IRB Study Number 25-770
Status Recruiting
Phase Phase 2
Location U Building - Mellen Center
Institutes Lerner Research Institute, Neurological Institute
Description
IRB Study 25-770, IM045-P06 (BALANCE-AAD-1): 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/MGLL Inhibitor, for the Treatment of Agitation in Participants with Alzheimer's Disease, is now open to accrual at Main Campus!
IM045-P06 is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, three-arm study of BMS-986368 in adults aged 55-90 with Alzheimer’s disease with agitation. The study will take place over 22 weeks, over 5 sequential periods: a 4-week screening period, a 2-week single-blinded, PRI period, a 6-week DBP, an optional 6-week double-blind ATE, and a 4-week SFU period. Participants will be randomized to receive either a placebo or a high or low-dose of BMS-986368.
Inclusion Criteria
- Ages 55-90
- 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 living facilities, or living at home and have an identified study partner (caregiver)
- Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable
Exclusion Criteria
- 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
- Other protocol-defined Inclusion/Exclusion criteria apply
