Study of BHV-4157 in Alzheimer's Disease



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - 85
Updated:4/6/2019
Start Date:July 31, 2018
End Date:February 2, 2020
Contact:Robert Berman, MD
Email:clinicaltrials@biohavenpharma.com
Phone:203-404-0410

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A Phase 2 Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Efficacy and Safety of BHV-4157 in Patients With Mild to Moderate Alzheimer's Disease

Preclinical models suggest that riluzole, the active metabolite of BHV-4157, may protect from
AD-related pathology and cognitive dysfunction. Titrated dose of BHV-4157 to 280 mg, or
placebo, taken orally once daily. Duration of treatment is 48 weeks. There is also a
screening period of up to 42 days; and a 4-week post-treatment observation period.


Key Inclusion Criteria:

- Age 50 to 85 (inclusive) at screening

- Diagnosed with probable Alzheimer's disease dementia: Core clinical criteria in
accordance with NIA/Alzheimer's Association Guidelines.

- Living in the community (includes assisted living facilities, but excludes long-term
care nursing facilities).

- Ambulatory, or able to walk with an assistive device, such as a cane or walker.

- Participants must have a study partner who has frequent interaction with them
(approximately >3-4 times per week), will be present for all clinic visits, and can
assist in compliance with study procedures.

- A brain MRI scan within 6 months of screening consistent with a diagnosis of
Alzheimer's disease.

- Participants should be treated with a stable dosage regimen of FDA-approved AD
medications (acetylcholinesterase inhibitors (AchEI) and/or memantine) for at least 3
months prior to screening. Participants should be expected to remain on a stable
dosage regimen of these medications for the duration of the trial.

- Participants who are not being treated with FDA-approved AD medications at the time of
screening, because they have contraindications to these medications, or because they
have previously failed treatment with these medications, are also eligible for
inclusion, if it is expected that they will not be treated with these medications for
the duration of the trial.

Key Exclusion Criteria:

- Hepatic impairment defined as Child-Pugh class of A or more severe liver impairment.

- Other neurodegenerative diseases and causes of dementias, including Parkinson's
disease and Huntington's disease, vascular dementia, CJD (Creutzfeldt-Jakob disease),
LBD (Lewy Body dementia), PSP (Progressive Supranuclear Palsy), AIDS (Acquired
Immunodeficiency Syndrome), or NPH (normal pressure hydrocephalus).

- History of a major depressive episode within the past 6 months of screening.

- Insulin-dependent diabetes or uncontrolled diabetes with HbA1c value >8.0 %.

- Cancer or a malignant tumor within the past 3 years, except patients who underwent
potentially curative therapy with no evidence of recurrence for >3 years. Patients
with stable prostate cancer or non-melanoma skin cancers are not excluded.

- Participation in another clinical trial for an investigational agent and having taken
at least one dose of study medication, unless confirmed as having been on placebo,
within 12 weeks prior to screening. The end of a previous investigational trial is
defined as the date of the last dose of an investigational agent.
We found this trial at
43
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Phone: 317-963-7418
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-550-4258
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Phone: 319-353-5158
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Los Angeles, California 90033
213) 740-2311
Phone: 323-442-7602
University of Southern California The University of Southern California is one of the world’s leading...
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Miami, Florida 33124
(305) 284-2211
Phone: 305-243-0184
University of Miami A private research university with more than 15,000 students from around the...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-305-7661
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-697-2716
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Phone: 503-494-6601
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Phone: 401-444-2421
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Phone: 585-760-6569
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Seattle, Washington 98104
(206) 543-2100
Phone: 206-764-2339
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Ann Arbor, Michigan 48105
Phone: 734-763-2211
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Bangor, Maine 04401
Phone: 207-973-7596
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6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Phone: 225-763-3190
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
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Beachwood, Ohio 44122
Phone: 216-464-6467
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Bronx, New York 10468
Phone: 212-659-8883
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Charleston, South Carolina 29401
Phone: 843-958-2618
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Chesterfield, Missouri 63005
Phone: 314-546-5888
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303 East Superior Street
Chicago, Illinois 60611
Phone: 312-503-2486
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Chicago, Illinois 60640
Phone: 773-275-3500
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Phone: 614-293-4969
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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East Lansing, Michigan 48824
Phone: 517-884-2286
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Fullerton, California 92835
Phone: 714-879-7200
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Hamden, Connecticut 06518
Phone: 203-288-0414
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
Phone: 858-246-3279
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Las Vegas, Nevada 89106
Phone: 702-483-6030
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Lexington, Kentucky
859) 257-9000
Phone: 859-323-3145
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Nashville, Tennessee 37212
Phone: 615-875-0590
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Phone: 203-764-8100
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Pasadena, California 91105
Phone: 626-250-2070
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Phoenix, Arizona 85004
Phone: 602-274-9500
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Phoenix, Arizona 85013
Phone: 602-406-7054
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Princeton, New Jersey 08540
Phone: 609-921-3555
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327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Phone: 217-545-9737
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Stamford, Connecticut 06905
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Sun City, Arizona 85351
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Syracuse, New York 13202
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Tampa, Florida 33613
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3201 Wedgewood Lane
The Villages, Florida 32162
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Tucson, Arizona 85724
Phone: 520-626-3576
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Tulsa, Oklahoma 74104
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Wilkes-Barre, Pennsylvania 18711
Phone: 570-214-2834
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Willow Grove, Pennsylvania 19090
Phone: 215-957-9250
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