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NCT06808984 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
A Phase 2 study of Alzheimer Disease and Agitation, sponsored by Celgene.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT06808984: Recruiting Phase 2 study of Alzheimer Disease and Agitation, sponsored by Celgene.
NCT06808984 is a Phase 2 study of Alzheimer Disease and Agitation that is actively recruiting participants, run by Celgene. The registered enrollment target is 120 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06808984, a Phase 2 study of Alzheimer Disease and Agitation, is actively recruiting participants, sponsored by Celgene.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
Primary Outcome
The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BMS-986368
Study Locations (20)
California
- Local Institution - 0017 - Anaheim
- Inland Psychiatric Medical Group, Inc - Chino
- Kaizen Brain Center - La Jolla
- University of California San Diego - La Jolla - La Jolla
- Shreenath Clinical Service - Lakewood - Lakewood
- Accellacare - Sherman Oaks - Sherman Oaks
- Next Level Clinical Trials - West Covina
- Alliance Clinical -West Hills - West Hills
Florida
- Arrow Clinical Trials - Daytona Beach
- ClinCloud - Maitland
- Local Institution - 0007 - Maitland
- Local Institution - 0022 - Miami
- Ocean Blue Medical Research Center - Miami
- Local Institution - 0001 - Tampa
Alabama
- Local Institution - 0046 - Homewood
- University of Alabama - Huntsville Regional Medical Campus - Huntsville
Arizona
- NoesisPharma - Phoenix
- Local Institution - 0040 - Scottsdale
Colorado
- Local Institution - 0066 - Aurora
District of Columbia
- Local Institution - 0053 - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-06-09 |
| Est. Completion | 2028-01-07 |
| Phase | Phase 2 |
What NCT06808984 shows while recruiting
NCT06808984 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (96% lower).
The record links to 2 conditions, with Alzheimer Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06808984 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT06808984 about?
NCT06808984 is a clinical study titled "Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease". This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
What is the current status of trial NCT06808984?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2025-06-09. Estimated completion is 2028-01-07.
What conditions does trial NCT06808984 study?
This clinical trial studies the following conditions: Alzheimer Disease, Agitation.
What interventions are being tested in trial NCT06808984?
The interventions under investigation include: Placebo (DRUG), BMS-986368 (DRUG).
Who is sponsoring clinical trial NCT06808984?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06808984 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06808984's enrollment target sits among peer trials
120 139th of 306 higher than 162 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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