A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)
Celgene
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.
Eligibility
- Age range
- 55–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 \< 21 * NPI-NH agitation/aggression sub-score ≥ 4. * Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted livin…
Interventions
- DrugBMS-986368
Specified dose on specified days
- DrugPlacebo
Specified dose on specified days
Locations (52)
- Local Institution - 0046Homewood, Alabama
- University of Alabama - Huntsville Regional Medical CampusHuntsville, Alabama
- NoesisPharmaPhoenix, Arizona
- Local Institution - 0040Scottsdale, Arizona
- Local Institution - 0017Anaheim, California
- Inland Psychiatric Medical Group - ChinoChino, California