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Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

NCT ID: NCT06808984
Registry status: Recruiting
Study type: Interventional
Phase: Phase 2
Sponsor: Celgene
Conditions: Agitation, Alzheimer Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: 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)

Enrollment: 120 participants (Estimated).

What is being studied

Drug: BMS-986368
Drug: Placebo

Who may be eligible

Ages: 55 Years to 90 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility 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 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.

Study locations

77 study locations are listed.

Recruiting site status is explicitly provided for 77 locations; 32 are listed as Recruiting.

Countries: Argentina, Australia, China, United States

Buenos Aires, Argentina: 2
Córdoba Province, Argentina: 1
New South Wales, Australia: 1
South Australia, Australia: 1
Western Australia, Australia: 1
Anhui, China: 1
Beijing Municipality, China: 1
Hubei, China: 1
Jiangsu, China: 1
Shanghai Municipality, China: 1
Zhejiang, China: 1
Alabama, United States: 2
Arizona, United States: 2
California, United States: 8
Colorado, United States: 1
District of Columbia, United States: 2
Florida, United States: 8
Georgia, United States: 3
Hawaii, United States: 1
Illinois, United States: 1
Louisiana, United States: 1
Massachusetts, United States: 2
Michigan, United States: 1
Montana, United States: 1
Nebraska, United States: 1
Nevada, United States: 1
New Jersey, United States: 2
New York, United States: 5
North Carolina, United States: 2
Ohio, United States: 2

Sample of listed locations

University of Alabama - Huntsville Regional Medical Campus — Huntsville, Alabama, 35801, United States — Recruiting
Inland Psychiatric Medical Group. — Chino, California, 91710, United States — Recruiting
Kaizen Brain Center — La Jolla, California, 92037, United States — Recruiting
Shreenath Clinical Service - Lakewood — Lakewood, California, 90805, United States — Recruiting
Next Level Clinical Trials — West Covina, California, 91790, United States — Recruiting
University of Colorado Anschutz Medical Campus — Aurora, Colorado, 80045, United States — Recruiting
Georgetown University — Washington D.C., District of Columbia, 20057, United States — Recruiting
Arrow Clinical Trials — Daytona Beach, Florida, 32117, United States — Recruiting
ClinCloud — Maitland, Florida, 32751, United States — Recruiting
University of South Florida, Department of Psychiatry and Behavioral Neurosciences — Tampa, Florida, 33613, United States — Recruiting
Charter Research - Lady Lake — The Villages, Florida, 32162, United States — Recruiting
CenExel iResearch, LLC — Decatur, Georgia, 30030, United States — Recruiting
CenExel iResearch, LLC — Savannah, Georgia, 31405, United States — Recruiting
K2 Medical Research — Foxborough, Massachusetts, 02035, United States — Recruiting
Be Well Clinical Studies - Omaha — Omaha, Nebraska, 68144, United States — Recruiting
Ocean Medical Research — Toms River, New Jersey, 08755, United States — Recruiting
University at Buffalo - UBMD Neurology — Buffalo, New York, 14203, United States — Recruiting
The Feinstein Institute for Medical Research — Manhasset, New York, 11030, United States — Recruiting
Mid Hudson Medical Research — New Windsor, New York, 12553, United States — Recruiting
Research Central LLC (DBA Ichor Research) — Syracuse, New York, 13210, United States — Recruiting
New Hope Clinical Research — Charlotte, North Carolina, 28211, United States — Recruiting
UNC Health REX Hospital — Raleigh, North Carolina, 27607, United States — Recruiting
Cleveland Clinic — Cleveland, Ohio, 44195, United States — Recruiting
Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience — Philadelphia, Pennsylvania, 19107, United States — Recruiting
Neurology Clinic, P.C. — Cordova, Tennessee, 38018, United States — Recruiting

Study details

Start date: June 9, 2025
Primary completion date: November 26, 2027
Completion date: January 7, 2028
First posted: February 5, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06808984
Registry last updated: October 6, 2026
QualifiedStudies registry data refreshed: October 12, 2026
QualifiedStudies record fetched: October 12, 2026

View NCT06808984 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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