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

Use our guide to learn which trials are right for you!

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
Sun City, Arizona 85351
Phone: 623-832-6527
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
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...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
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...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
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...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
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...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
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...
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
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...
?
mi
from
Portland, OR
Click here to add this to my saved trials
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,...
?
mi
from
Providence, RI
Click here to add this to my saved trials
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...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Phone: 206-764-2339
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Ann Arbor, Michigan 48105
Phone: 734-763-2211
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Bangor, Maine 04401
Phone: 207-973-7596
?
mi
from
Bangor, ME
Click here to add this to my saved trials
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...
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beachwood, Ohio 44122
Phone: 216-464-6467
?
mi
from
Beachwood, OH
Click here to add this to my saved trials
Bronx, New York 10468
Phone: 212-659-8883
?
mi
from
Bronx, NY
Click here to add this to my saved trials
Charleston, South Carolina 29401
Phone: 843-958-2618
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chesterfield, Missouri 63005
Phone: 314-546-5888
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
Phone: 312-503-2486
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chicago, Illinois 60640
Phone: 773-275-3500
?
mi
from
Chicago, IL
Click here to add this to my saved trials
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...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
East Lansing, Michigan 48824
Phone: 517-884-2286
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
Fullerton, California 92835
Phone: 714-879-7200
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Hamden, Connecticut 06518
Phone: 203-288-0414
?
mi
from
Hamden, CT
Click here to add this to my saved trials
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...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Las Vegas, Nevada 89106
Phone: 702-483-6030
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
Phone: 859-323-3145
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Nashville, Tennessee 37212
Phone: 615-875-0590
?
mi
from
Nashville, TN
Click here to add this to my saved trials
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...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Pasadena, California 91105
Phone: 626-250-2070
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Phoenix, Arizona 85004
Phone: 602-274-9500
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85013
Phone: 602-406-7054
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Princeton, New Jersey 08540
Phone: 609-921-3555
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
327 W Calhoun Ave
Springfield, Illinois 62702
(217) 545-0223
Phone: 217-545-9737
Southern Illinois University From its humble beginnings as the state's second teachers college - founded...
?
mi
from
Springfield, IL
Click here to add this to my saved trials
Stamford, Connecticut 06905
Phone: 203-914-1903
?
mi
from
Stamford, CT
Click here to add this to my saved trials
Syracuse, New York 13202
Phone: 315-464-9017
?
mi
from
Syracuse, NY
Click here to add this to my saved trials
Tampa, Florida 33613
Phone: 813-974-4904
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3201 Wedgewood Lane
The Villages, Florida 32162
Phone: 352-261-0901
?
mi
from
The Villages, FL
Click here to add this to my saved trials
Tucson, Arizona 85724
Phone: 520-626-3576
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tulsa, Oklahoma 74104
Phone: 918-743-2349
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Wilkes-Barre, Pennsylvania 18711
Phone: 570-214-2834
?
mi
from
Wilkes-Barre, PA
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
Phone: 215-957-9250
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials