Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
350 participants
INTERVENTIONAL
2018-07-31
2021-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BHV-4157
troriluzole, 280 mg (2 x 140 mg) capsules, QD
troriluzole
Oral BHV-4157 will be given daily for up to 48 weeks
Placebo
matching 280 mg (2 x 140 mg) placebo capsules, QD
Placebo oral capsule
Oral matching placebo will be given daily for up to 48 weeks
Interventions
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troriluzole
Oral BHV-4157 will be given daily for up to 48 weeks
Placebo oral capsule
Oral matching placebo will be given daily for up to 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* An Mini-Mental State Examination score of 14 to 24, inclusive, at screening.
* 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.
Exclusion Criteria
* 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.
50 Years
85 Years
ALL
No
Sponsors
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Alzheimer's Disease Cooperative Study (ADCS)
OTHER
Biohaven Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Xenoscience, Inc.
Phoenix, Arizona, United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
University of California, San Diego
La Jolla, California, United States
University of Southern California
Los Angeles, California, United States
SC3 Research Group - Pasadena
Pasadena, California, United States
Geriatric and Adult Psychiatry
Hamden, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH
Stamford, Connecticut, United States
Brain Matters Research
Delray Beach, Florida, United States
University of Miami
Miami, Florida, United States
USF Health Byrd Alzheimer's Institute
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Southern Illinois University
Springfield, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
University of Kentucky
Lexington, Kentucky, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Northern Light Acadia Hospital
Bangor, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Galen Research
Chesterfield, Missouri, United States
Cleveland Clinic Lou Ruvo Center
Las Vegas, Nevada, United States
Princeton Medical Institute
Princeton, New Jersey, United States
Columbia University
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY Upstate Medical University Department of Geriatrics
Syracuse, New York, United States
James J. Peters VAMC
The Bronx, New York, United States
Case Western Reserve University
Beachwood, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Tulsa Clinical Research
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Geisinger Medical Clinic
Wilkes-Barre, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
CBRI, Roper Hospital
Charleston, South Carolina, United States
Vanderbilt Memory & Alzheimer's Center
Nashville, Tennessee, United States
The Glenn Biggs Institute for Alzheimer's and Neurodegenerative Diseases,University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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References
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Qiu Y, Jacobs DM, Messer K, Salmon DP, Wellington CL, Stukas S, Revta C, Brewer JB, Leger GC, Askew B, Donahue L, Kaplita S, Coric V, Qureshi IA, Feldman HH; Alzheimer's Disease Cooperative Study T2 Protect AD Study Group. Prognostic value of plasma biomarkers for informing clinical trial design in mild-to-moderate Alzheimer's disease. Alzheimers Res Ther. 2025 May 2;17(1):97. doi: 10.1186/s13195-025-01745-3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BHV4157-203
Identifier Type: -
Identifier Source: org_study_id