RecruitingPhase 2NCT06808984
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
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)
Sponsor
Celgene
Enrollment
120 participants
Start Date
Jun 9, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 55 YearsMax Age: 90 Years
Inclusion Criteria7
- 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 Criteria4
- 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.
Interventions
DRUGBMS-986368
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Locations(52)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06808984
Related Trials
Novel Augmentation of DAOIB and Antioxidant for Early Dementia
NCT064675391 location
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
NCT06937229241 locations
Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease
NCT071782101 location
Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease
NCT041233141 location
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
NCT06585787278 locations