BMS-986368 for Alzheimer's Disease
Recruiting in Palo Alto (17 mi)
+34 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Celgene
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MGLL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
Research Team
BS
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Eligibility Criteria
This trial is for individuals with Alzheimer's Disease who experience agitation. Specific criteria for joining or being excluded from the study are not provided, but typically participants must meet certain health standards and may be excluded based on other medications they're taking or other health conditions.Inclusion Criteria
My agitation is diagnosed as per the IPA standards.
NPI-NH agitation/aggression sub-score ≥ 4
My memory and thinking skills test score is below 21.
See 4 more
Exclusion Criteria
History of bipolar disorder, schizophrenia, or schizoaffective disorder
Other protocol-defined Inclusion/Exclusion criteria apply
Clinically significant delusions/hallucinations requiring hospitalization
See 2 more
Treatment Details
Interventions
- BMS-986368 (FAAH/MGLL inhibitor)
Trial OverviewThe trial is testing BMS-986368, a drug intended to reduce agitation in people with Alzheimer's Disease. Participants will either receive this drug or a placebo (a substance with no active therapeutic effect) to compare outcomes.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BMS-986368 Dose 2Experimental Treatment1 Intervention
Group II: BMS-986368 Dose 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Trials
649
Recruited
130,000+
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Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania