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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

RecruitingPhase 2

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)

Who can join

Ages 55 to 90 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Celgene · Participants: 120 · Started: Jun 9, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06808984

Locations in the U.S.

AlabamaLocal Institution - 0046, Homewood (Not yet recruiting)
University of Alabama - Huntsville Regional Medical Campus, Huntsville
ArizonaLocal Institution - 0040, Scottsdale (Not yet recruiting)
CaliforniaLocal Institution - 0017, Anaheim (Not yet recruiting)
Inland Psychiatric Medical Group., Chino
Kaizen Brain Center, La Jolla
University of California San Diego - La Jolla, La Jolla
Shreenath Clinical Service - Lakewood, Lakewood
Next Level Clinical Trials, West Covina
ColoradoUniversity of Colorado Anschutz Medical Campus, Aurora
District of ColumbiaGeorgetown University, Washington D.C.
FloridaArrow Clinical Trials, Daytona Beach
ClinCloud, Maitland
Local Institution - 0007, Maitland (Not yet recruiting)
Local Institution - 0001, Tampa (Not yet recruiting)
Local Institution - 0080, Tampa (Not yet recruiting)
Charter Research - Lady Lake, The Villages
GeorgiaCenExel iResearch, LLC, Decatur
CenExel iResearch, LLC, Savannah
LouisianaLocal Institution - 0011, Marrero (Not yet recruiting)
MassachusettsK2 Medical Research, Foxborough
Local Institution - 0051, South Dartmouth (Not yet recruiting)
MichiganLocal Institution - 0088, Sterling Heights (Not yet recruiting)
MontanaBoeson Research, Missoula
NebraskaBe Well Clinical Studies - Omaha, Omaha
New JerseyLocal Institution - 0059, Livingston (Not yet recruiting)
Local Institution - 0081, Toms River (Not yet recruiting)
New YorkUniversity at Buffalo - UBMD Neurology, Buffalo
The Feinstein Institute for Medical Research, Manhasset
Mid Hudson Medical Research, New Windsor
Research Central LLC (DBA Ichor Research), Syracuse
North CarolinaNew Hope Clinical Research, Charlotte
UNC Health REX Hospital, Raleigh
OhioCleveland Clinic, Cleveland
Local Institution - 0087, Columbus (Not yet recruiting)
OklahomaLocal Institution - 0089, Ardmore (Not yet recruiting)
PennsylvaniaThomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience, Philadelphia
TennesseeLocal Institution - 0031, Chattanooga (Not yet recruiting)
Neurology Clinic, P.C., Cordova
Vanderbilt University Medical Center- Village, Nashville
TexasPinnacle Clinical Research, Austin
Horizon Clinical Research Center - Houston, Cypress
ANESC Research, El Paso
Stryde Research - Plano, Plano
Local Institution - 0091, Richardson (Not yet recruiting)
Be Well Clinical Studies, Round Rock
UtahBoeson Research - Provo, Provo

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.