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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT06808984•Celgene

View on ClinicalTrials.gov

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

55 - 90 years

Sex

ALL

Healthy Volunteers

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.
•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.

Locations (52)

Local Institution - 0046

Homewood, Alabama, United States

University of Alabama - Huntsville Regional Medical Campus

Huntsville, Alabama, United States

NoesisPharma

Phoenix, Arizona, United States

Local Institution - 0040

Scottsdale, Arizona, United States

Local Institution - 0017

Anaheim, California, United States

Inland Psychiatric Medical Group, Inc

Chino, California, United States

Kaizen Brain Center

La Jolla, California, United States

University of California San Diego - La Jolla

La Jolla, California, United States

Shreenath Clinical Service - Lakewood

Lakewood, California, United States

Accellacare - Sherman Oaks

Sherman Oaks, California, United States

Key Dates

Start Date

June 9, 2025

Primary Completion Date

November 26, 2027

Completion Date

January 7, 2028

Last Updated

January 26, 2026

Enrollment

120

ESTIMATED participants

Conditions

AgitationAlzheimer Disease

Interventions

BMS-986368

DRUG

Placebo

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

8559073286 Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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