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

Detailed criteria

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 ≤24. * 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 living…

Locations (78)

Local Institution - 0046
Homewood, Alabama
University of Alabama - Huntsville Regional Medical Campus
Huntsville, Alabama
256-551-4512
Local Institution - 0048
Phoenix, Arizona
Local Institution - 0040
Scottsdale, Arizona
Local Institution - 0017
Anaheim, California
Inland Psychiatric Medical Group.
Chino, California
909-488-9116

Summary

Eligibility

Interventions

Locations (78)