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.
Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.
History of agitation with onset at least four weeks prior to Screening.
MMSE-1 score ≤24.
Clinically significant delusions/hallucinations requiring hospitalization.
History of bipolar disorder, schizophrenia, or schizoaffective disorder.
History of major depressive episode with psychotic features during the 12 months prior to Screening.
History of delirium within 30 days of Screening.
Parallel
BMS-986368
DrugSpecified dose on specified days
Placebo
DrugSpecified dose on specified days
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
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. CMAI total scores range from 29 to 203.
Change in Clinical Global Impression-Severity (CGI-S)
Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score
CMAI sub-score change in Aggressive Behaviors
CMAI sub-score change in Physically Non-aggressive Behaviors
