Study of BHV-4157 in Alzheimer's Disease
Public ClinicalTrials.gov record NCT03605667. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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, were administered orally once daily. Duration of treatment is 48 weeks in double-blind phase. There is also a screening period of up to 42 days; and a 4-week post-treatment observation period. Eligible participants who completed the double-blind treatment phase had the opportunity to receive open-label troriluzole for up to 48 weeks in an open-label extension (OLE) phase.
Study identification
- NCT ID
- NCT03605667
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 350 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2018 (Actual)
- Primary completion
- Dec 15, 2020 (Actual)
- Completion
- Dec 23, 2021 (Actual)
- Last update posted
- Dec 6, 2023
2018 – 2021
United States locations
- U.S. sites
- 44
- U.S. states
- 25
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| 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 | — |
| James J. Peters VAMC | The Bronx | New York | 10468 | — |
| 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 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03605667, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 6, 2023 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03605667 live on ClinicalTrials.gov.