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NCT06808984PHASE2Recruiting

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

Celgene

Start Date

6/9/2025

Completion Date

1/7/2028

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 Criteria

Age Range: 55 years to 90 years

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.

Interventions

DRUG

BMS-986368

DRUG

Placebo

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Conditions

AgitationAlzheimer Disease

Locations

Local Institution - 0046

Homewood, Alabama 35209

United States

University of Alabama - Huntsville Regional Medical Campus

Huntsville, Alabama 35801

United States

Local Institution - 0048

Phoenix, Arizona 85028

United States

Local Institution - 0040

Scottsdale, Arizona 85260

United States

Local Institution - 0017

Anaheim, California 92805

United States

Inland Psychiatric Medical Group.

Chino, California 91710

United States

Kaizen Brain Center

La Jolla, California 92037

United States

University of California San Diego - La Jolla

La Jolla, California 92037

United States

Shreenath Clinical Service - Lakewood

Lakewood, California 90805

United States

Accellacare - Sherman Oaks

Sherman Oaks, California 91403

United States

Next Level Clinical Trials

West Covina, California 91790

United States

Local Institution - 0028

West Hills, California 91307

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045

United States

Local Institution - 0067

Washington D.C., District of Columbia 20007

United States

Local Institution - 0053

Washington D.C., District of Columbia 20060

United States

Arrow Clinical Trials

Daytona Beach, Florida 32117

United States

ClinCloud

Maitland, Florida 32751

United States

Local Institution - 0007

Maitland, Florida 32751

United States

Local Institution - 0022

Miami, Florida 33125

United States

Local Institution - 0010

Miami, Florida 33166

United States

Local Institution - 0001

Tampa, Florida 33607

United States

Charter Research - Lady Lake

The Villages, Florida 32162

United States

Local Institution - 0026

Atlanta, Georgia 30318

United States

CenExel iResearch, LLC

Decatur, Georgia 30030

United States

CenExel iResearch, LLC

Savannah, Georgia 31405

United States

Local Institution - 0004

Honolulu, Hawaii 96817

United States

Local Institution - 0011

Marrero, Louisiana 70072

United States

Local Institution - 0051

South Dartmouth, Massachusetts 02747

United States

Boeson Research

Missoula, Montana 59804

United States

Be Well Clinical Studies - Omaha

Omaha, Nebraska 68144

United States

Local Institution - 0041

Las Vegas, Nevada 89121

United States

Local Institution - 0059

Livingston, New Jersey 07039

United States

University at Buffalo - UBMD Neurology

Buffalo, New York 14203

United States

The Feinstein Institute for Medical Research

Manhasset, New York 11030

United States

Mid Hudson Medical Research

New Windsor, New York 12553

United States

Local Institution - 0064

Staten Island, New York 10309

United States

Research Central LLC (DBA Ichor Research)

Syracuse, New York 13210

United States

New Hope Clinical Research

Charlotte, North Carolina 28211

United States

UNC Health REX Hospital

Raleigh, North Carolina 27607

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience

Philadelphia, Pennsylvania 19107

United States

K2 Medical Research - East Providence

East Providence, Rhode Island 02914

United States

Local Institution - 0031

Chattanooga, Tennessee 37421

United States

Neurology Clinic, P.C.

Cordova, Tennessee 38018

United States

Vanderbilt University Medical Center- Village

Nashville, Tennessee 37212

United States

Pinnacle Clinical Research

Austin, Texas 78626

United States

Horizon Clinical Research Center - Houston

Cypress, Texas 77065

United States

ANESC Research

El Paso, Texas 79912

United States

North Pointe Psychiatry - Flower Mound

Flower Mound, Texas 75028

United States

Local Institution - 0020

Houston, Texas 77030

United States

Stryde Research - Plano

Plano, Texas 75093

United States

Be Well Clinical Studies

Round Rock, Texas 78681

United States

Boeson Research - Provo

Provo, Utah 84604

United States