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NCT03605667 · ClinicalTrials.gov registry record · Phase 2
Study of BHV-4157 in Alzheimer's Disease
A Phase 2 study of Alzheimer Disease, sponsored by Biohaven Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 350
- Enrollment target
- 20
- Study locations
NCT03605667: Completed Phase 2 study of Alzheimer Disease, sponsored by Biohaven Pharmaceuticals.
NCT03605667 is a Phase 2 study of Alzheimer Disease that has completed, run by Biohaven Pharmaceuticals. The registered enrollment target is 350 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03605667, a Phase 2 study of Alzheimer Disease, has completed, sponsored by Biohaven Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 350 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The ADAS-Cog is a structured scale that evaluates memory (word recall, word recognition), reasoning (following commands), language (naming, comprehension), orientation, ideational praxis (placing a letter in an envelope) and constructional praxis (copying geometric designs). Ratings of spoken language, language comprehension, word finding difficulty, and ability to remember test instructions were also obtained. The test was scored in terms of errors on a scale ranging from 0 (best) to 70 (worse)
Conditions Studied
Interventions
- DRUG Placebo oral capsule
- DRUG troriluzole
Study Locations (20)
California
- Neurology Center of North Orange County - Fullerton
- University of California, San Diego - La Jolla
- University of Southern California - Los Angeles
- SC3 Research Group - Pasadena - Pasadena
Arizona
- Xenoscience, Inc. - Phoenix
- Barrow Neurological Institute - Phoenix
- Banner Sun Health Research Institute - Sun City
Connecticut
- Geriatric and Adult Psychiatry - Hamden
- Yale University School of Medicine - New Haven
- Ki Health PARTNERS LLC DBA NEW ENGLAND INSTITUTE FOR CLINICAL RESEARCH - Stamford
Florida
- Brain Matters Research - Delray Beach
- University of Miami - Miami
- USF Health Byrd Alzheimer's Institute - Tampa
Illinois
- Northwestern University - Chicago
- Great Lakes Clinical Trials - Chicago
- Southern Illinois University - Springfield
Indiana
- Indiana University - Indianapolis
Iowa
- University of Iowa - Iowa City
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2021-12-23 |
| Phase | Phase 2 |
What the finished NCT03605667 record still lists
NCT03605667 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03605667 names 20 study sites across 9 states, led by California, Arizona, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03605667 about?
NCT03605667 is a clinical study titled "Study of BHV-4157 in 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, were administered orally once daily. Duration of treatment is 48 weeks in double-blind phase. There is also a...
What is the current status of trial NCT03605667?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2018-07-31. Estimated completion is 2021-12-23.
What conditions does trial NCT03605667 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT03605667?
The interventions under investigation include: Placebo oral capsule (DRUG), troriluzole (DRUG).
Who is sponsoring clinical trial NCT03605667?
This trial is sponsored by Biohaven Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03605667 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03605667's enrollment target sits among peer trials
350 75th of 306 higher than 231 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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