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

Alzheimer Disease Agitation

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new medication called BMS-986368 to treat agitation in people with Alzheimer's disease. Agitation — which can include restlessness, irritability, or aggressive behavior — is one of the most challenging symptoms of Alzheimer's for both patients and caregivers. **You may be eligible if...** - You have a confirmed diagnosis of Alzheimer's disease (with biomarker evidence) - You have been experiencing agitation for at least 4 weeks - Your cognitive score (MMSE) is below 21, indicating moderate-to-severe Alzheimer's - You live at home, in assisted living, or a nursing home and have a caregiver who can participate - You can move around on your own or with a mobility aid **You may NOT be eligible if...** - You have severe delusions or hallucinations requiring hospitalization - You have a history of bipolar disorder, schizophrenia, or schizoaffective disorder - You had a major depressive episode with psychotic features in the past year - You experienced delirium within the last 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBMS-986368

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days

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 - Chino

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

Next Level Clinical Trials

West Covina, California, United States

Alliance Clinical -West Hills

West Hills, California, United States

Local Institution - 0066

Aurora, Colorado, United States

Local Institution - 0053

Washington D.C., District of Columbia, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

ClinCloud

Maitland, Florida, United States

Local Institution - 0007

Maitland, Florida, United States

Local Institution - 0022

Miami, Florida, United States

Ocean Blue Medical Research Center

Miami, Florida, United States

Local Institution - 0001

Tampa, Florida, United States

Charter Research - Lady Lake

The Villages, Florida, United States

Advanced Discovery Research

Atlanta, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

CenExel iResearch, LLC

Savannah, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Local Institution - 0011

Marrero, Louisiana, United States

Local Institution - 0051

South Dartmouth, Massachusetts, United States

Local Institution - 0061

Missoula, Montana, United States

Be Well Clinical Studies - Omaha

Omaha, Nebraska, United States

Oasis Clinical Trials

Las Vegas, Nevada, United States

Local Institution - 0059

Livingston, New Jersey, United States

University at Buffalo - UBMD Neurology

Buffalo, New York, United States

The Feinstein Institute for Medical Research

Manhasset, New York, United States

Mid Hudson Medical Research

New Windsor, New York, United States

Hawthorne Health - Super Health Staten Island

Staten Island, New York, United States

Research Central LLC (DBA Ichor Research)

Syracuse, New York, United States

New Hope Clinical Research

Charlotte, North Carolina, United States

UNC Health REX Hospital

Raleigh, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience

Philadelphia, Pennsylvania, United States

K2 Medical Research - East Providence

East Providence, Rhode Island, United States

Local Institution - 0031

Chattanooga, Tennessee, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Vanderbilt University Medical Center- Village

Nashville, Tennessee, United States

Pinnacle Clinical Research

Austin, Texas, United States

Horizon Clinical Research Center - Houston

Cypress, Texas, United States

ANESC Research

El Paso, Texas, United States

North Pointe Psychiatry - Flower Mound

Flower Mound, Texas, United States

Local Institution - 0020

Houston, Texas, United States

Stryde Research - Plano

Plano, Texas, United States

Be Well Clinical Studies

Round Rock, Texas, United States

Boeson Research - Provo

Provo, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06808984

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