain

4. Received maximal, safe, surgical resection

5. Received maximal radiation therapy

6. Received concomitant Temozolomide

7. Received maintenance Temozolomide

8. First recurrence (based on radiological or histological evidence of recurrence)

9. Karnofsky performance score 70 or above

10. MMSE score 25 or above

11. Adequate amount and quality of tumor tissue from first surgical resection available
for genetic profiling

12. Women of childbearing age must be on effective contraception

13. Signed informed consent

14. Stable steroid dose in past 4 weeks

Exclusion Criteria:

1. Implanted electronic medical device in the brain:

1. Deep brain stimulator

2. Vagus nerve stimulator

3. Programmable shunt

2. Skull defect without replacement

3. Unable to comply with treatment with the NovoTTF-100A device

4. Pregnant

5. Prior antiangiogenic therapy (e.g., Bevacizumab/Avastin)

6. Second or subsequent recurrence

7. Any prior cytotoxic chemotherapy except Temozolomide

8. Actively participating in another therapeutic clinical trial

9. Radiological suspicion of pseudoprogression or radionecrosis

10. Radiation therapy or surgery in the past 4 weeks

11. Unable to comply with the study follow-up schedule

12. Any serious co-morbidity which is expected to affect survival more adversely than GBM

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Safety and Efficacy of Trans Sodium Crocetinate (TSC) With Radiation and Temozolomide in Newly Diagnosed Glioblastoma

This open-label study evaluated the safety and efficacy of TSC when dosed concomitantly with
the standard of care (radiation therapy and temozolomide) for newly diagnosed glioblastoma in
adults. All patients received TSC in the study. The objective of the study was to evaluate
the effect of TSC on survival and tumor response in patients with GBM while establishing an
acceptable patient risk profile.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Aged at least 18 years of age; male or female. A patient who is 70 years of age or
older may be considered for enrollment after review of patient clinical and laboratory
data by the Protocol Medical Monitor.

– Histologically confirmed diagnosis of GBM.

– Contrast enhancing disease on MRI within 21 days prior to screening.

– Karnofsky score (KPS) of ≥ 60 at Screening.

– No prior RT, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a
biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.

– Within 2 weeks of baseline visit, hematologic and renal functions as specified:
Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.0g/dL,
creatinine ≤ 1.7mg/dl, total bilirubin ≤ 1.5mg/dL, blood urea nitrogen (BUN) within 2
times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the
institutional norm.

– Sexually active patients must use an acceptable method of contraception while
receiving doses of study medication.

– Females of childbearing potential must have a negative serum or urine pregnancy test
at screening and have additional pregnancy tests during study.

Exclusion Criteria:

– Patient who cannot undergo MRI.

– Pregnant or lactating.

– Serious concurrent infection or medical illness that would jeopardize the ability of
the patient to receive study treatment with reasonable safety.

– Patient receiving concurrent chemotherapeutics or investigational agents within 30
days of baseline assessments, including gliadel wafers or gliasite application.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Assessing the Patient Experience in Cancer Care

Communication is an important component of comprehensive cancer care impacting patient
satisfaction, adherence, and quality of life. The wide array of issues addressed in cancer
clinical interactions makes communicating about a broad range of topics (including quality of
life, communication, symptom control, complementary/alternative therapies, costs, treatment
burden, prognosis, anxiety, side-effects, sexual function, palliative care options, etc.)
especially interesting and potentially challenging. Some of these topics may not be routinely
addressed in the clinical interaction or may require consultative support from other members
of the comprehensive cancer care team. One frequently overlooked critical element in research
on communication between cancer clinicians, their patients, and their primary care clinicians
is describing real-time consultations between patients and their clinicians. These
interactions provide rich material for assessing key psycho-social dynamics and identifying
issues that patients find important in their care. In order to devise systems of care that
optimize the patient experience, it is critical that clinicians and researchers understand,
appreciate, and systematically characterize the richness and complexity of the
decision-making process in routine cancer consultations between cancer patients and their
treating clinicians. This study seeks to assess the patient experience in cancer care by
observing patients and their physicians in their clinical interactions and following them for
several months to see how their care went. By describing in-depth the conversations and
experiences of patients in these clinical interactions, this study will lay the foundation
for practice-based interventions to optimize patients’ interactions with their cancer care
teams.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Age greater than or equal to 18 years

– Histological confirmation of: brain, breast, endocrine, gastrointestinal,
genitourinary, gynecological, head/neck, lung, melanoma, or sarcoma malignancies.

– Speak English or Spanish

– Not enrolled in hospice

– In any of the following phases of the cancer control continuum: initial diagnosis,
initial treatment, early survivorship, or recurrence.

– Provide written informed consent

Exclusion Criteria:

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Bevacizumab With or Without Trebananib in Treating Patients With Recurrent Brain Tumors

This partially randomized phase II trial with a safety run-in component studies the side
effects and how well bevacizumab given with or without trebananib works in treating patients
with brain tumors that have come back (recurrent). Immunotherapy with monoclonal antibodies,
such as bevacizumab, may induce changes in the body’s immune system and interfere with the
ability of tumor cells to grow and spread. Trebananib may stop the growth of tumor cells by
blocking blood flow to the tumor. It is not yet known whether giving bevacizumab together
with trebananib is more effective than bevacizumab alone in treating brain tumors.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Histologically proven diagnosis of glioblastoma or variants (gliosarcoma, glioblastoma
with oligodendroglial features, giant cell glioblastoma); patients will be eligible if
the original histology was a lower grade glioma and a subsequent histological
diagnosis of glioblastoma or variants is made

– The tumor must be supratentorial; patients with infratentorial disease, spinal cord
disease, and/or leptomeningeal disease are excluded

– Patients must have shown unequivocal evidence for tumor progression on the previous
treatment regimen (prior to enrollment on this study) by magnetic resonance imaging
(MRI) scan of the brain with and without contrast within 14 days prior to
registration; the dose of steroids must be stable or decreasing for at least 5 days
prior to the scan; patients with tumor progression who then undergo surgical resection
prior to enrollment on study may be eligible as long as pathology confirms progressive
or recurrent glioblastoma multiforme (GBM) (or variants); for patients who undergo
surgical resection, registration on study may not occur any sooner than 28 days from
surgery; an MRI scan of the brain with and without contrast is still required within
14 days prior to registration on study but is not required to demonstrate measurable
disease or tumor progression after surgery

– Patients unable to undergo MRI because of non-compatible devices can be enrolled,
provided computed tomography (CT) scans are obtained and are of sufficient quality;
patients without non-compatible devices may not have CT scans performed to meet this
requirement

– History/physical examination within 14 days prior to registration

– Karnofsky performance scale >= 70 within 14 days prior to registration

– Patients who have received prior treatment with interstitial brachytherapy,
stereotactic radiosurgery, or implanted chemotherapy sources, such as wafers of
polifeprosan 20 with carmustine, must have confirmation of progressive disease within
14 days prior to registration based upon nuclear imaging, magnetic resonance (MR)
spectroscopy, perfusion imaging, or histopathology

– Leukocytes > 3,000/mm^3 (within 14 days prior to registration)

– Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 14 days prior to
registration)

– Hemoglobin >= 10.0 g/dL (note: the use of transfusion or other intervention to achieve
hemoglobin [Hgb] >= 10.0 g/dL is acceptable) (within 14 days prior to registration)

– Platelets >= 100,000 cells/mm^3 (within 14 days prior to registration)

– Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
< 2.5 X institutional upper limit of normal (within 14 days prior to registration) - Bilirubin =< 2.0 mg/dL (within 14 days prior to registration) - Creatinine within normal upper institutional limits or creatinine clearance > 60
mL/min/1.73 m^2 (per 24 hour urine collection or calculated according to the
Cockcroft-Gault formula) for subjects with creatinine levels above the institutional
normal (within 14 days prior to registration)

– Patients with creatinine levels below normal institutional limits are eligible

– Prothrombin time (PT)/international normalized ratio (INR) =< 1.5 (within 14 days prior to registration) - Urinary protein =< 30 mg/dL in urinalysis or =< 1+ on dipstick (within 14 days prior to registration) - Generally well-controlled blood pressure with systolic blood pressure =< 140 mm Hg AND diastolic blood pressure =< 90 mm Hg within 5 days prior to registration; the use of anti-hypertensive medications to control hypertension is permitted - Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (HCG) pregnancy test within 14 days prior to registration - Women of childbearing potential and male patients who are sexually active must practice adequate contraception during therapy and for 180 days (6 months) afterwards - Patient must provide study specific informed consent prior to study entry Exclusion Criteria: - Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) - Prior systemic cytotoxic chemotherapy within (i.e., =<) 28 days (42 days for nitrosoureas or mitomycin C) prior to registration, or patients who have not returned to baseline or =< Common Terminology Criteria for Adverse Events (CTCAE) version 4 (v. 4) grade 2 from adverse events (excluding alopecia) due to agents administered more than 28 days prior to registration - Patients who received non-cytotoxic drug therapy must be off treatment for at least 14 days prior to registration; prior treatment with anti-vascular endothelial growth factor (VEGF) targeted agents; AMG 386 therapy; or other molecules that inhibit angiopoietins or TEK tyrosine kinase, endothelial (Tie2) receptor including, but not limited to, XL-820, XL-184 (cabozantinib-s-malate), and CVX-060/PF-4856884 is not allowed regardless of time frame - Patients who have not yet completed at least 21 days (30 days for prior monoclonal antibody therapy) since ending other investigational device or drug trials, or who are currently receiving other investigational treatments - Treatment within 30 days prior to enrollment with strong immune modulators, including but not limited to systemic cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, methotrexate, azathioprine, rapamycin, thalidomide, lenalidomide, and targeted immune modulators such as abatacept (CTLA-4-Ig), adalimumab, alefacept, anakinra, belatacept (LEA29Y), efalizumab, etanercept, infliximab, or rituximab - Prior radiotherapy within 90 days (3 months) prior to registration unless there is either: a) histopathologic confirmation of recurrent tumor; or b) new enhancement on MRI outside of the radiation treatment field - Major surgical procedure (including craniotomy and open brain biopsy) or significant traumatic injury within 28 days prior to registration or those patients who receive a non-central nervous system (CNS) minor surgical procedures (e.g. core biopsy or fine needle aspiration) within 3 days prior to registration; there is no waiting period for central line placement; there is a 7-day window for recovery prior to registration for patients who underwent stereotactic biopsy of the brain - Prior therapy with anti-VEGF targeted agents (e.g. bevacizumab, cediranib, vandetanib, aflibercept, sunitinib, sorafenib, etc.); prior therapy with thalidomide and lenalidomide is allowed as long as treatment has not occurred within 30 days prior to enrollment - More than 2 relapses - Therapeutic anticoagulation with warfarin < 7 days prior to registration; (therapeutic or prophylactic therapy with aspirin, a low-molecular weight heparin, or a Factor Xa inhibitor is acceptable) - Intratumoral hemorrhage or peritumoral hemorrhage, demonstrated by MRI or CT scan, CTCAE, v. 4 grade 2 or greater or evidence of significant hemorrhage (regardless of CTCAE, v. 4 grade) defined as > 1 cm diameter of blood (including postoperative
hemorrhage)

– Gastrointestinal bleeding or any other hemorrhage/bleeding event CTCAE, v. 4 grade 3
or greater within 30 days prior to study entry

– Severe, active co-morbidity, defined as follows:

– Unstable angina and/or congestive heart failure requiring hospitalization within
180 days (6 months) prior to registration

– Transmural myocardial infarction within 180 days (6 months) prior to registration

– History of stroke, cerebral vascular accident (CVA), or transient ischemic attack
within 180 days (6 months) prior to registration

– Acute bacterial or fungal infection requiring intravenous antibiotics at the time
of registration

– Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of registration

– Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

– Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease
Control and Prevention (CDC) definition; note, however, that human
immunodeficiency virus (HIV) testing is not required for entry into this protocol

– Known coagulopathy that increases risk of bleeding or a history of clinically
significant hemorrhages in the past

– History of non-healing wounds or ulcers, or bone fractures within 90 days (3
months) prior to registration

– History of venous or arterial thromboembolism within 12 months prior to
registration

– Prior allergic reaction to the study drugs involved in this study

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Phase III Study of Rindopepimut/GM-CSF in Patients With Newly Diagnosed Glioblastoma

This 2-arm, randomized, phase III study will investigate the efficacy and safety of the
addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer
effects in patients who have tumors that express the EGFRvIII protein) to the current
standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of
brain cancer.

All patients will be administered temozolomide, the standard treatment for glioblastoma. Half
the patients will be randomly assigned to receive rindopepimut and half the patients will be
randomly assigned to receive a control called keyhole limpet hemocyanin.

Patients will be treated in a blinded fashion (neither the patient or the doctor will know
which arm of the study the patient is on). Patients will be treated until disease progression
or intolerance to therapy and all patients will be followed for survival.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria-

Among other criteria, patients must meet the following conditions to be eligible for the
study:

1. Adult patients, ≥ 18 years old

2. Newly diagnosed glioblastoma

3. Attempted surgical resection followed by conventional chemoradiation

4. Documented EGFRvIII positive tumor status by a Sponsor designated laboratory

5. No evidence of progressive disease from the post-operative period to the
post-chemoradiation period

6. Candidate for, and agrees to receive, adjuvant (maintenance) temozolomide therapy

7. Systemic corticosteroid therapy at ≤2 mg of dexamethasone or equivalent per day for at
least 3 days prior to randomization

8. WHO-ECOG Performance Status ≤ 2

9. Patients of childbearing/reproductive potential will be instructed to use birth
control as defined by your doctor.

Exclusion Criteria-

Among other criteria, patients who meet the following conditions are NOT eligible for the
study:

1. Stereotactic biopsy only (without further surgical resection)

2. Presence of diffuse leptomeningeal disease, gliomatosis cerebri, or infratentorial
disease.

3. History, presence, or suspicion of metastatic disease

4. Patients who have received any additional treatment for glioblastoma, aside from
surgical resection and chemoradiation with temozolomide

5. Active systemic infection requiring treatment

6. History of any malignancy (other than glioblastoma) during the last three years except
non-melanoma skin cancer, in situ cervical cancer, treated superficial bladder cancer,
cured, early-stage prostate cancer in a patient with PSA level less than ULN,or other
carcinoma in situ that has been adequately treated and cured.

7. Planned major surgery

8. Evidence of current drug or alcohol abuse

9. Known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF
(sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of
anaphylactic reactions to shellfish proteins

10. Severe acute or chronic medical or psychiatric condition or laboratory abnormality
that could increase the risk associated with participating in a clinical trial

11. Women who are pregnant or lactating

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

GRN1005 Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases

The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in
patients with brain metastases from breast cancer. For patients with HER2 positive metastatic
breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per
standard-of-care practice.

In addition, this study will evaluate the ability of 18F-FLT to determine if the amount of
change in the uptake in the brain metastases from breast cancer after GRN1005 treatment,
correlates with intra-cranial response (for patients enrolled at NCI).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Key Inclusion Criteria:

1. Age ≥ 18 years

2. Histologically or cytologically-documented breast cancer (HER2 status and ER/PgR
status must be known)

3. Brain metastasis from breast cancer with or without prior WBRT

4. At least one radiologically-confirmed and measurable metastatic brain lesion (≥ 1.0 cm
in the longest diameter) by Gd-MRI of the brain < 14 days prior to first dose (Metastatic brain lesions previously treated with SRS may not be target or non-target lesions) 5. Patients must be neurologically stable: On stable doses of corticosteroids and anticonvulsants (not EIAEDs, including phenytoin, phenobarbitol, carbamazepine, fosphenytoin, primidone, oxcarbazepine) for ≥ 5 days prior to obtaining the baseline Gd-MRI of the brain and ≥ 5 days prior to first dose 6. KPS ≥ 70% 7. Completed WBRT for intra-cranial lesions ≥ 28 days prior to first dose Key Exclusion Criteria: 1. NCI CTCAE v4.0 Grade ≥ 2 neuropathy 2. CNS disease requiring immediate neurosurgical intervention (e.g., resection, shunt placement, etc.) 3. Known leptomeningeal disease [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer’s Disease Treated With Crenezumab

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term
safety and tolerability of crenezumab in participants with mild to moderate Alzheimer’s
disease who have participated in and completed the treatment period of the Phase II Study
ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study
ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on
study treatment is 144 weeks.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73
visit

– Adequate visual and auditory acuity, in the investigator’s judgment, to allow for
neuropsychological testing

– Availability of a person (“caregiver”) who can provide information on activities of
daily living and behavior in order to complete the study-specific assessments

– Diagnosis of probable Alzheimer’s disease according to the National Institute on
Neurological and Communication Disease and Stroke/Alzheimer’s Disease and Related
Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)

– Mini-Mental State Examination (MMSE) score of 10 or more at screening (Folstein et al.
1975)

– For male participants with partners with reproductive potential, agreement to use a
reliable means of contraception (e.g., condoms) during the study and for at least 8
weeks following the last dose of study drug

– For female participants, a negative pregnancy test at screening

Exclusion Criteria:

– Early treatment and/or study discontinuation prior to completion of the Week 73 visit
of Genentech Study ABE4869g or ABE4955g

– Early discontinuation from the treatment schedule of a prior version of Study GN28525
for safety reasons. If treatment discontinuation occurred for safety reasons,
participants may not re-start dosing on extended treatment schedules offered in
amendments to Study GN28525

– Inability to tolerate Magnetic Resonance Imaging (MRI) procedures or contraindication
to MRI

– Female participants with reproductive potential: Female participants must either have
undergone documented surgical sterilization or have not experienced menstruation for
at least 12 consecutive months

– Severe or unstable medical condition that, in the opinion of the investigator or
Sponsor, would interfere with the participant’s ability to complete the study
assessments or would require the equivalent of institutional or hospital care

– History or presence of clinically evident vascular disease potentially affecting the
brain

– History of severe, clinically significant central nervous system trauma

– History or presence of clinically relevant intracranial tumor

– Presence of infections that affect the brain function or history of infections that
resulted in neurologic sequelae

– History or presence of systemic autoimmune disorders potentially causing progressive
neurologic disease

– History or presence of a neurologic disease other than Alzheimer’s disease that may
affect cognition

– History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric, human, or humanized antibodies or fusion proteins

– Evidence of malignancies (except squamous cell cancer or basal cell cancer of the
skin), acute infections, renal failure that requires dialysis, or other unstable
medical disease not related to Alzheimer’s disease that, in the investigator’s
opinion, would preclude participant’s participation. Cancer that is not being actively
treated with anti-cancer therapy or radiotherapy as well as cancers which are
considered to have low probability of recurrence are allowed

– History or presence of atrial fibrillation that, in the investigator’s judgment, poses
a risk for future stroke

– Chronic kidney disease of Stage greater than or equal to (>=) 4, according to the
National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI)
guidelines for chronic kidney disease (CKD)

– Impaired hepatic function

– Impaired coagulation (activated partial thromboplastin time [aPTT] greater than [>] 1.2 times upper limit of normal [ULN])

– Platelet count less than (<) 100,000 per microliter (mcL) - Presence at screening of superficial siderosis of central nervous system, more than 8 cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage - Presence at screening of any other significant cerebral abnormalities, including ARIA-E - Treatment with anticoagulation medications within 2 weeks prior to enrollment. Clopidogrel, dipyridamole, and aspirin are permitted - Treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates within 2 weeks prior to enrollment. All other antidepressants and atypical antipsychotics are allowed with certain restrictions as defined in the protocol - Chronic use of opiates, opioids, or benzodiazepines - Any biologic therapy within 75 weeks prior to enrollment - Any investigational agent (other than crenezumab) within 75 weeks prior to enrollment - Treatment with anticholinergic antidepressants, typical antipsychotics, barbiturates, or narcotics within 5 half-lives or 3 months prior to screening, whichever is longer. All other antidepressants and atypical antipsychotics are allowed. Chronic use of benzodiazepines is not allowed; however, the intermittent use of benzodiazepines is allowed, except within 2 days prior to any neurocognitive assessment [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Imaging of Brain Amyloid Plaques in the Aging Population

This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of
this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to
ascertain the relationship between change in amyloid burden over time, and concurrent change
in clinical status.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Age 30-100

– Subjects who have completed or are scheduled to undergo the neurological evaluation
procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative
disease clinics.

Exclusion Criteria:

– Subjects unable to lie down without moving for 10 minutes

– Women who are pregnant or cannot stop breast feeding for 24 hours

– Claustrophobic patients unable to tolerate the scans

– Standard safety exclusionary criteria for MRI such as metallic foreign bodies,
pacemaker, etc.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer’s Disease

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment
of subjects with mild to moderate Alzheimer’s Disease.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Diagnosis of all cause dementia and probable Alzheimer’s disease

– Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score
of 14-26 (inclusive)

– Age < 90 years - Modified Hachinski ischemic score of ≤ 4 - Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study - Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent - Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug - If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study. - Able to comply with the study procedures Exclusion Criteria: - Significant central nervous system (CNS) disorder other than Alzheimer's disease - Significant focal or vascular intracranial pathology seen on brain MRI scan - Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes - Epilepsy - Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders - Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI - Resides in hospital or moderate to high dependency continuous care facility - History of swallowing difficulties - Pregnant or breastfeeding - Glucose-6-phosphate dehydrogenase deficiency - History of significant hematological abnormality or current acute or chronic clinically significant abnormality - Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator - Clinically significant cardiovascular disease or abnormal assessments - Preexisting or current signs or symptoms of respiratory failure - Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease - Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years - Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients - Treatment currently or within 3 months before Baseline with any of the following medications: - Tacrine - Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study) - Carbamazepine, primidone - Drugs with a warning or precaution in the labeling about methemoglobinemia at approved doses - Current or prior participation in a clinical trial as follows: - Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo) - A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Study of Idalopirdine in Patients With Mild – Moderate Alzheimer’s Disease Treated With Donepezil

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic
treatment of patients with mild-to-moderate Alzheimer’s disease (AD).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– The patient has a knowledgeable and reliable caregiver.

– The patient is an outpatient.

– The patient has probable AD.

– The patient has mild to moderate AD.

– Stable treatment with donepezil.

– The patient, if a woman, must have had her last natural menstruation ≥24 months prior
to baseline, OR be surgically sterile.

– The patient, if a man, agrees to protocol-defined use of effective contraception if
his female partner is of childbearing potential, OR must have been surgically
sterilised prior to the screening visit.

Exclusion Criteria:

– The patient has evidence of any clinically significant neurodegenerative disease, or
other serious neurological disorders other than AD.

– The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
Text Revision (DSM-IV-TR) Axis I disorder other than AD.

– The patient has evidence of clinically significant disease.

– The patient’s donepezil therapy is likely to be interrupted or discontinued during the
study.

– The patient is currently receiving memantine or has taken memantine within 2 months
prior to screening.

Other inclusion and exclusion criteria may apply.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild AD

The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a
naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer’s disease
participants. The primary goal is to determine the maximally tolerated dose.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Men or postmenopausal women

– 55 years of age or older

– Diagnosis of MCI due to AD or mild AD

– MMSE > 20 at screen

– Capacity to provide informed consent

– Residing in the community with a caregiver able to accompany the patient to clinic
visits

– No medical contraindications to participation

– Willingness to comply with study procedures

Exclusion Criteria:

– Use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other
drugs that might interact with the GABA-A receptor complex

– Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury,
substance abuse, malignancy

– Clinically significant laboratory or ECG abnormality

– MRI indicative of any other significant abnormality, including but not limited to
evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations,
subdural hematoma, or space occupying lesions

– Any condition that would contraindicate an MRI such as the presence of metallic
objects in the eyes, skin, heart, or body

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

The purpose of this study is to test whether an investigational drug called solanezumab can
slow the progression of memory problems associated with brain amyloid (protein that forms
plaques in the brains of people with Alzheimer Disease [AD]).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30

– Has a global Clinical Dementia Rating (CDR) scale score at screening of 0

– Has a Logical Memory II score at screening of 6 to 18

– Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain
amyloid pathology at screening

– Has a study partner that is willing to participate as a source of information and has
at least weekly contact with the participant (contact can be in-person, via telephone
or electronic communication)

Exclusion Criteria:

– Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at
screening or baseline

– Lacks good venous access, such that intravenous drug delivery or multiple blood draws
would be precluded

– Has current serious or unstable illness including cardiovascular, hepatic, renal,
gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic,
or hematologic disease or other conditions that, in the investigator’s opinion, could
interfere with the analyses of safety and efficacy in this study

– Has had a history within the last 5 years of a serious infectious disease affecting
the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma
resulting in protracted loss of consciousness

– Has had a history within the last 5 years of a primary or recurrent malignant disease
with the exception of any in situ cancer that was appropriately treated and is being
appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or
in situ prostate cancer with normal prostate-specific antigen post-treatment

– Has a known history of human immunodeficiency virus (HIV), clinically significant
multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions
(including, but not limited to, erythema multiforme major, linear immunoglobulin A
dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

– Is clinically judged by the investigator to be at serious risk for suicide

– Has a history within the past 2 years of major depression or bipolar disorder as
defined by the most current version of the Diagnostic and Statistical Manual of Mental
Disorders (DSM)

– Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as
defined by the most current version of the DSM

Open-Label Inclusion Criteria:

– All participants who complete the placebo-controlled period will be allowed to
continue into the open-label period

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808

[F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the
human brain.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Low Probability for AD Participants (Group 1)

– Participant is of any race/gender/ethnicity who has reached his or her 55th birthday
at the time of informed consent.

– Participant provides written informed consent Participant is capable of complying with
study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education

– In the Investigator‟s opinion, participant has a low probability of being currently
positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined
in APPENDIX VI of XXX protocol

– Participant has no significant hepatic or renal disease as defined by previous medical
history and lab results are within the following ranges: Total bilirubin within 2x
institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of
normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x
institutional upper limits of normal BUN within 2x institutional upper limits of
normal

High Probability for AD Participants (Group 2)

– Participant is of any race/gender/ethnicity who has reached his or her 55th birthday
at the time of informed consent.

– Participant or participant‟s legally acceptable representative provides written
informed consent Participant is capable of complying with study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education In the Investigator‟s opinion,
*participant has a high probability of being currently positive for AD that is
determined by a Mini Mental State Examination (MMSE < 17) defined in APPENDIX VI of XXX protocol - Participant has no significant hepatic or renal disease as defined by previous medical history, and lab results are within the following ranges: Total bilirubin within 2x institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x institutional upper limits of normal BUN within 2x institutional upper limits of normal [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807

[F-18]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the
human brain.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria; Low Probability for AD Participants (Group 1)

– Participant has reached his or her 55th birthday at the time of informed consent
(Participant is male or female of any race / ethnicity)

– Participant provides written informed consent

– Participant is capable of complying with study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education

– In the Investigator’s opinion, participant has a low probability of being currently
positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined
in APPENDIX VI of protocol T807000, IND 114102

– Participant has no significant hepatic or renal disease as defined by previous medical
history and lab results are within the following ranges:

– Total bilirubin within 2x institutional upper limits of normal

– AST (SGOT) ≤ 2.5 x institutional upper limits of normal

– ALT (SGPT) ≤ 2.5 x institutional upper limits of normal

– Creatinine ≤ 2x institutional upper limits of normal

– BUN within 2x institutional upper limits of normal

High Probability for AD Participants (Group 2)

– Participant has reached his or her 55th birthday at the time of informed consent
(Participant is male or female of any race / ethnicity)

– Participant or participant’s legally acceptable representative provides written
informed consent

– Participant is capable of complying with study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education

– In the Investigator’s opinion, participant has a high probability of being currently
positive for AD that is determined by a Mini Mental State Examination (MMSE < 17) defined in APPENDIX VI of protocol T807000, IND 114102. - Participant has no significant hepatic or renal disease as defined by previous medical history, and lab results are within the following ranges: - Total bilirubin within 2x institutional upper limits of normal - AST (SGOT) ≤ 2.5 x institutional upper limits of normal - ALT (SGPT) ≤ 2.5 x institutional upper limits of normal - Creatinine ≤ 2x institutional upper limits of normal - BUN within 2x institutional upper limits of normal Exclusion Criteria; All Participants - Female participant is pregnant or nursing - Participant has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation - Participant has other neurodegenerative disease that is associated with cognitive impairment or dementia - Participant has a medical condition that might be associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome - Participant has a history of significant cerebrovascular disease - Participant has previously received [F-18]T807 at any time - Participant has been involved in an investigative, radioactive research procedure within the past 14 days - Participant has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality - Participant has a history in the last five years of significant prescription or non-prescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer’s Disease

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124
compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer’s disease
currently receiving stable treatment or previously treated with an acetylcholinesterase
inhibitor.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Ages ≥55 and ≤85 years

– Informed consent form (ICF) signed by the subject or legally acceptable representative
before any study-specific procedures for the subject are performed and an ICF signed
by the support person/caregiver before any study-specific procedures for the support
person/caregiver are performed

– Clinical diagnosis of dementia due to probable AD consistent with criteria established
by a workgroup of the National Institute on Aging and the Alzheimer’s Disease
Association

– Clinical decline within 12 months before screening and onset of symptoms at least 12
months or longer before screening, which may include any documented cognition,
functional, or other objective assessment or the clinical judgment of the investigator
or the subject’s referring physician that the subject has experienced a clinical
decline within the last 12 months

– Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12
months before screening, with findings consistent with the diagnosis of dementia due
to AD without any other clinically significant comorbid pathologies. If an MRI or CT
scan is unavailable or occurred greater than 12 months before screening, this
assessment should be completed and the findings confirmed before the subject enters
the run-in period (Day -14) (copy of the report will be available at the study site)

– Mini-Mental State Examination (MMSE) score ≥14 and ≤24 at screening and confirmed on
Day 1 prior to randomization (fluctuations of ±2 points are acceptable on Day
1/baseline)

– Clinical Dementia Rating Global score (CDR-GS) ≥1 (at least mild dementia) at
screening and confirmed on Day 1 prior to randomization

– Modified Hachinski Ischemic Scale (mHIS) score ≤4 at screening

– Fertile, sexually active subjects (men and women) must use an effective method of
contraception during the study. Female subjects and the female partner of male
subjects must be surgically sterile (hysterectomy or bilateral tubal ligation),
postmenopausal for at least 1-year, or willing to practice adequate methods of
contraception if of childbearing potential (defined as consistent use of combined
effective methods of contraception [including at least 1 barrier method])

– Reliable and capable support person/caregiver, who if not living in the same
household, interacts with the subject approximately 4 times per week and will be
available to attend clinic visits in person when possible

– Subject living at home, senior residential setting, or an institutional setting
without the need for continuous (ie, 24-hour) nursing care

– General health status acceptable for participation in a 26-week study

– Fluency (oral and written) in the language in which the standardized tests will be
administered

– Receiving a stable dose of an acetylcholinesterase inhibitor (AChEI) (donepezil,
rivastigmine or galantamine) for at least 3 months (90 days) before screening and with
continuous dosing for at least 6 months OR not presently receiving an AChEI (at least
30 days before screening), but with a history of previous AChEI treatment (subjects
receiving donepezil 23 mg currently or within 3 months before screening are
ineligible)

Exclusion Criteria:

– Exposure to an experimental drug, experimental biologic or experimental medical device
within 2 months (60 days) before screening

– Prior participation in an amyloid vaccination clinical study at any time in the past
or completion of a passive amyloid vaccination study within 6 months before screening

– Inability to swallow a tablet

– In the judgment of the investigator, inability of the subject or the support
person/caregiver to complete a 26-week study

– Inability to be ≥75% compliant with single-blind study drug

– Inability to adequately cooperate or complete the cognitive testing procedures or any
study assessment

– Residence in a skilled nursing facility

– Untreated vitamin B12 or folate deficiency (if treated, must be stably treated for at
least 6 months before screening)

– Clinically significant (in the judgment of the investigator) abnormal serum
electrolytes (sodium, potassium, magnesium) after repeat testing

– Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating
hormone level and thyroid supplementation dose must be stable for at least 6 months
before screening)

– Insufficiently controlled diabetes mellitus (in the judgment of the investigator) or
requiring insulin

– Renal insufficiency (serum creatinine >2.0 mg/dL)

– Malignant tumor within 3 years before screening (except squamous and basal cell
carcinoma or cervical carcinoma in situ or localized prostate cancer)

– Female subjects who are pregnant, nursing, or planning to become pregnant during the
study

– Unstable medical condition that is clinically significant in the judgment of the
investigator

– Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times the upper limit
of normal

– History of myocardial infarction or unstable angina within 6 months before screening

– History of more than 1 myocardial infarction within 5 years before screening

– Clinically significant (in the judgment of the investigator) cardiac arrhythmia
(including atrial fibrillation), cardiomyopathy, or cardiac conduction defect
(subjects with a pacemaker are acceptable)

– Symptomatic hypotension or hypertension (supine diastolic blood pressure >95 mmHg) (in
the judgment of the investigator)

– Clinically significant abnormality on screening or baseline electrocardiogram (ECG),
including but not necessarily limited to a confirmed corrected QT interval (QTc) value
≥450 msec for males or ≥470 msec for females. In subjects with a QRS value >120msec,
those with a QTc value <500 msec may be eligible following discussion with the Medical Monitor. - Stroke within 18 months before screening, or history of a stroke concomitant with onset of dementia - History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI - Head trauma with clinically significant (in the judgment of the investigator) loss of consciousness within 12 months before screening or concurrent with the onset of dementia - Onset of dementia secondary (in the judgment of the investigator) to cardiac arrest, surgery with general anesthesia, or resuscitation - Specific degenerative central nervous system (CNS) disease diagnosis other than AD (eg, Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Fronto-Temporal Dementia, Parkinson's disease) - Subjects with no history of prior treatment with an AChEI (donepezil, rivastigmine, or galantamine) - Memantine currently or within 30 days before screening - Antipsychotics; low doses (in the judgment of the investigator, except clozapine) are allowed only if given for sleep disturbances, agitation and/or aggression, and only if the subject has received a stable dose for at least 3 months before screening (but not within 8 hours before any cognitive test) - Tricyclic antidepressants and monoamine oxidase inhibitors; all other antidepressants are allowed only if the subject has received a stable dose for at least 3 months before screening - Antiepileptic medications if taken for control of seizures - Chronic intake of opioid-containing analgesics - Sedating H1 antihistamines - Nicotine therapy (including the patch), varenicline (Chantix), or similar therapeutic agent within 30 days before screening - Clinically significant urine drug screen or serum alcohol test result in the judgment of the investigator - History of ischemic colitis or ischemic enterocolitis [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms

The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER®
AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Infrarenal AAA > or equal to 4.5 cm in diameter

– Proximal infrarenal aortic neck length > or equal 15mm

– Anatomy meets 31mm EXCLUDER specification criteria

– Access vessel able to receive 20 Fr. introducer sheath

– Life expectancy >2 years

– Surgical candidate

– ASA Class I, II, III, or IV

– NYHA Class I, II, III

– 21 years of age or older

– Male or infertile female

– Ability to comply with protocol requirements including follow-up

– Signed Informed Consent Form

Exclusion Criteria:

– Mycotic or ruptured aneurysm

– Participating in another investigational device or drug study within 1 year

– Documented history of drug abuse within 6 months

– Coexisting thoracic aortic aneurysm (50% larger than proximal aorta)

– Myocardial infarction or cerebral vascular accident within 6 weeks

– Pulmonary insufficiency requiring chronic home oxygen therapy or inability to ambulate
due to pulmonary function

– Renal insufficiency (Creatinine > 2.5 mg/dL) without dialysis

– Iliac anatomy that would require occlusion of both internal iliac arteries

– “Planned” occlusion or reimplantation of significant mesenteric or renal arteries

– “Planned” concomitant surgical procedure or previous major surgery within 30 days

– Previous prosthesis placement in the same position of the aorta or iliac arteries

– Degenerative connective tissue disease, e.g., Marfans and Ehlers Danlos Syndrome

– Proximal neck angulation > 60 degrees

– Presence of significant thrombus at arterial implantation sites

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Evaluation of the GORE® C3 Delivery System Module

This is an observational Registry designed to obtain early data on the use of the GORE®
EXCLUDER® AAA Endoprosthesis with C3 Delivery System.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. Minimum age required by local regulations (as applicable)

2. Indication for aortic endovascular stent graft repair as determined by the treating
physician (refer to current Instructions for Use of the GORE® EXCLUDER® AAA
Endoprosthesis with C3 Delivery System)

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Endovascular Magnesium Sampling in Acute Stroke

This investigation will address the safety and feasibility of distal, intra-arterial sampling
through endovascular access, in acute stroke patients. Levels of Magnesium will be measured
in the region of infarct in patients who had been treated with intravenous Magnesium therapy
following an acute stroke. This study attempts to address whether the traditional intravenous
means of neuroprotectant administration achieves adequate concentration of the therapeutic
agent in the area of diseased tissue.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,

2. Patient already enrolled in the NIH FAST-MAG clinical trial,

3. Patient’s clinical attending physician plans mechanical embolectomy procedure as part
of routine clinical care.

4. Age 40-95 inclusive (age criteria for FAST-MAG Trial).

Exclusion Criteria:

1. Technical inability to navigate microcatheter to target clot.

2. Patient or surrogate unavailable for consent

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Intra-arterial Magnesium Administration for Acute Stroke

Stroke is the second leading cause of death and the leading cause of adult disability
worldwide. This investigation will address the safety and feasibility of directed,
intra-arterial Magnesium measurement and therapy, through endovascular access, in acute
stroke patients. The proposal represents the first study to directly quantify levels of a
systemically administered neuroprotectant in the region of cerebral ischemia. It also
establishes a novel endovascular platform for direct delivery of neuroprotective agents to
ischemic cerebral tissue distal to an occlusive thrombus. This research seeks to improve
patient care by establishing a novel delivery mechanism for the rescue of threatened brain
parenchyma that can be administered rapidly following acute stroke. If successful, this
selective distribution will allow delivery to “at risk” tissue in a rapid manner. Salvage of
viable, but threatened, penumbral tissue could afford stroke patients an increased
probability of favorable long term outcome. The investigators hypothesize that endovascular,
intra-arterial, Magnesium administration will deliver high concentration of this
neuroprotective agent to otherwise inaccessible cerebral territories, while limiting systemic
concentrations. The proposed investigation will evaluate the safety and feasibility of this
novel treatment technique

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. Patient with acute cerebral ischemia due to ICA or MCA occlusion,

2. Patient’s clinical attending physician plans mechanical embolectomy procedure as part
of routine clinical care.

3. Age 21-95.

Exclusion Criteria:

1. Severe renal impairment with creatinine 3.0 or higher,

2. Myasthenia gravis,

3. Second or third degree heart block without a pacemaker in place,

4. Technical inability to navigate microcatheter to target clot,

5. Patient already enrolled in another experimental treatment trial. Exclusion criteria
1-3 are all contraindications to magnesium therapy.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Tonsillectomy in Adults With Tonsillar Hypertrophy and Obstructive Sleep Apnea

The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive
sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with
normal soft palate and uvula length.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– At least 18 years of age

– Documented obstructive sleep apnea (with central apneas of the total number of apneas
plus hypopneas)

– Able to complete all forms in English and follow-up appointments

– Willing to undergo 3 home sleep studies; and markedly hypertrophic (3+ or 4+) tonsils

– Tonsil size of 3+ or 4+ corresponds to tonsils that occupy more than 50% of the space
between the tonsillar fossa (side of the throat) and midline

Exclusion Criteria:

– No craniofacial abnormality

– No history of COPD, untreated psychological disorder, other sleep disorder, alcohol or
drug abuse

– Body mass index <35 kg/m2 - Unable to tolerate other treatments for obstructive sleep apnea - Soft palate length > 4 cm

– Uvula length > 2 cm

– No significant nasal obstruction

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Magnetic Resonance Imaging in Obstructive Sleep Apnea

There is a fundamental gap in the investigators ability to design effective surgical
treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate
non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful
outcome ranging from 5% to 65% for individual or combination procedures. To predict – and
thereby to improve – outcomes, the investigators must determine what predicts surgical
success. This project will compare findings from two evaluations: drug-induced sleep
endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated
important benefits, but it has important limitations. Upper airway MRI is the most complete
evaluation performed during wakefulness, making it conducive to broad application and less
expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The
investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe
OSA. In addition to history, physical examination, and polysomnogram (sleep study), all
subjects will undergo DISE and MRI to characterize the pattern of obstruction. The
investigators will examine the association between DISE and MRI, focusing on specific DISE
findings that have been associated with surgical outcomes. The investigators
multidisciplinary team has substantial expertise and experience in OSA investigation, DISE,
and upper airway MRI.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– age ≥ 21 years; moderate to severe OSA (AHI ≥15 events/hour)

– body mass index <40 kg/m2. Exclusion Criteria: - prior OSA surgery - known neurologic, cardiac, pulmonary, renal, or hepatic disorders - psychiatric problems except for treated depression or mild anxiety - co-existing sleep disorder other than OSA - other contraindication to DISE or MRI such as propofol allergy. [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea

Prospective, interventional cohort study of drug-induced sleep endoscopy (DISE) to evaluate
the upper airway in a cohort of obstructive sleep apnea (OSA) surgical patients. This study
has investigated the reliability of this technique, demonstrating moderate-substantial
interrater and test-retest reliability. This research has also compared DISE findings to
those of the lateral cephalogram X-ray and examined DISE findings in individuals who have not
responded to previous sleep apnea surgery. These papers have been published and available
through PubMed. Additional research is ongoing, with examination of DISE findings, comparison
to other evaluation techniques, and the association between DISE findings and surgical
outcomes.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Adult patients with OSA considering surgical treatment

Exclusion Criteria:

– Minors

– Pregnant women

– Patients unable to provide informed consent in English themselves

– Prisoners

– Allergy to propofol, soybean oil, egg lecithin or glycerol

– Other contraindication to use of propofol (decision of anesthesiologist or
otolaryngologist.)

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Recruiting

DuraSeal Exact Spine Sealant System Post-Approval Study

This is a non-randomized, post-approval study to further evaluate the rate of post-operative
Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive
DuraSeal Exact Spine Sealant System.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Subject is 18 years of age or older

– Subject had a spinal procedure where a dural opening (either intentional or
incidental) occurred and was treated with either:

– DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR

– Any other method of sealing the dura with the exception of DuraSeal™ Sealant
-either spinal or cranial. (Control group ONLY)

– Subject, or authorized representative, has been informed of the nature of the study
and has provided written informed consent approved by the appropriate Institutional
Review Board (IRB) of the respective clinical site prior to the collection of study
data.

– Prospective subjects: Consent must be obtained within 24 hours of surgery stop
time.

– Retrospective subjects (Control group specific): IRB approval may be granted to
individual sites to waive requirement for informed consent.

Exclusion Criteria:

– The investigator determines that the subject will not be able to comply with the
required follow-up visits (not required if subject is being enrolled retrospectively-
control group ONLY)

– Pregnant or breastfeeding females (as documented in the medical records; no testing
beyond the site’s standard of care is required)

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)

The purpose of this research study is to gather scientific information about the
effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive
substance) in subjects with acute spinal cord injury.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. Acute traumatic injury to the cervical neurological spinal cord as follows:

1. American Spinal Injury Association Impairment Scale A with a level of injury at
either C4, C5, C6, or C7 (for C4, the subject must have at least 1 point of motor
activity within the ZPP inclusive of C5 to T1). In addition, the AIS A subject
may be included if ALL of the following are present 1) the most caudal intact
sensory segment (both pinprick and light touch) is C3, 2) at least one side
(right or left) has both intact pinprick and light touch sensation in the C4
dermatome, AND 3) at least 1 point of motor activity within the ZPP inclusive of
C5 to T1

2. American Spinal Injury Association Impairment Scale B or C with a neurological
level of injury at either C3, C4, C5, C6, C7, or C8 AND a total LEMS of 5 or
fewer motor points

2. Closed single traumatic spinal cord injury occurring within 12 hours of first dosing

3. Male or female AIS A subjects ≥ 16 to ≤ 80 years and male or female cervical AIS B or
C subjects ≥16 to ≤70 years

4. Females of childbearing potential and males must agree to maintain adequate
contraception for the first 35 days of the study

Exclusion Criteria:

1. Unable to obtain informed consent (either from the subject or from the subject’s LAR)

2. Women who are breastfeeding (if unwilling to stop for the first 35 days of the study)
or who are pregnant

3. Coma or significant impairment in the level of consciousness that interferes with the
performance or interpretation of protocol specified assessments

4. Any disease, concomitant injury, or condition that interferes with the performance or
interpretation of the protocol specified assessments

5. Unable, as determined by the investigator, or unwilling to discontinue use of potent
P-glycoprotein (P-gp) inhibitors for the first 35 days of the study

6. Unable, as determined by the investigator, or unwilling to discontinue use of potent
cytochrome P450 (CYP) 3A4/5 inducers for the first 35 days of the study

7. Renal compromise (serum creatinine greater than 1.5 times the age- and sex-appropriate
upper limit of normal [ULN]) at screening before the first dose of study drug

8. Severe Hepatic dysfunction (serum alanine transaminase [ALT], aspartate transaminase
[AST], and/or gamma-glutamyltransferase [GGT] ALL greater than 2.5 times the age- and
sex-appropriate ULN) or hepatic impairment (detectable ascites, serum bilirubin
greater than 2 mg/dL, serum albumin less than 3.5 g/dL, and prothrombin time prolonged
by more than 6 seconds above the ULN for the local laboratory in the absence of
anticoagulant therapy) at screening before the first dose of study drug

9. Concomitant spinal cord injury or abnormality as determined by routine imaging:

1. Conclusive radiological evidence of complete spinal cord transection

2. Multiple injuries to the neurological spinal cord at different levels

10. History of symptomatic cervical spinal stenosis with myelopathy as a factor
confounding subject assessment

11. Unlikely to be available for follow-up as specified in the protocol

12. Participated in a previous clinical study and received an investigational product
within 30 days of screening

13. Previous exposure to SUN13837

14. Allergy to SUN13837 or any of its excipients

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

ECU-MG-302: An Extension Trial of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis

To evaluate the safety and efficacy of eculizumab in the treatment of refractory gMG as an
extension trial for the subjects who have participated in the ECU-MG-301 trial.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. Subject has completed the ECU-MG-301 trial.

2. Subject has given written informed consent.

3. Subject is willing and able to comply with the protocol requirements for the duration
of the trial.

4. Female subjects of child-bearing potential must have a negative pregnancy test (serum
human chorionic gonadotropin [HCG]). All subjects must practice an effective, reliable
and medically approved contraceptive regimen during the trial and for up to 5 months
following discontinuation of treatment.

Exclusion Criteria:

1. Subjects who withdrew from the ECU-MG-301 trial as a result of an AE related to trial
drug.

2. Female subjects who are pregnant, breastfeeding or intend to conceive during the
course of the trial.

3. Any medical condition or circumstances that, in the opinion of the Investigator, might
interfere with the subject’s participation in the trial, pose any added risk for the
subject, or confound the assessment of the subjects.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

The Evaluation of Belimumab in Myasthenia Gravis (MG)

Study BEL115123 is a randomized, placebo-controlled, double-blind, multinational study of
belimumab (10 mg/kg) to investigate the efficacy and safety of belimumab in subjects with MG.
The study will enroll male and female outpatients (> or equal to 18 years of age) with a
diagnosis of MG who are 1) acetylcholine receptor (AChR) antibody positive or muscle specific
kinase (MuSK) antibody positive, 2) on current standard of care therapy, and 3) continue to
exhibit signs of MG. The study will include 3 phases: a 4 week screening period, a 24 week
treatment period, and a 12 week follow-up period. IP will be administered intravenously on
Days 0, 14, 28 and then every 28 days through and including Week 20. At Week 24, primary
outcomes will be obtained. Follow up evaluations will be conducted at Weeks 28, 32 and 36 for
all subjects. The primary objective of this study is to assess the efficacy of belimumab as
evaluated by the change in the quantitative myasthenia gravis (QMG) score.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– 18 years and older, with life expectancy of greater than 1 year.

– MG of class II to IVa inclusive.

– Acetylcholine receptor (AChR) or muscle specific kinase (MuSK) antibody positive.

– Stable dose (defined as no dose changes) not exceeding the maximum doses given in
Section 5.6.1 of the following therapy(ies) prior to screening: Cholinesterase
inhibitor(pyridostigmine or equivalent) for at least 2 weeks prior to screening and no
immunosuppressants; Cholinesterase inhibitor (pyridostigmine or equivalent) for at
least 2 weeks prior to screening and/or only one of the following: prednisone (up to
40 mg/day or equivalent) for at least 1 month prior to screening; azathioprine for at
least 6 months prior to screening; mycophenolate for at least 6 months prior to
screening, or cyclosporine for at least 3 months prior to screening; or Cholinesterase
inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to screening
and/or prednisone (up to 20 mg/day or equivalent) for at least 1 month prior to
screening and only one of the following: azathioprine for at least 6 months prior to
screening, mycophenolate for at least 6 months prior to screening, or cyclosporine for
at least 3 months prior to screening

– Quantitative Myasthenia Gravis (QMG) score of 8 or greater, with at least 4 points
derived from signs other than ocular

– A female subject is eligible to participate if she is: Of non-childbearing potential;
Of childbearing potential and NOT pregnant or nursing, has a negative serum pregnancy
test at screening, and agrees to one of the following: Complete abstinence from
penile-vaginal intercourse, when this is the female’s preferred and usual lifestyle,
for the period from consent into the study until 16 weeks after the last dose of
investigational product; or Consistent and correct use of one of the following
acceptable methods of birth control for the period from consent into the study until
16 weeks after the last dose of investigational product: Oral contraceptives (either
combined or progesterone only), Injectable progesterone, Implants of etonogestrel or
levonorgestrel, Estrogenic vaginal ring, Percutaneous contraceptive patches,
Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate
of less than 1% per year, Male partner sterilization (vasectomy with documentation of
azoospermia) prior to the female subject’s entry into the study; this male must be the
sole partner for the subject, Double barrier method: condom and an occlusive cap
(diaphragm or cervical/vault caps) with a vaginal spermicidal agent
(foam/gel/film/cream/suppository).

– Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.

– Single QTc less than 450 msec; or QTc less than 480 msec in subjects with Bundle
Branch Block.

– AST and ALT less than 2xULN; alkaline phosphatase and bilirubin less or = to 1.5xULN
(isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated
and direct bilirubin less than 35%).

Exclusion Criteria:

– Participated in a clinical trial and has received an investigational product within 30
days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer) prior to screening or planning to take
any investigational drug for the planned duration of study participation (6 months
after the last dose of study drug).

– Presence or previous history of thymoma.

– Thymectomy within 12 months

– Clinically significant (in the opinion of investigator) abnormal laboratory values.

– Pregnant females as determined by positive (serum) hCG test at screening or prior to
dosing, or lactating females or planning to become pregnant within 16 weeks after last
dose of investigational product.

– History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the investigator or GSK
Medical Monitor, contraindicates their participation.

– May require (in the opinion of investigator) treatment with IVIg and/or plasmapheresis
during the 24 week treatment period.

– Have received IVIg and/or plasmapheresis within 90 days prior to screening.

– Have received any other biopharmaceutical agent (except IVIg as described in exclusion
criteria #8) in the 364 days prior to screening.

– Have received treatment with any B cell targeted therapy (e.g., rituximab, belimumab),
at any time.

– Have received a live vaccine within 30 days of study Day 0 (baseline).

– Have received cyclophosphamide or any other immunosuppressive agent apart from the
ones allowed by the inclusion criteria #4, within the past 6 months.

– Have another medical condition that requires treatment with steroids or
immunosuppressive agents.

– Hospitalization due to infection or use of parenteral antibacterial, antifungal or
antiviral agents within 60 days prior to screening; or history of recurrent or chronic
infection, or currently active systemic infection.

– Have a history of malignant neoplasm within the last 5 years, except for adequately
treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the
uterine cervix.

– Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or
hematopoietic stem cell/marrow transplant.

– Have a historically positive test or test positive at screening for HIV-1, hepatitis B
surface antigen or hepatitis C antibody.

– Have an IgG Grade 3 or greater deficiency (less than or = to 400mg/dL).

– Have an IgA deficiency (IgA less than 10mg/dL).

– Have a history of an anaphylactic reaction to parenteral administration of contrast
agents, human or murine proteins or monoclonal antibodies.

– Has a progressive medical, neurological or psychological condition or situation that,
in the investigator’s judgment, is likely to cause the subject to be unable or
unwilling to participate in study procedures, to complete all scheduled assessments,
or precludes accurate assessments.

– Is currently abusing drugs or alcohol or has history of abuse in the last 12 months.

– Subjects who have evidence of serious suicide risk including any history of suicidal
behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the
C-SSRS in the last 2 months or who in the investigator’s judgment, pose a significant
suicide risk.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Efficacy and Safety Study of Z160 in Subjects With Postherpetic Neuralgia

This study will compare Z160 and placebo in patients with Postherpetic Neuralgia for safety
and efficacy for a period of 6 weeks.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Provide written informed consent.

– Either sex but must be aged >=18 years.

– Diagnosis of PHN as defined by the presence of pain in the area affected by herpes
zoster >=6 months after the herpes zoster skin rash has healed.

– Pain score over the last week of >=3 and <=8 on the PI-NRS - If female, the subject must be postmenopausal , surgically sterilized for >=3 months
before the screening visit, or agree to use 2 reliable methods of contraception if of
childbearing potential. If male, the subject must agree to use condoms.

– Willing and able to comply with all study procedures.

Exclusion Criteria:

– Severe pain caused by diseases other than PHN.

– Neurolytic or neurosurgical therapy for PHN within 6 months of screening (subjects who
received a spinal cord stimulator implant at least 6 months before screening are
eligible, but the settings need to remain stable during the double blind study period
without use of a magnet).

– History of seizure, excluding pediatric febrile seizures, or currently has seizures.

– Stroke or transient ischemic attack (TIA) <=6 months before the screening visit. - History of or a current diagnosis of schizophrenia or bipolar disorder. - Major depressive disorder or generalized anxiety disorder <=6 months before the screening visit. Subjects who are on stable doses of selective serotonin uptake inhibitors (SSRIs) for depression (other than major depressive disorder) are eligible for the study. - Clinically significant alcohol or substance dependency <=1 year before the screening visit - Imminent risk of suicide (positive response to question 4 or 5 on the C-SSRS) or had a suicide attempt within 6 months before the screening visit. - Clinically significant conditions that, in the investigator's opinion, may interfere with the study procedures or compromise the subject's safety. - Malignancy (other than nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma in situ of other organs that was surgically removed >1 year before screening
and has not recurred).

– Condition that is known to interfere with the absorption, distribution, metabolism, or
excretion of drugs.

– Illness within 30 days before screening.

– History of hypersensitivity to calcium channel blockers.

– Multiple drug allergies

– Opioids (at doses exceeding the equivalent of 15 mg of oral morphine) or a high-dose
capsaicin patch (Qutenza) <=30 days before the screening visit. - Moderate or strong cytochrome P450 inducer within 30 days before the screening visit. - Digoxin or prohibited medications that cannot be discontinued before randomization. - Other exclusions apply. [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia

The purpose of this study is to investigate whether NXN-462, a selective nNOS inhibitor, is
effective in reducing pain levels in patients with post-herpetic neuralgia.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Male, or a non-pregnant, non-lactating female 18 years or older

– Have voluntarily provided written informed consent

– able to speak, read, write, and understand English

– clinical diagnosis of PHN for a minimum of 6 months

– pain intensity score of ≥3 on a 0-10 Numerical Rating Scale (NRS) at the Screening
Visit

– generally in good health (other than PHN) at Screening

Exclusion Criteria:

– Are pregnant and/or lactating

– Diagnosis of any chronic pain syndrome that would interfere with the assessment of PHN

– evidence of multiple causes of neuropathic pain,e.g.lumbar radiculopathy in the
lumbosacral area

– Have had neuroablation or neurosurgical intervention for PHN

– Have been taking opioid analgesics for >5 days/week

– Have received nerve block or intrathecal analgesia within 6 weeks of the study

– History of significant gastrointestinal disease, liver disease, renal disease,
endocrine disease, or cardiovascular disease

– clinically significant abnormal clinical laboratory test results or vital signs

– Are immunocompromised or immunosuppressed for any reason

– History of alcohol or other substance abuse (not including nicotine or tobacco) within
5 years

– Significant psychiatric disorder which requires drug treatment (except depression or
anxiety treated with Selective Serotonin Re-uptake Inhibitors)

– Have received an investigational drug or have used an investigational device within 30
days of Screening.

– Have previously been randomized to this study

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain

This study is designed to investigate if pregabalin is effective in treating neuropathic
(nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such
as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia
repair, thoracotomy, mastectomy, focal/localized burns or crush injury.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Subjects must have chronic peripheral neuropathic pain present for than 6 months after
a traumatic or surgical event such as, for example, motor vehicle accident, fall,
sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy,
focal/localized burns or crush injury.

– Subjects must be literate and have the ability (unaided) to understand and use the
interactive voice response system (IVRS), have daily access to a telephone in order to
complete the IVRS assessments each day, perform telephone visits and complete all
required assessments/forms.

– Subjects must have sufficient post-traumatic neuropathic pain at screening and
baseline.

Exclusion Criteria:

– Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post
herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome
(CTS) or with central neuropathic pain (for example, due to spinal cord injury) or
with Complex Regional Pain Syndrome (CRPS, Type I or Type II).

– Subjects with other pain that may confound assessment or self-evaluation of the
peripheral neuropathic pain.

– Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate
course of therapy at doses greater than or equal to 150 mg/day, who have previously
participated in a pregabalin clinical trial or who have been treated with pregabalin
at any time during the 6 month period prior to screening.

– Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV
infection; any clinically unstable cardiovascular (including a myocardial infarction
[heart attack] in the 3 months prior to screening), hematological, autoimmune,
endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3
months prior to screening) respiratory, or gastrointestinal disease; symptomatic
peripheral vascular disease including intermittent claudication; uncontrolled diabetes
mellitus; untreated hypothyroidism.

– Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example,
schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder
(GAD) or major depression that is clinically stable.

– Subjects considered at risk of suicide or self-harm based on investigator judgment
and/or details of a risk assessment.

– Use of prohibited medications in the absence of appropriate washout periods.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20)

This is a prospective, multicenter, randomized, double-blind, placebo-controlled,
parallel-group 3-arm study to investigate 2 different doses of subcutaneous (SC) IgPro20
compared with placebo for maintenance treatment of patients with CIDP.

Patients who received at lease 1 dose of intravenous immunoglobulin (IVIG) within 8 weeks
before screening will be assessed during 4 separate study periods. Patients first undergo a
Screening Period, followed by an IgG Dependency Test Period of up to 12 weeks to test for
ongoing need of IgG. Those patients experiencing CIDP relapse during this test period will be
administered a standardized IVIG regimen during an IVIG Re-stabilization Period. Patients
with improved and maintained adjusted inflammatory neuropathy cause and treatment scale
(INCAT) in the IVIG Re-stabilization Period will continue to the SC Treatment Period of the
study. Patients entering the 24 week SC Treatment Period will be randomized to receive weekly
infusions of 1 of 2 IgPro20 doses (0.2 or 0.4 g/kg body weight) or placebo.

The overall study duration is up to 52 weeks. Clinical outcomes will be assessed by the
Inflammatory Neuropathy Cause and Treatment (INCAT) score, maximum grip strength, the Medical
Research Council (MRC) sum score, the Rasch-built Overall Disability Scale (R-ODS), and
electrophysiological evaluations.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Definite or probable CIDP according to the European Federation of Neurological
Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.

– An IVIG treatment during the last 8 weeks prior to enrollment.

– Age ≥18 years.

– Written informed consent for study participation obtained before undergoing any
study-specific procedures.

Exclusion Criteria:

– Any polyneuropathy of other causes

– Any other disease (mainly neurological or chronic orthopedic) that has caused
neurological symptoms or may interfere with treatment or outcome assessments

– Severe diseases and conditions that are likely to interfere with evaluation of the
study product or satisfactory conduct of the study

– History of thrombotic episodes within the 2 years prior to enrolment

– Known allergic or other severe reactions to blood products including intolerability to
previous IVIG

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Efficacy and Safety of DYSPORT® Using 2mL Dilution in Adults With Cervical Dystonia.

The purpose of the protocol is to evaluate the efficacy and safety of Dysport® using 2 mL
dilution compared with placebo for the treatment of Cervical Dystonia.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Primary diagnosis of Cervical Dystonia at least 9 months since onset and either
previously untreated with botulinum toxin or currently treated with Botox at a total
dosing range of 100-200 U and ≤60 U in the sternocleidomastoid muscle at the last
injection cycle, and having had a satisfactory treatment response in the principal
investigator’s judgment during the last two sequential Botox treatment cycles.

– TWSTRS total score≥ 20; TWSTRS-severity subscale score> 10;

Exclusion Criteria:

– In apparent remission from Cervical Dystonia

– Diagnosis of pure retrocollis or pure anterocollis

– For non-naïve subjects, previous poor response to either of the last two Botox
treatments

– Known requirement of <100U or >200U of Botox injected into the neck muscles

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin® in Subjects With Cervical Dystonia Flex

This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals
(Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the
response to treatment is comparable in both how it works and any side effects. Xeomin® is
approved by the United States Food and Drug Administration (FDA) for the treatment of
cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment
intervals. An investigational use is one that is not approved by the FDA.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Documented clinical diagnosis of idiopathic or genetic Cervical Dystonia

Exclusion Criteria:

– Current treatment with botulinum toxin of any type for any other indication (including
aesthetic indications) and for any body region during the study.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Long Term Safety And Effectiveness Of Dysport® In Adults With Cervical Dystonia

The purpose of the protocol is to assess the long term safety of repeat treatment cycles of
Dysport® 500 U using 2 mL dilution scheme for the treatment of Cervical Dystonia. This is an
extension study to study A-TL-52120-169 (hereafter referred to as Study 169).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Subjects enrolled in Study 169 that have no ongoing adverse events, which in the
opinion of the Investigator are related to study treatment and that precludes them
from receiving continuing therapy

– Completed Study 169, or completed all study visits up to and including Week 4 and in
the event of an early withdrawal after Week 4 have ≤15% reduction in TWSTRS total
score at Week 4 compared to their baseline TWSTRS total score in the double-blind
study, and in the Investigator’s clinical judgment, would benefit from Dysport® for CD

Exclusion Criteria:

– Diagnosis of pure retrocollis or pure anterocollis

– Requirement for Botulinum Neurotoxin (BoNT) injection to site(s) for disorders other
than CD and unable to avoid such treatment(s) for the duration of the study

– Known hypersensitivity to BoNT or related compounds, or any component in the study
drug formulation

– Allergy to cow’s milk protein

– Myasthenia gravis, other disease of the neuromuscular junction or clinically
significant, persistent neuromuscular weakness, or disease or symptoms that could
interfere with the TWSTRS scoring

– Total body weight <95 lbs (43.09 kg) - Previous phenol injections to the neck muscles - Previous myotomy or denervation surgery involving the neck or shoulder region or deep brain stimulation to treat CD - Cervical contracture that limited passive range of motion - Physiotherapy initiated <4 weeks before study entry or expected to be initiated during the study - Treatment with aminoglycoside antibiotics within 30 days prior to study treatment - Current or expected requirement for concomitant medication that could interfere with the evaluation of study treatment - Pregnant and/or lactating females - Females of childbearing potential with a positive prestudy urine pregnancy test (a positive urine pregnancy test could be confirmed by a serum pregnancy test at the discretion of the investigator) and subjects, or their partners, who did not agree to use adequate contraception (hormonal or barrier method of birth control) prior to injection of study treatment and for the duration of study participation. Nonchildbearing potential is defined as postmenopause for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy - Individuals who had family or employee relationship to study site staff or sponsor staff involved in the conduct of the study - Any medical condition that could, as judged by the investigator, compromise compliance with the objectives and procedures of this protocol or preclude the administration of BoNT, including swallowing and other respiratory abnormality. - Subjects who were unable and/or unwilling to comply fully with the protocol and the study instructions, as judged by the investigator [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative Participants

The primary objective of the study is to determine which baseline and yearly response factors
(clinical and para clinical) predict overall disease-free status at Month 12 and Month 24,
and clinical disease-free status in subsequent Months 36 and 48. The secondary objectives
are: To identify prognostic factors at Baseline that predict overall disease-free status at
Month 12, and to assess if yearly overall disease-free response factors predict overall
disease-free status at Month 24; To evaluate clinical disease-free status (relapse, Expanded
Disability Status Scale [EDSS]) at each analysis time point of Months 12, 24, 36, and 48; To
identify prognostic factors at Baseline that predict clinical disease-free status at Month
12, and to assess yearly clinical disease-free response factors that predict clinical
disease-free status (relapse, EDSS) in subsequent years at Months 24, 36, and 48; To evaluate
the impact of Tysabri at each analysis time point of Months 12, 24, 36, and 48 on the
following: annualized relapse rate (ARR), sustained EDSS progression and improvement (24-week
sustained); To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,
36, and 48 on the following: magnetic resonance image (MRI) measures: T2, T1, T1 with
Gadolinium (Gd), brain atrophy; To evaluate the impact of Tysabri at Month 24 and Month 48 on
the following: optical coherence tomography (OCT), Low and High Contrast Visual Acuity
Assessment; To evaluate the impact of Tysabri at each analysis time point of Months 12, 24,
36, and 48 on the following: cognitive impairment (Symbol Digit Modalities Test [SDMT]),
capacity for work (Work Productivity and Activity Impairment Questionnaire [WPAI]), quality
of life (QoL) (Multiple Sclerosis Impact Scale [MSIS-29])

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Key Inclusion Criteria:

– Documented diagnosis of Relapsing Multiple Sclerosis (McDonald 2010 Criteria ).

– <3 year disease duration. - Must have an Expanded Disability Status Scale (EDSS) score from 0 to 4.0, inclusive. - Anti-JCV antibody negative test within 6 months of Screening Visit. - Must satisfy the approved therapeutic indications for Tysabri. - Must be treatment-naïve to disease-modifying therapy (DMT) or have been treated with DMT (including but not limited to Avonex, Betaseron, Rebif, Copaxone, Extavia, or Gilenya) for ≤36 months total prior to date of informed consent. - Decision to treat with Tysabri must precede enrollment. Key Exclusion Criteria: - Any prior treatment with Tysabri. - Anti-JCV antibody positive at any timepoint prior to the Screening Visit. - Contraindications to treatment with Tysabri as described in the US Prescribing Information. - History of progressive multifocal leukoencephalopathy (PML) or other opportunistic infections, or an increased risk for such infections. - History of diagnosis of Primary Progressive Multiple Sclerosis (PPM) and/or Secondary Progressive Multiple Sclerosis (SPMS). - Receiving immunomodulatory or immunosuppressive therapy. - Prior history of immunosuppressive use (mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab). - Immunocompromised at the time of enrollment. - Known active malignancies (subjects with cutaneous basal cell carcinoma that has been completely excised prior to study entry remain eligible). - Women breastfeeding, pregnant, or planning to become pregnant; women who are not post-menopausal or surgically sterile who are unwilling to practice contraception. - Inability to comply with study requirements. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Safety and Efficacy Study of OnabotulinumtoxinA for the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity (NDO) in Non-Catheterizing Patients With Multiple Sclerosis (MS)

This study will evaluate the safety and efficacy of OnabotulinumtoxinA (BOTOX®) for the
treatment of urinary incontinence due to NDO in non-catheterizing patients with MS.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– At least 3 episodes of urinary incontinence over a 3-day period

– History of Multiple Sclerosis (MS)

– Urinary incontinence not adequately controlled by anticholinergic medication

Exclusion Criteria:

– Current use of intermittent catheter or indwelling catheter to manage urinary
incontinence

– Previous or current botulinum toxin therapy of any serotype for any urological
condition

– Previous or current botulinum toxin therapy of any serotype for any non-urological
condition within the last 12 weeks

– Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, or Amyotrophic Lateral
Sclerosis

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

The purpose of this study was to demonstrate that at least one dose (0.5 mg followed by 0.25
mg) of fingolimod is superior to glatiramer acetate 20 mg SC in reducing the ARR up to 12
months in patients with relapsing-remitting MS

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion criteria:

– Written informed consent must be obtained before any assessment is performed

– Male and female patients 18 to 65 years of age, inclusive.

– Patients with RRMS, as defined by 2010 revised McDonald criteria.

– Patients must be neurologically stable with no onset of relapse within 30 days of
randomization

– Patients with at least 1 documented relapse during the previous year or 2 documented
relapses during the previous 2 years before randomization.

– Patients with an EDSS score of 0 to 6, inclusive, at Screening. A score of 6.0
indicates unilateral assistance (cane or crutch) required to walk at least 100 meters
with or without resting.

Exclusion criteria:

– Patients with a history of malignancy of any organ system (other than cutaneous basal
cell carcinoma) in the last 5 years that do not have confirmation of absence of a
malignancy prior to randomization

– Patients with an active chronic disease (or stable but treated with immune therapy) of
the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren’s
syndrome, Crohn’s disease, ulcerative colitis) or with a known immunodeficiency
syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced
immune deficiency).

– Patients who have been treated with:

– High-dose intravenous (IV) immunoglobulin (Ig) within 4 weeks before randomization

– Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide,
methotrexate) within 6 months before randomization

– Natalizumab within 2 months before randomization

– Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab,
ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous
treatment with mitoxantrone within 6 months before randomization

– Use of teriflunomide within 3.5 months prior to randomization, except if active
washout (with either cholestyramine or activated charcoal) was done. In that case,
plasma levels are required to be measured and be below 0.02 mg/L before randomization.

No washout period is necessary for patients treated with dimethyl fumarate, interferon
(IFN) beta, or glatiramer acetate.

Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the
Screening visit can continue drug intake up to the day before Day 1 of this study (i.e.,
there is no need for a washout period).

– Patients who have been treated with systemic corticosteroids or adrenocorticotropic
hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI)
procedure.

– Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin >9%) or with
diabetic neuropathy.

– Patients with a diagnosis of macular edema during Screening (patients with a history
of macular edema will be allowed to enter the study provided that they do not have
macular edema at Screening).

– Patients with severe active bacterial, viral, or fungal infections.

– Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at
randomization.

– Patients who have received any live or live-attenuated vaccines (including VZV, herpes
simplex, or measles) within 1 month before randomization.

– Patients who have received total lymphoid irradiation or bone marrow transplantation.

– Patients with any unstable medical/psychiatric condition, as assessed by the primary
treating physician at each site.

– Patients who in the last 6 months experienced any of the following cardiovascular
conditions or findings in the screening electrocardiogram (ECG): myocardial
infarction, unstable angina, stroke, transient ischemic attack or decompensated heart
failure requiring hospitalization or Class III/IV heart failure.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Glatiramer Acetate for Multiple Sclerosis With Autoimmune Comorbidities

The incidence of autoimmune conditions is at least 2-3 times higher in Multiple Sclerosis
population than in general population. These MS patients category response unfavorably to the
Interferon. The investigators suggest that autoimmune co morbidity can serve as a biological
marker predicting good response to GA.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Clinically definite multiple sclerosis defined by McDonald Criteria.

– Between 18-60 years of age.

– Subject must able to understand and sign the IRB- approved informed consent form prior
to the performance of any study-specific procedures and is willing to comply with the
required scheduling and assessments of the protocol.

– Subjects who are women of childbearing potential, must have a negative serum pregnancy
test at the screening visit, and must be willing to practice a reliable birth-control
method.

– Subjects must have officially diagnosed and documented co-morbid, other than MS,
autoimmune condition (psoriasis, vasculitis, thyroiditis or rheumatoid arthritis).

– At the time of enrollment patients were on beta IFN (Avonex, Betaseron or Rebif)
treatment for at least 3 months.

Exclusion Criteria:

– Women who are either pregnant or breastfeeding, and women of child-bearing potential
(defined as not surgically sterile or at least two years postmenopausal) who are not
using one of the following birth control methods: tubal ligation, implantable
contraception device, oral, patch, injectable or transdermal contraceptive, barrier
method or sexual activity restricted to vasectomized partner.

– Any clinically significant general health conditions that may interfere with the trial
participation.

– Subject has a history of drug or alcohol abuse within the past year.

– Subject had corticosteroid treatment within last 90 days.

– Subject started new medication within last 30 days.

– Subject is a participant in another research project.

– Subject has contraindications for GA treatment.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors

This randomized phase II trial studies how well pazopanib hydrochloride works in treating
patients with carcinoid tumors that are growing, spreading, or getting worse. Pazopanib
hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for
cell growth.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes:
carcinoid tumor, low- to intermediate-grade or well- to moderately-differentiated
neuroendocrine carcinoma or tumor, atypical carcinoid tumor; documentation from a
primary tumor or metastatic site is sufficient; patients with poorly differentiated
neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor,
or goblet cell carcinoid tumor are not eligible

– Locally unresectable or metastatic carcinoid tumors

– Patients must have histologic documentation or clinical evidence of a carcinoid tumor
of primary site (including foregut, midgut, hindgut or other non-pancreatic site);
tumors of unknown primary site are eligible provided the treating physician does not
suspect medullary thyroid cancer, pancreatic neuroendocrine tumor, paraganglioma, or
pheochromocytoma; unknown primary tumors will be classified as small bowel tumors for
the purpose of stratification; functional (associated with a clinical syndrome) or
nonfunctional tumors are allowed; target lesions must have shown disease progression
if therapy included peptide receptor radiotherapy (PRRT) and PRRT must be completed at
least 8 weeks prior to registration

– Radiological evidence for progressive disease (measurable or non-measurable) within 12
months prior to registration; patients who have received anti-tumor therapy during the
past 12 months (including octreotide analogs) must have had radiological documentation
of progression of disease while on or after receiving therapy

– No known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
that increase the risk of pulmonary hemorrhage; patients with lesions infiltrating
major pulmonary vessels (contiguous tumor and vessels) are excluded; however, the
presence of a tumor that is touching, but not infiltrating (abutting) the vessels is
acceptable (computed tomography [CT] with contrast is strongly recommended to evaluate
such lesions); patients with large protruding endobronchial lesions in the main or
lobar bronchi are excluded; however, endobronchial lesions in the segmented bronchi
are allowed

– Patients must have measurable disease per RECIST 1.1 by computed tomography (CT) scan
or magnetic resonance imaging (MRI); lesions must be accurately measured in at least
one dimension (longest diameter to be recorded) as >= 1 cm with CT or MRI (or >= 1.5
cm for lymph nodes); index lesions for the purpose of RECIST 1.1 measurements will not
be selected from within the radiation therapy treatment field; however, if there is
evidence of disease progression within the radiation treatment field, measurement of
the progressing lesions will be documented

– No prior treatment with an inhibitor of vascular endothelial growth factor (VEGF) or
vascular endothelial growth factor receptor (VEGFR)

– Prior treatment (somatostatin analogs excepted) must be completed at least 2 weeks
prior to registration; in addition, prior treatment (somatostatin analogs excepted)
must be completed at least 4 weeks prior to initiation of study drug;
treatment-related toxicities must have improved to =< grade 1 prior to registration, with the exception of alopecia - Concurrent use of somatostatin analogs (SSTa) is allowed, provided that the patient is on a stable dose for at least two months and progressive disease on somatostatin analog has been documented; progression on octreotide is required for patients with tumors arising in the midgut - Prior treatment with embolization (including bland embolization, chemoembolization, and selective internal radiation therapy) or ablative therapies is allowed if measurable disease remains outside of the treated area or there is documented disease progression in a treated site; there is no limit on the prior number of procedures; prior liver-directed or other ablative treatment must be completed at least 8 weeks prior to registration; index lesions for the purpose of RECIST 1.1 measurements will not be selected from within the radiation therapy treatment field; however, if there is evidence of disease progression within the radiation treatment field, measurement of the progressing lesions will be documented - Patients should have completed any major surgery >= 4 weeks prior to registration and
must have completed any minor surgery >= 2 weeks prior to registration; patients must
have fully recovered from the procedure

– The following are examples of procedures considered to be minor: port placement,
laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, skin biopsies,
incisional biopsies, imaging-guided biopsy for diagnostic purposes, and dental
extraction procedures

– Insertion of a vascular access device, thoracentesis, paracentesis, and
endoscopic ultrasonographic procedures are not considered to be major or minor
surgeries

– No concurrent condition resulting in immune compromise, including chronic treatment
with corticosteroids or other immunosuppressive agents

– No clinical evidence of central nervous system (CNS) metastases (including
carcinomatous meningitis) at baseline, with the exception of those patients who have
previously-treated CNS metastases (surgery +/- radiotherapy, radiosurgery, or gamma
knife) and who meet both of the following criteria: a) are asymptomatic and b) had no
requirement for steroids or enzyme-inducing anticonvulsants within 6 months prior to
registration

– No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 28 days prior to registration

– No clinically significant gastrointestinal abnormalities that may increase the risk
for gastrointestinal bleeding within 28 days prior to registration including, but not
limited to:

– Active peptic ulcer

– Known endoluminal metastatic lesion(s) with history of bleeding

– Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other
gastrointestinal conditions with increased risk of perforation

– No history of serious (i.e., requiring active medical therapy with medication or
medical device under the supervision of a physician) non-healing wound, ulcer, trauma,
or bone fracture within 28 days prior to study entry

– Patients with a history of hypertension must have blood pressure that is adequately
controlled on antihypertensives; (< 140/90 mm Hg) - No symptomatic congestive heart failure (New York Heart Association class II, III, or IV) within 6 months prior to registration - No arterial thrombotic events within 6 months of registration, including transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral arterial thrombus, myocardial infarction (MI), or unstable angina or angina requiring surgical or medical intervention in 6 months prior to registration; patients with clinically significant peripheral artery disease (i.e., claudication on less than one block) are ineligible; patients who have experienced a deep venous thrombosis or pulmonary embolus within 6 months prior to registration must be on stable therapeutic anticoagulation for at least 6 weeks prior to enrollment of this study - Patients on therapeutic anticoagulation with low molecular weight heparins, fondaparinux, rivaroxaban or warfarin are eligible, provided that they are on a stable dose of anticoagulants; patients who are currently receiving antiplatelet therapy of prasugrel or clopidogrel or antiaggregation agents (e.g., eptifibatide, epoprostenol, dipyridamole) or low doses of acetylsalicylic acid (up to 100 mg daily) are also eligible - No ongoing cardiac dysrhythmias, atrial fibrillation, or prolongation of corrected QT (QTc) interval to > 480 msec

– No evidence of active bleeding, bleeding diathesis, or hemoptysis (>= 1/2 teaspoon of
red blood) within 8 weeks prior to registration

– No currently unstable angina and/or uncontrolled cardiac arrhythmias

– Patients with symptomatic peripheral vascular disease are ineligible

– Ejection fraction on echocardiogram (Echo) or multi gated acquisition scan (MUGA) >
50%

– Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3,
subfamily A, polypeptide 4 (CYP3A4) is not allowed on this trial; patients on strong
CYP3A4 inhibitors must discontinue the drug 14 days prior to the start of study
treatment

– Women must not be pregnant or nursing; women of child bearing potential must have a
negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent
units of human chorionic gonadotropin [HCG]) within 72 hours prior to registration;
women of child-bearing potential include any female who has experienced menarche and
who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation
or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea >= 12
consecutive months; or women on hormone replacement therapy [HRT] with documented
serum follicle stimulating hormone [FSH] level > 35 mIU/mL)

– Eastern Cooperative Oncology Group (ECOG) performance status 0-1

– Granulocytes >= 1,500/mcL

– Platelets >= 100,000/mcL

– International normalized ratio (INR) =< 1.2 X upper limit of normal (ULN); only required for patients receiving anticoagulant therapy; patients are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation - QTc =< 480 msecs - Thyroid stimulating hormone (TSH) within normal limits (WNL); medications for thyroid dysfunction are allowed as long as TSH is normal at registration; in patients with abnormal TSH, if the free thyroxine (free T4) and free thyroxine index (FTI) are normal and patient is clinically euthyroid, patient is eligible - Bilirubin =< 1.5 x ULN - Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) & alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN; concomitant elevations in bilirubin and AST/ALT above 1.0 X ULN are NOT permitted; also, if liver metastases are present, AST & ALT =< 5 x ULN is allowed - Serum creatinine =< 1.5 x ULN - Urine protein to creatinine ratio < 1, or, 24-hour urine protein < 1 g; if urine protein to creatinine (UPC) >= 1, then a 24-hour urine protein must be assessed;
patients must have a 24-hour urine protein value < 1 g to be eligible; use of urine dipstick for renal function assessment is not acceptable [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or
standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after
prior therapy.

Initial Treatment Period:

Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab,
higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four
standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine,
or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an
open-label fashion.

The starting pembrolizumab dose was initially blinded to Investigators and participants until
Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated
with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of
pembrolizumab.

Switch-to-Pembrolizumab Treatment Period:

Participants who were initially randomized to receive ICC and experienced progressive disease
(PD) may have been eligible to switch to receiving pembrolizumab provided they met
protocol-specified requirements for switching. Qualified participants were re-randomized to
receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion.
Participants who qualified to switch to pembrolizumab must have completed a washout period of
≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03,
all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose
pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Histologically or cytologically confirmed diagnosis of unresectable Stage III or
metastatic MEL not amenable to local therapy

– Participants must be refractory to ipilimumab

– Participants with BRAF gene mutant melanoma must have had a prior treatment regimen
that included vemurafenib, dabrafenib, or an approved BRAF gene and/or
mitogen-activated protein kinase (MEK) protein inhibitor

– Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy
specimen (or specimen obtained within 60 days of consenting)

– Radiographically measurable disease

– Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

– Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to
the first dose of study drug, or not recovered from the AEs due to cancer therapies
administered more than 4 weeks earlier

– Disease progression within 24 weeks of last dose of ipilimumab

– Participating or has participated in a study of an investigational agent or using an
investigational device within 30 days of the first dose of study drug

– Expected to require any other form of systemic or localized antineoplastic therapy
while on study

– Chronic systemic steroid therapy within 2 weeks before the planned date for first dose
randomized treatment or on any other form of immunosuppressive medication

– Known history of any other than the current malignancy excepting adequately treated
basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ
cervical cancer, breast cancer, or other in situ cancers

– Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

– Active autoimmune disease or a history of autoimmune disease or syndrome that requires
systemic steroids or immunosuppressive agents

– Prior treatment with any other anti-programmed cell death (PD) agent

– Active infection requiring systemic therapy

– Known history of Human Immunodeficiency Virus (HIV)

– Active Hepatitis B or Hepatitis C

– Regular user (including recreational use of) illicit drugs or had a recent history
(within the last year) of substance abuse (including alcohol)

– Pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the study through 120 days after last dose of study drug

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

The purpose of this study is to compare the antitumor activity of everolimus plus best
supportive care versus placebo plus best supportive care in patients with advanced
nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or
metastatic), neuroendocrine tumor of GI or lung origin

– No history of and no active symptoms related to carcinoid syndrome

– In addition to treatment-naive patients, patients previously treated with SSA,
Interferon (IFN), one prior line of chemotherapy, and/or PRRT are allowed into the
study. Pretreated patients must have progressed on or after the last treatment

– Radiological documented disease progression within 6 months prior to randomization

– Measurable disease

– WHO performance status ≤1

– Adequate bone marrow, liver and renal function

Exclusion Criteria:

– Patients with poorly differentiated neuroendocrine carcinoma, high-grade
neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma,
glucagonoma, gastrinoma, goblet cell carcinoid, large cell neuroendocrine carcinoma
and small cell carcinoma

– Patients with pancreatic NET or NET of origins other than GI or Lung

– Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing,
diarrhea)

– Patients with more than one line of prior chemotherapy

– Prior targeted therapy

– Hepatic locoregional therapy within the last 6 months

– Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus)

– Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g.
sirolimus, temsirolimus)

– Known impairment of gastrointestinal (GI) function or GI disease that may
significantly alter the absorption of oral everolimus

– Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy

– Patients who have any severe and/or uncontrolled medical conditions such as:

– unstable angina pectoris, symptomatic congestive heart failure, myocardial
infarction ≤6 months prior to randomization, serious uncontrolled cardiac
arrhythmia

– active or uncontrolled severe infection

– liver disease such as cirrhosis, decompensated liver disease, and chronic
hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA)

– Chronic treatment with corticosteroids or other immunosuppressive agents

– Known history of HIV seropositivity

– Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Study to Compare the Effect of Ipilimumab Retreatment With That of Chemotherapy in Advanced Melanoma

The purpose of the study is to determine whether additional doses of ipilimumab have a
positive effect on survival in the treatment of advanced melanoma that has progressed after
successful initial treatment with ipilimumab.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.

Key Inclusion Criteria:

– Histologic diagnosis of unresectable stage III or IV metastatic melanoma

– Prior ipilimumab induction treatment (3 mg/kg)

– Documented disease control [Stable Disease ≥3 months or Partial Response/Complete
Response] after ipilimumab induction

– Documented progressive disease following disease control

Key Exclusion Criteria:

– Patients with brain metastasis are excluded, unless they are free of neurologic
symptoms related to metastatic brain lesions and do not receive systemic
corticosteroid therapy for the purpose of reducing intracranial inflammation in the 10
days prior to beginning retreatment with ipilimumab

– Any intervening anticancer therapy between last dose of ipilimumab induction and
ipilimumab retreatment on study

– Patients who experienced any grade 3 immune-related adverse event (irAE) (except for
endocrinopathies where clinical symptoms were controlled with appropriate hormone
replacement therapy) or any grade 4 toxicity during prior treatment with ipilimumab

– Patients with a prior irAE that has not improved to grade 1 or better at randomization

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group
study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral
capsules, an extended release formulation of amantadine, dosed once daily for the treatment
of levodopa-induced dyskinesia (LID) in subjects with Parkinson’s disease (PD). The novel
pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma
concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms
of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may
reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and
iii) a reduced initial rate of rise in plasma concentration, which is expected to improve
overall tolerability of amantadine.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Signed a current IRB/IEC-approved informed consent form

– Parkinson’s disease, per UK Parkinson’s Disease Society (UKPDS) Brain Bank Clinical
Diagnostic Criteria

– On a stable regimen of antiparkinson’s medications , including any levodopa
preparation administered not less than three times daily, and willing to continue the
same doses and regimens during study participation

– Experiencing troublesome dyskinesia following levodopa dosing (peak dose dyskinesia)

– Able to understand and complete a standardized PD home diary, following training

Exclusion Criteria:

– History of neurosurgical intervention related to Parkinson’s disease (e.g. deep brain
stimulation)

– History of seizures or stroke/TIA within 2 years of screening

– History of cancer within 5 years of screening, except adequately treated
non-melanomatous skin cancers, localized bladder cancer, non-metastatic prostate
cancer or in situ cervical cancer

– Estimated GFR < 50 mL/min/1.73m2 - Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening - If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose - If a sexually active female, is not surgically sterile or at least 2 years post-menopausal, or does not agree to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment - Treatment with an investigational drug or device within 30 days prior to screening - Treatment with an investigational biologic within 6 months prior to screening [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa Therapy

Evaluate the clinical efficacy and safety of droxidopa versus placebo over a 17 week
(maximum) treatment period in patients with symptomatic NOH.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– 1. 18 years and older and ambulatory (defined as able to walk at least 10 meters);

2. Clinical diagnosis of symptomatic orthostatic hypotension associated with Primary
Autonomic Failure (PD, MSA and PAF), Dopamine Beta Hydroxylase Deficiency;

3. At the Baseline visit (Visit 2), patients must demonstrate:

1. a score of at least 4 or greater on the Orthostatic Hypotension Symptom
Assessment (OHSA) Item #1;

2. a fall of at least 20 mmHg in their systolic blood pressure, within 3 minutes of
standing;

4. Provide written informed consent to participate in the study and understand
that they may withdraw their consent at any time without prejudice to their
future medical care;

Exclusion Criteria:

– 1. Score of 23 or lower on the mini-mental state examination (MMSE);

2. Concomitant use of vasoconstricting agents for the purpose of increasing blood
pressure;

1. Patients taking vasoconstricting agents such as ephedrine, dihydroergotamine, or
midodrine must stop taking these drugs at least 2 days or 5 half-lives (whichever
is longer) prior to their baseline visit (Visit 2) and throughout the duration of
the study;

3. Known or suspected alcohol or substance abuse within the past 12 months
(DSM-IV definition of alcohol or substance abuse);

4. Women who are pregnant or breastfeeding;

5. Women of child bearing potential (WOCP) who are not using at least one method
of contraception with their partner;

6. Male patients who are sexually active with a woman of child bearing potential
(WOCP) and not using at least one method of contraception;

7. Untreated closed angle glaucoma;

8. Diagnosis of hypertension that requires treatment with antihypertensive
medications (short-acting antihypertensives to treat nocturnal supine HTN are
allowed in this study) Any significant uncontrolled cardiac arrhythmia;

9. History of myocardial infarction, within the past 2 years;

10. Current unstable angina;

11. Congestive heart failure (NYHA Class 3 or 4);

12. History of cancer within the past 2 years other than a successfully treated,
non-metastatic cutaneous squamous cell or basal cell carcinoma or cervical cancer
in situ;

13. Gastrointestinal condition that may affect the absorption of study drug (e.g.
ulcerative colitis, gastric bypass);

14. Any major surgical procedure within 30 days prior to the Baseline visit
(Visit 2);

15. Previously treated with droxidopa within 30 days prior to the Baseline visit
(Visit 2);

16. Currently receiving any other investigational drug or have received an
investigational drug within 30 days prior to the Baseline visit (Visit 2);

17. Any condition or laboratory test result, which in the Investigator’s
judgment, might result in an increased risk to the patient, or would affect their
participation in the study;

18. The Investigator has the ability to exclude a patient if for any reason they
feel the subject is not a good candidate for the study or will not be able to
follow study procedures.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Safety and Efficacy Study of SYN115 in Parkinson’s Patients Using Levodopa to Treat End of Dose Wearing Off

The purpose of this research study is to test the effect of SYN115 compared to placebo (a
“sugar pill” that looks like SYN115 but does not include active drug) on movement during the
“on” and “off” states as well as other symptoms that some patients with Parkinson’s disease
experience. This study will also look at whether or not patients with Parkinson’s disease
experience “side-effects” with SYN115.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Meet Parkinson’s Disease (PD) diagnosis consistent with UK PD diagnostic criteria

– Meet Hoehn and Yahr PD stage

– Good response to levodopa

– Stable regimen of anti-parkinson medications

– Are able to complete a Parkinson’s disease diary

– If of childbearing potential(male and female), use an acceptable method of birth
control

– Able and willing to sign an IRB/IEC approved informed consent

– Able and willing to understand study requirements, follow study instructions, attend
all visits and undergo all planned tests.

Exclusion Criteria:

– Secondary or atypical Parkinson’s

– Neurosurgical intervention for Parkinson’s disease

– Treatment with apomorphine

– Treatment with anti-psychotic drugs

– Other abnormal findings on physical or neuro exam or history that in the opinion of
the investigator would make subject unsuitable for the study or prejudice safety and
efficacy evaluation

– MMSE less than 26

– Subjects with untreated or uncontrolled current episode of major depression

– Receipt of any anti-psychotic drugs greater than 1 month in the past 5 years or any
exposure in past year (except for quetiapine at doses <100mg per day) - Women pregnant or lactating - History of hepatitis, cholangitis - Untreated or uncontrolled hypothyroidism or hyperthyroidism - Drops in blood pressure requiring medication to maintain blood pressure - Any clinically significant out of range laboratory evaluations - Known sensitivity to the study medication or its components - Suicide ideation or type 4 or type 5 on the Columbia suicide severity rating scale - Finding of malignant melanoma on full body skin exam - Impulse disorder conditions [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Disease-modifying Potential of Transdermal NICotine in Early Parkinson’s Disease

The primary objective of this study is to demonstrate that transdermal nicotine treatment
retards disease progression as measured by change in total Unified Parkinson’s Disease Rating
Scale (UPDRS)(part I, II, III)score between baseline and after 52 weeks of study treatment
plus two more months wash out (60 weeks).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

1. Written informed consent

2. Capability and willingness to comply with the study related procedures

3. Age >/= 30 y

4. Usage of effective contraception (see below) in fertile pre-menopausal female
participants (from inclusion until end of wash out) Acceptable forms of effective
contraception include established use of oral, injected or implanted hormonal methods
of contraception, placement of an intrauterine device (IUD) or intrauterine system
(IUS), barrier methods of contraception (condom or occlusive cap /diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/suppository or male / female
sterilization / or true abstinence.

5. Diagnosis of PD according to the UK Brain Bank Diagnostic Criteria

6. Early PD subjects within 18 months of diagnosis

7. Hoehn and Yahr stage ≤ 2

8. Patients not receiving or needing dopamine agonist or levodopa therapy presently or
for the next year

9. Stable treatment (>2 months) with MAO-B inhibitor (selegiline up to 10 mg/d or
rasagiline up to 1 mg/d) allowable

Exclusion Criteria:

1. Clinical signs indicating a Parkinson syndrome other than idiopathic PD e.g.:

– Supranuclear gaze palsy

– Signs of frontal dementia

– History of repeated strokes with stepwise progression of Parkinsonian features

– History of repeated head injury or history of definite encephalitis

– Cerebellar signs

– Early severe autonomic involvement

– Babinski’s sign

2. History of exposure to or current treatment with neuroleptic drugs or anticraving
substances

3. History of nicotine use within five years of the baseline visit

4. Previous history of allergic response to nicotine application or any of the patch
excipients (see protocol sec. 10.2)

5. Previous history of allergic response to transdermal patches

6. Pre-existing dermatological disorder that could disturb transdermal patch application
in the opinion of the investigator (e.g. generalized / systemic or local
neurodermatitis, psoriasis, chronic dermatitis, urticaria, etc.)

7. Previous treatment with antiparkinsonian drugs (e.g. levodopa, dopamine agonists,
etc.) other than MAO-B inhibitors

8. History of unstable or serious cardiovascular diseases

– Unstable or worsening angina pectoris,

– History of recent myocardial infarction or cardiac failure (NYHA from II to IV),
myocardial insufficiency

– History at inclusion of serious cardiac arrhythmia,

– History of recent stroke or occlusive peripheral vascular disease, vasospasm

9. History of structural brain disease, cerebrovascular diseases

10. History of severe uncontrolled arterial hypertension

11. History of severe pulmonary disease (asthma, COPD)

12. History of auto-immune disease

13. History of Hyperthyroidism

14. History of Pheochromocytoma

15. History of seizures / epilepsy

16. History of amyosthenia / myasthenia gravis, pseudo-myasthenic syndrome

17. Dementia defined as Mini Mental State Examination (MMSE) score ≤ 24

18. Moderate depression (BDI-II score >24)

19. Suicide or suicide ideation

20. History or presence of specific psychiatric disorders, acute psychosis,
hallucinations, pathologic gambling, alcohol or substance abuse

21. Patients under treatment with dihydropyridines (e.g. nifedipine, nicardipine,
amlodipine)

22. History of uncontrolled diabetes

23. History of recent gastroduodenal ulcer (< 3 months) or presence of severe (acute and chronic) gastritis 24. History of known hepatobiliary or renal insufficiency 25. Pregnancy or lactation period 26. Simultaneous participation or previous participation within 60 days before screening in another clinical drug or medical device study. Other Trials that do not affect the NIC-PD Study (NIT, health economics evaluations, questionnaires, genetic studies) could be allowed, but have to be approved and documented by the steering committee [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson’s Disease

This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and
rasagiline for the treatment of early Parkinson’s disease.

Animal studies support the therapeutic advantage of combining low doses of rasagiline and
pramipexole and suggest further improvement when both are administered in a sustained
fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson’s
disease with a good safety profile. combining the drugs in low doses and controlled release
may provide better symptom management than the existing drugs alone or together.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Subject is male or female ≥35 years of age to ≤75 years of age at the time of
enrollment.

– Subject has idiopathic Parkinson’s disease consistent with the UK Brain Bank Criteria;
must have bradykinesia with sequence effect and rest tremor or prominent motor
asymmetry.

– Subject with disease duration no longer than 3 years and 0 months.

– Subject has a Hoehn & Yahr (H&Y) stage score of < 3. - Subject has a MMSE score ≥ 26 Exclusion Criteria: - Subject has an atypical parkinsonian syndrome or secondary parkinsonism (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease). - Subject has a history of psychosis or hallucinations within the previous 12 months. - Subject who is taking anticholinergic drugs. - Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit. - Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit. - Subject who is taking MAO inhibitors, potent CYP1A2 inhibitors, e,g, Ciprofloxacin, Dextromethorphan or antitussive agent, analgesic agents such as tramadol, meperidine, methadone and propoxyphene, strong 3A4 inducers, e.g., St. John's Wort or cyclobenzaprine (tricyclic muscle relaxant), dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide. Probenecid, cimetidine, ranitidine, diltiazem, verapamil and quinidine. [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

A Long-Term Safety Extension of Studies ABE4869g and ABE4955g in Participants With Mild to Moderate Alzheimer’s Disease Treated With Crenezumab

This Phase II, open-label extension (OLE), multicenter study will evaluate the long-term
safety and tolerability of crenezumab in participants with mild to moderate Alzheimer’s
disease who have participated in and completed the treatment period of the Phase II Study
ABE4869g (NCT01343966) or ABE4955g (NCT01397578). Participants who received placebo in Study
ABE4869g (NCT01343966) or ABE4955g (NCT01397578) will receive crenezumab. Anticipated time on
study treatment is 144 weeks.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Previous participation in Study ABE4869g or ABE4955g and completion of the Week 73
visit

– Adequate visual and auditory acuity, in the investigator’s judgment, to allow for
neuropsychological testing

– Availability of a person (“caregiver”) who can provide information on activities of
daily living and behavior in order to complete the study-specific assessments

– Diagnosis of probable Alzheimer’s disease according to the National Institute on
Neurological and Communication Disease and Stroke/Alzheimer’s Disease and Related
Disorders Association (NINCDS-ADRDA) criteria (McKhann et al. 1984)

– Mini-Mental State Examination (MMSE) score of 10 or more at screening (Folstein et al.
1975)

– For male participants with partners with reproductive potential, agreement to use a
reliable means of contraception (e.g., condoms) during the study and for at least 8
weeks following the last dose of study drug

– For female participants, a negative pregnancy test at screening

Exclusion Criteria:

– Early treatment and/or study discontinuation prior to completion of the Week 73 visit
of Genentech Study ABE4869g or ABE4955g

– Early discontinuation from the treatment schedule of a prior version of Study GN28525
for safety reasons. If treatment discontinuation occurred for safety reasons,
participants may not re-start dosing on extended treatment schedules offered in
amendments to Study GN28525

– Inability to tolerate Magnetic Resonance Imaging (MRI) procedures or contraindication
to MRI

– Female participants with reproductive potential: Female participants must either have
undergone documented surgical sterilization or have not experienced menstruation for
at least 12 consecutive months

– Severe or unstable medical condition that, in the opinion of the investigator or
Sponsor, would interfere with the participant’s ability to complete the study
assessments or would require the equivalent of institutional or hospital care

– History or presence of clinically evident vascular disease potentially affecting the
brain

– History of severe, clinically significant central nervous system trauma

– History or presence of clinically relevant intracranial tumor

– Presence of infections that affect the brain function or history of infections that
resulted in neurologic sequelae

– History or presence of systemic autoimmune disorders potentially causing progressive
neurologic disease

– History or presence of a neurologic disease other than Alzheimer’s disease that may
affect cognition

– History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric, human, or humanized antibodies or fusion proteins

– Evidence of malignancies (except squamous cell cancer or basal cell cancer of the
skin), acute infections, renal failure that requires dialysis, or other unstable
medical disease not related to Alzheimer’s disease that, in the investigator’s
opinion, would preclude participant’s participation. Cancer that is not being actively
treated with anti-cancer therapy or radiotherapy as well as cancers which are
considered to have low probability of recurrence are allowed

– History or presence of atrial fibrillation that, in the investigator’s judgment, poses
a risk for future stroke

– Chronic kidney disease of Stage greater than or equal to (>=) 4, according to the
National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI)
guidelines for chronic kidney disease (CKD)

– Impaired hepatic function

– Impaired coagulation (activated partial thromboplastin time [aPTT] greater than [>] 1.2 times upper limit of normal [ULN])

– Platelet count less than (<) 100,000 per microliter (mcL) - Presence at screening of superficial siderosis of central nervous system, more than 8 cerebral microhemorrhages, or evidence of a prior cerebral macrohemorrhage - Presence at screening of any other significant cerebral abnormalities, including ARIA-E - Treatment with anticoagulation medications within 2 weeks prior to enrollment. Clopidogrel, dipyridamole, and aspirin are permitted - Treatment with anticholinergic antidepressants, typical antipsychotics, or barbiturates within 2 weeks prior to enrollment. All other antidepressants and atypical antipsychotics are allowed with certain restrictions as defined in the protocol - Chronic use of opiates, opioids, or benzodiazepines - Any biologic therapy within 75 weeks prior to enrollment - Any investigational agent (other than crenezumab) within 75 weeks prior to enrollment - Treatment with anticholinergic antidepressants, typical antipsychotics, barbiturates, or narcotics within 5 half-lives or 3 months prior to screening, whichever is longer. All other antidepressants and atypical antipsychotics are allowed. Chronic use of benzodiazepines is not allowed; however, the intermittent use of benzodiazepines is allowed, except within 2 days prior to any neurocognitive assessment [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Imaging of Brain Amyloid Plaques in the Aging Population

This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of
this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to
ascertain the relationship between change in amyloid burden over time, and concurrent change
in clinical status.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Age 30-100

– Subjects who have completed or are scheduled to undergo the neurological evaluation
procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative
disease clinics.

Exclusion Criteria:

– Subjects unable to lie down without moving for 10 minutes

– Women who are pregnant or cannot stop breast feeding for 24 hours

– Claustrophobic patients unable to tolerate the scans

– Standard safety exclusionary criteria for MRI such as metallic foreign bodies,
pacemaker, etc.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Safety and Efficacy Study Evaluating TRx0237 in Subjects With Mild to Moderate Alzheimer’s Disease

The purpose of this study is to determine the safety and efficacy of TRx0237 in the treatment
of subjects with mild to moderate Alzheimer’s Disease.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Diagnosis of all cause dementia and probable Alzheimer’s disease

– Clinical Dementia Rating (CDR) total score of 1 (mild) to 2 (moderate) and MMSE score
of 14-26 (inclusive)

– Age < 90 years - Modified Hachinski ischemic score of ≤ 4 - Females, if of child-bearing potential, must practice true abstinence or be competent to use adequate contraception and agree to maintain this throughout the study - Subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law is/are able to read, understand, and provide written informed consent - Has one (or more) identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥2 hours/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug - If currently taking an acetylcholinesterase inhibitor and/or memantine at the time of Screening, the subject must have been taking such medication(s) for ≥3 months. The dosage regimen must have remained stable for ≥6 weeks and it must be planned to remain stable throughout participation in the study. - Able to comply with the study procedures Exclusion Criteria: - Significant central nervous system (CNS) disorder other than Alzheimer's disease - Significant focal or vascular intracranial pathology seen on brain MRI scan - Clinical evidence or history of stroke, transient ischemic attack, significant head injury or other unexplained or recurrent loss of consciousness ≥15 minutes - Epilepsy - Major depressive disorder, schizophrenia, or other psychotic disorders, bipolar disorder, or substance (including alcohol) related disorders - Metal implants in the head (except dental), pacemaker, cochlear implants, or any other non-removable items that are contraindications to MRI - Resides in hospital or moderate to high dependency continuous care facility - History of swallowing difficulties - Pregnant or breastfeeding - Glucose-6-phosphate dehydrogenase deficiency - History of significant hematological abnormality or current acute or chronic clinically significant abnormality - Abnormal serum chemistry laboratory value at Screening deemed to be clinically relevant by the investigator - Clinically significant cardiovascular disease or abnormal assessments - Preexisting or current signs or symptoms of respiratory failure - Concurrent acute or chronic clinically significant immunologic, hepatic, or endocrine disease (not adequately treated) and/or other unstable or major disease other than Alzheimer's disease - Diagnosis of cancer within the past 2 years prior to Baseline (other than basal cell or squamous cell skin cancer or Stage 1 prostate cancer) unless treatment has resulted in complete freedom from disease for at least 2 years - Prior intolerance or hypersensitivity to methylthioninium-containing drug, similar organic dyes, or any of the excipients - Treatment currently or within 3 months before Baseline with any of the following medications: - Tacrine - Clozapine, olanzapine (and there is no intent to initiate therapy during the course of the study) - Carbamazepine, primidone - Drugs with a warning or precaution in the labeling about methemoglobinemia at approved doses - Current or prior participation in a clinical trial as follows: - Clinical trial of a product for cognition within 3 months of Screening (unless confirmed to have been randomized to placebo) - A clinical trial of a drug, biologic, therapeutic device, or medical food in which the last dose/administration was received within 28 days prior to Baseline [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Study of Idalopirdine in Patients With Mild – Moderate Alzheimer’s Disease Treated With Donepezil

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic
treatment of patients with mild-to-moderate Alzheimer’s disease (AD).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– The patient has a knowledgeable and reliable caregiver.

– The patient is an outpatient.

– The patient has probable AD.

– The patient has mild to moderate AD.

– Stable treatment with donepezil.

– The patient, if a woman, must have had her last natural menstruation ≥24 months prior
to baseline, OR be surgically sterile.

– The patient, if a man, agrees to protocol-defined use of effective contraception if
his female partner is of childbearing potential, OR must have been surgically
sterilised prior to the screening visit.

Exclusion Criteria:

– The patient has evidence of any clinically significant neurodegenerative disease, or
other serious neurological disorders other than AD.

– The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
Text Revision (DSM-IV-TR) Axis I disorder other than AD.

– The patient has evidence of clinically significant disease.

– The patient’s donepezil therapy is likely to be interrupted or discontinued during the
study.

– The patient is currently receiving memantine or has taken memantine within 2 months
prior to screening.

Other inclusion and exclusion criteria may apply.

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Allopregnanolone for Mild Cognitive Impairment Due to Alzheimer’s Disease or Mild AD

The purpose of this study is to evaluate the safety and tolerability of allopregnanolone, a
naturally occurring brain steroid, in mild cognitive impairment and early Alzheimer’s disease
participants. The primary goal is to determine the maximally tolerated dose.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Men or postmenopausal women

– 55 years of age or older

– Diagnosis of MCI due to AD or mild AD

– MMSE > 20 at screen

– Capacity to provide informed consent

– Residing in the community with a caregiver able to accompany the patient to clinic
visits

– No medical contraindications to participation

– Willingness to comply with study procedures

Exclusion Criteria:

– Use of benzodiazepines, sedative/hypnotics, anticonvulsants, antipsychotics, and other
drugs that might interact with the GABA-A receptor complex

– Seizure disorder, history of stroke, focal brain lesion, traumatic brain injury,
substance abuse, malignancy

– Clinically significant laboratory or ECG abnormality

– MRI indicative of any other significant abnormality, including but not limited to
evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations,
subdural hematoma, or space occupying lesions

– Any condition that would contraindicate an MRI such as the presence of metallic
objects in the eyes, skin, heart, or body

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

The purpose of this study is to test whether an investigational drug called solanezumab can
slow the progression of memory problems associated with brain amyloid (protein that forms
plaques in the brains of people with Alzheimer Disease [AD]).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30

– Has a global Clinical Dementia Rating (CDR) scale score at screening of 0

– Has a Logical Memory II score at screening of 6 to 18

– Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain
amyloid pathology at screening

– Has a study partner that is willing to participate as a source of information and has
at least weekly contact with the participant (contact can be in-person, via telephone
or electronic communication)

Exclusion Criteria:

– Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at
screening or baseline

– Lacks good venous access, such that intravenous drug delivery or multiple blood draws
would be precluded

– Has current serious or unstable illness including cardiovascular, hepatic, renal,
gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic,
or hematologic disease or other conditions that, in the investigator’s opinion, could
interfere with the analyses of safety and efficacy in this study

– Has had a history within the last 5 years of a serious infectious disease affecting
the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma
resulting in protracted loss of consciousness

– Has had a history within the last 5 years of a primary or recurrent malignant disease
with the exception of any in situ cancer that was appropriately treated and is being
appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or
in situ prostate cancer with normal prostate-specific antigen post-treatment

– Has a known history of human immunodeficiency virus (HIV), clinically significant
multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions
(including, but not limited to, erythema multiforme major, linear immunoglobulin A
dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

– Is clinically judged by the investigator to be at serious risk for suicide

– Has a history within the past 2 years of major depression or bipolar disorder as
defined by the most current version of the Diagnostic and Statistical Manual of Mental
Disorders (DSM)

– Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as
defined by the most current version of the DSM

Open-Label Inclusion Criteria:

– All participants who complete the placebo-controlled period will be allowed to
continue into the open-label period

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Active, not recruiting

Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage

To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic
intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We
hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid
Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage
(probably related to hypertension).

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Age : 40-90 years,

– Non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days
from hemorrhage onset) confirmed on brain imaging (CT and/or MRI).

– Correct visual, hearing and language functions to perform neuropsychological tests.

– Written consent of patient

Exclusion Criteria:

– Secondary causes of intracerebral hemorrhage : vascular malformations (Arteriovenous
malformation, intracranial aneurysm, Cavernous angioma, dural arteriovenous fistula),
cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, Cocaine
or alcohol use, Hemorrhagic ischemic stroke.

– Pregnancy

– Contraindication to MRI

– progressive neoplasm

– Cognitive impairment secondary to progressive neurological disease

– Depression,

– Drug addiction

Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Completed

A Phase 0, Open Label, Multi-Center, Exploratory and Safety Study of [F-18]T808

[F-18]T808 is being developed as a diagnostic radiopharmaceutical for PET imaging of the
human brain.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Low Probability for AD Participants (Group 1)

– Participant is of any race/gender/ethnicity who has reached his or her 55th birthday
at the time of informed consent.

– Participant provides written informed consent Participant is capable of complying with
study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education

– In the Investigator‟s opinion, participant has a low probability of being currently
positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined
in APPENDIX VI of XXX protocol

– Participant has no significant hepatic or renal disease as defined by previous medical
history and lab results are within the following ranges: Total bilirubin within 2x
institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of
normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x
institutional upper limits of normal BUN within 2x institutional upper limits of
normal

High Probability for AD Participants (Group 2)

– Participant is of any race/gender/ethnicity who has reached his or her 55th birthday
at the time of informed consent.

– Participant or participant‟s legally acceptable representative provides written
informed consent Participant is capable of complying with study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education In the Investigator‟s opinion,
*participant has a high probability of being currently positive for AD that is
determined by a Mini Mental State Examination (MMSE < 17) defined in APPENDIX VI of XXX protocol - Participant has no significant hepatic or renal disease as defined by previous medical history, and lab results are within the following ranges: Total bilirubin within 2x institutional upper limits of normal AST (SGOT) ≤ 2.5 x institutional upper limits of normal ALT (SGPT) ≤ 2.5 x institutional upper limits of normal Creatinine ≤ 2x institutional upper limits of normal BUN within 2x institutional upper limits of normal [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

A Phase 0, Open Label, Multi-center Exploratory and Safety Study of [F-18]T807

[F-18]T807 is being developed as a diagnostic radiopharmaceutical for PET imaging of the
human brain.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria; Low Probability for AD Participants (Group 1)

– Participant has reached his or her 55th birthday at the time of informed consent
(Participant is male or female of any race / ethnicity)

– Participant provides written informed consent

– Participant is capable of complying with study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education

– In the Investigator’s opinion, participant has a low probability of being currently
positive for AD as determined by a Mini Mental State Examination (MMSE ≥ 28) defined
in APPENDIX VI of protocol T807000, IND 114102

– Participant has no significant hepatic or renal disease as defined by previous medical
history and lab results are within the following ranges:

– Total bilirubin within 2x institutional upper limits of normal

– AST (SGOT) ≤ 2.5 x institutional upper limits of normal

– ALT (SGPT) ≤ 2.5 x institutional upper limits of normal

– Creatinine ≤ 2x institutional upper limits of normal

– BUN within 2x institutional upper limits of normal

High Probability for AD Participants (Group 2)

– Participant has reached his or her 55th birthday at the time of informed consent
(Participant is male or female of any race / ethnicity)

– Participant or participant’s legally acceptable representative provides written
informed consent

– Participant is capable of complying with study procedures

– Participant is capable of communicating with study personnel

– Participant understands and speaks English

– Participant has at least an 8th Grade education

– In the Investigator’s opinion, participant has a high probability of being currently
positive for AD that is determined by a Mini Mental State Examination (MMSE < 17) defined in APPENDIX VI of protocol T807000, IND 114102. - Participant has no significant hepatic or renal disease as defined by previous medical history, and lab results are within the following ranges: - Total bilirubin within 2x institutional upper limits of normal - AST (SGOT) ≤ 2.5 x institutional upper limits of normal - ALT (SGPT) ≤ 2.5 x institutional upper limits of normal - Creatinine ≤ 2x institutional upper limits of normal - BUN within 2x institutional upper limits of normal Exclusion Criteria; All Participants - Female participant is pregnant or nursing - Participant has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation - Participant has other neurodegenerative disease that is associated with cognitive impairment or dementia - Participant has a medical condition that might be associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome - Participant has a history of significant cerebrovascular disease - Participant has previously received [F-18]T807 at any time - Participant has been involved in an investigative, radioactive research procedure within the past 14 days - Participant has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality - Participant has a history in the last five years of significant prescription or non-prescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer’s Disease

The purpose of this study is to evaluate the safety and efficacy of 2 fixed doses of EVP-6124
compared to placebo for 26 weeks in subjects with mild to moderate Alzheimer’s disease
currently receiving stable treatment or previously treated with an acetylcholinesterase
inhibitor.

For information about this clinical trial here at USC or to see if you qualify, contact Ileana Aldana by email at ileana.aldana@med.usc.edu or by phone at (323) 865-0702 for more information.

Inclusion Criteria:

– Ages ≥55 and ≤85 years

– Informed consent form (ICF) signed by the subject or legally acceptable representative
before any study-specific procedures for the subject are performed and an ICF signed
by the support person/caregiver before any study-specific procedures for the support
person/caregiver are performed

– Clinical diagnosis of dementia due to probable AD consistent with criteria established
by a workgroup of the National Institute on Aging and the Alzheimer’s Disease
Association

– Clinical decline within 12 months before screening and onset of symptoms at least 12
months or longer before screening, which may include any documented cognition,
functional, or other objective assessment or the clinical judgment of the investigator
or the subject’s referring physician that the subject has experienced a clinical
decline within the last 12 months

– Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12
months before screening, with findings consistent with the diagnosis of dementia due
to AD without any other clinically significant comorbid pathologies. If an MRI or CT
scan is unavailable or occurred greater than 12 months before screening, this
assessment should be completed and the findings confirmed before the subject enters
the run-in period (Day -14) (copy of the report will be available at the study site)

– Mini-Mental State Examination (MMSE) score ≥14 and ≤24 at screening and confirmed on
Day 1 prior to randomization (fluctuations of ±2 points are acceptable on Day
1/baseline)

– Clinical Dementia Rating Global score (CDR-GS) ≥1 (at least mild dementia) at
screening and confirmed on Day 1 prior to randomization

– Modified Hachinski Ischemic Scale (mHIS) score ≤4 at screening

– Fertile, sexually active subjects (men and women) must use an effective method of
contraception during the study. Female subjects and the female partner of male
subjects must be surgically sterile (hysterectomy or bilateral tubal ligation),
postmenopausal for at least 1-year, or willing to practice adequate methods of
contraception if of childbearing potential (defined as consistent use of combined
effective methods of contraception [including at least 1 barrier method])

– Reliable and capable support person/caregiver, who if not living in the same
household, interacts with the subject approximately 4 times per week and will be
available to attend clinic visits in person when possible

– Subject living at home, senior residential setting, or an institutional setting
without the need for continuous (ie, 24-hour) nursing care

– General health status acceptable for participation in a 26-week study

– Fluency (oral and written) in the language in which the standardized tests will be
administered

– Receiving a stable dose of an acetylcholinesterase inhibitor (AChEI) (donepezil,
rivastigmine or galantamine) for at least 3 months (90 days) before screening and with
continuous dosing for at least 6 months OR not presently receiving an AChEI (at least
30 days before screening), but with a history of previous AChEI treatment (subjects
receiving donepezil 23 mg currently or within 3 months before screening are
ineligible)

Exclusion Criteria:

– Exposure to an experimental drug, experimental biologic or experimental medical device
within 2 months (60 days) before screening

– Prior participation in an amyloid vaccination clinical study at any time in the past
or completion of a passive amyloid vaccination study within 6 months before screening

– Inability to swallow a tablet

– In the judgment of the investigator, inability of the subject or the support
person/caregiver to complete a 26-week study

– Inability to be ≥75% compliant with single-blind study drug

– Inability to adequately cooperate or complete the cognitive testing procedures or any
study assessment

– Residence in a skilled nursing facility

– Untreated vitamin B12 or folate deficiency (if treated, must be stably treated for at
least 6 months before screening)

– Clinically significant (in the judgment of the investigator) abnormal serum
electrolytes (sodium, potassium, magnesium) after repeat testing

– Clinically significant untreated hypothyroidism (if treated, thyroid-stimulating
hormone level and thyroid supplementation dose must be stable for at least 6 months
before screening)

– Insufficiently controlled diabetes mellitus (in the judgment of the investigator) or
requiring insulin

– Renal insufficiency (serum creatinine >2.0 mg/dL)

– Malignant tumor within 3 years before screening (except squamous and basal cell
carcinoma or cervical carcinoma in situ or localized prostate cancer)

– Female subjects who are pregnant, nursing, or planning to become pregnant during the
study

– Unstable medical condition that is clinically significant in the judgment of the
investigator

– Alanine transaminase (ALT) or aspartate transaminase (AST) >2.5 times the upper limit
of normal

– History of myocardial infarction or unstable angina within 6 months before screening

– History of more than 1 myocardial infarction within 5 years before screening

– Clinically significant (in the judgment of the investigator) cardiac arrhythmia
(including atrial fibrillation), cardiomyopathy, or cardiac conduction defect
(subjects with a pacemaker are acceptable)

– Symptomatic hypotension or hypertension (supine diastolic blood pressure >95 mmHg) (in
the judgment of the investigator)

– Clinically significant abnormality on screening or baseline electrocardiogram (ECG),
including but not necessarily limited to a confirmed corrected QT interval (QTc) value
≥450 msec for males or ≥470 msec for females. In subjects with a QRS value >120msec,
those with a QTc value <500 msec may be eligible following discussion with the Medical Monitor. - Stroke within 18 months before screening, or history of a stroke concomitant with onset of dementia - History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI - Head trauma with clinically significant (in the judgment of the investigator) loss of consciousness within 12 months before screening or concurrent with the onset of dementia - Onset of dementia secondary (in the judgment of the investigator) to cardiac arrest, surgery with general anesthesia, or resuscitation - Specific degenerative central nervous system (CNS) disease diagnosis other than AD (eg, Huntington's disease, Creutzfeld-Jacob disease, Down's syndrome, Fronto-Temporal Dementia, Parkinson's disease) - Subjects with no history of prior treatment with an AChEI (donepezil, rivastigmine, or galantamine) - Memantine currently or within 30 days before screening - Antipsychotics; low doses (in the judgment of the investigator, except clozapine) are allowed only if given for sleep disturbances, agitation and/or aggression, and only if the subject has received a stable dose for at least 3 months before screening (but not within 8 hours before any cognitive test) - Tricyclic antidepressants and monoamine oxidase inhibitors; all other antidepressants are allowed only if the subject has received a stable dose for at least 3 months before screening - Antiepileptic medications if taken for control of seizures - Chronic intake of opioid-containing analgesics - Sedating H1 antihistamines - Nicotine therapy (including the patch), varenicline (Chantix), or similar therapeutic agent within 30 days before screening - Clinically significant urine drug screen or serum alcohol test result in the judgment of the investigator - History of ischemic colitis or ischemic enterocolitis [/fusion_toggle][/fusion_accordion] [/fusion_builder_column][fusion_builder_column row_column_index="2_3" type="1_1" background_position="left top" background_color="" border_size="" border_color="" border_style="solid" spacing="yes" background_image="" background_repeat="no-repeat" padding="" margin_top="0px" margin_bottom="0px" class="" id="" animation_type="" animation_speed="0.3" animation_direction="left" hide_on_mobile="no" center_content="no" min_height="none"]Click here to be directed to the clinicaltrials.gov website for complete and detailed information about this trial.

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