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BHV-4157 for Alzheimer's Disease (T2 Protect AD)

Active, not recruiting

BHV-4157, also known as troriluzole, is an investigational drug that researchers are testing to determine if it can protect against, slow down, and potentially improve memory and thinking problems in adults with mild to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years All No
July 31, 2018
December 20, 2020
292

  • Diagnoses of probable Alzheimer's disease
  • Living in the community or in an assisted living facility (long-term care nursing facilities excluded)
  • Able to walk with or without a device, such as a cane or walker
  • Study partner who has contact three to four times per week, can be present for all clinic visits, and can assist in following study procedures
  • A brain magnetic resonance imaging (MRI) scan in past 6 months that's consistent with a diagnosis of Alzheimer's disease
  • Participants should be treated with a stable dose of FDA-approved Alzheimer's medications (galantamine, rivastigmine, donepezil, and/or memantine) for at least 3 months and should be expected to remain on a stable dose for trial duration
  • Participants who are not being treated with FDA-approved Alzheimer's medications, because of contraindications or previously failed treatment, are also eligible for inclusion if not expected to be treated with these medications for trial duration

  • Other neurodegenerative diseases and causes of dementias, including Parkinson's disease, Huntington's disease, vascular dementia, Creutzfeldt-Jakob disease, Lewy body dementia, progressive supranuclear palsy, AIDS (acquired immunodeficiency syndrome), or normal pressure hydrocephalus
  • Major depressive episode in past 6 months
  • Hepatic impairment or more severe liver impairment
  • Insulin-dependent diabetes or uncontrolled diabetes with HbA1c value more than 8 percent
  • Cancer or a malignant tumor in past 3 years, except stable prostate cancer or non-melanoma skin cancers
  • Participation in another clinical trial for an investigational agent and having taken study medication within 12 weeks of screening (unless confirmed placebo)

Participants will take either a capsule of the study drug or placebo once a day for almost 2 years. Researchers will measure cognitive function, such as memory and reasoning, through assessments given to participants over nine study visits. At the beginning and end of the study, participants will have an MRI brain scan.

For more information about this study or study sites, call 203-404-0410, email clinicaltrials@biohavenpharma.com, or visit www.t2protect.org.

Name City State Zip Status Primary Contact
Xenoscience, Inc.
Phoenix Arizona 85004

Barrow Neurological Institute
Phoenix Arizona 85013

Banner Sun Health Research Institute
Sun City Arizona 85351

Neurology Center of North Orange County
Fullerton California 92835

University of California, San Diego
La Jolla California 92037

University of Southern California
Los Angeles California 90033

SC3 Research Group - Pasadena
Pasadena California 91105

Geriatric and Adult Psychiatry
Hamden Connecticut 06518

Yale University School of Medicine
New Haven Connecticut 06510

Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH
Stamford Connecticut 06905

Brain Matters Research
Delray Beach Florida 33445

University of Miami
Miami Florida 33136

USF Health Byrd Alzheimer's Institute
Tampa Florida 33613

Northwestern University
Chicago Illinois 60611

Great Lakes Clinical Trials
Chicago Illinois 60640

Southern Illinois University
Springfield Illinois 62702

Indiana University
Indianapolis Indiana 46202

University of Iowa
Iowa City Iowa 52242

University of Kentucky
Lexington Kentucky 40504

Pennington Biomedical Research Center
Baton Rouge Louisiana 70808

Northern Light Acadia Hospital
Bangor Maine 04401

Johns Hopkins University
Baltimore Maryland 21224

University of Michigan, Ann Arbor
Ann Arbor Michigan 48105

Michigan State University
East Lansing Michigan 48824

Galen Research
Chesterfield Missouri 63005

Cleveland Clinic Lou Ruvo Center
Las Vegas Nevada 89106

Princeton Medical Institute
Princeton New Jersey 08540

James J. Peters VAMC
Bronx New York 10468

Columbia University
New York New York 10032

University of Rochester Medical Center
Rochester New York 14620

SUNY Upstate Medical University Department of Geriatrics
Syracuse New York 13202

Case Western Reserve University
Beachwood Ohio 44122

Ohio State University
Columbus Ohio 43210

Tulsa Clinical Research
Tulsa Oklahoma 74104

Oregon Health and Science University
Portland Oregon 97239

Keystone Clinical Studies, LLC
Norristown Pennsylvania 19403

University of Pittsburgh
Pittsburgh Pennsylvania 15213

Geisinger Medical Clinic
Wilkes-Barre Pennsylvania 18711

Abington Neurological Associates
Willow Grove Pennsylvania 19090

Rhode Island Hospital
Providence Rhode Island 02903

CBRI, Roper Hospital
Charleston South Carolina 29401

Vanderbilt Memory & Alzheimer's Center
Nashville Tennessee 37212

The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases,University of Texas Health Science Center at San Antonio
San Antonio Texas 78229-3900

University of Washington
Seattle Washington 98108

Biohaven Pharmaceuticals, Inc.

  • Alzheimer's Disease Cooperative Study (ADCS)

Name Phone Email
Robert Berman, MD 203-404-0410 clinicaltrials@biohavenpharma.com

NCT03605667

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