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

NCT06808984 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IM045-P06U1111-1313-8997
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 52

Brief 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.

Conditions

Agitation; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline

  The CMAI is a scale administered by qualified rater based on caregiver's input on 29 items that assess the frequency of manifestations of agitated behaviors in older adults. Each item is rated on a 7-point scale: 1 = "never", 2 = "less than once a week", 3 = "once or twice a week", 4 = "several times a week", 5 = "once or twice a day", 6 = "several times a day" and 7 = "several times per hour." Ratings pertain to the period of time over the previous 2 weeks preceding administration of the CMAI. CMAI total scores range from 29 to 203.

  Up to Week 8

Secondary Outcomes (17)

• Change in Clinical Global Impression-Severity (CGI-S)

  Up to Week 8

• Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score

  Up to Week 8

• CMAI sub-score change in Aggressive Behaviors

  Up to Week 8

• CMAI sub-score change in Physically Non-aggressive Behaviors

  Up to Week 8

• CMAI sub-score change in Verbally Agitated Behaviors

  Up to Week 8

Study Arms (3)

BMS-986368 Dose 1

EXPERIMENTAL

Drug: BMS-986368

BMS-986368 Dose 2

EXPERIMENTAL

Drug: BMS-986368

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BMS-986368 DRUG

Specified dose on specified days

Also known as: CC-97489

BMS-986368 Dose 1; BMS-986368 Dose 2

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (52)

Local Institution - 0046

Homewood, Alabama, 35209, United States

NOT YET RECRUITING

University of Alabama - Huntsville Regional Medical Campus

Huntsville, Alabama, 35801, United States

RECRUITING

NoesisPharma

Phoenix, Arizona, 85016, United States

RECRUITING

Local Institution - 0040

Scottsdale, Arizona, 85260, United States

NOT YET RECRUITING

Local Institution - 0017

Anaheim, California, 92805, United States

NOT YET RECRUITING

Inland Psychiatric Medical Group - Chino

Chino, California, 91710, United States

RECRUITING

Kaizen Brain Center

La Jolla, California, 92037, United States

RECRUITING

University of California San Diego - La Jolla

La Jolla, California, 92037, United States

RECRUITING

Shreenath Clinical Service - Lakewood

Lakewood, California, 90805, United States

RECRUITING

Accellacare - Sherman Oaks

Sherman Oaks, California, 91403, United States

RECRUITING

Next Level Clinical Trials

West Covina, California, 91790, United States

RECRUITING

Alliance Clinical -West Hills

West Hills, California, 91307, United States

RECRUITING

Local Institution - 0066

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Local Institution - 0053

Washington D.C., District of Columbia, 20060, United States

WITHDRAWN

Arrow Clinical Trials

Daytona Beach, Florida, 32117, United States

RECRUITING

ClinCloud

Maitland, Florida, 32751, United States

RECRUITING

Local Institution - 0007

Maitland, Florida, 32751, United States

NOT YET RECRUITING

Local Institution - 0022

Miami, Florida, 33125, United States

WITHDRAWN

Ocean Blue Medical Research Center

Miami, Florida, 33166, United States

RECRUITING

Local Institution - 0001

Tampa, Florida, 33607, United States

NOT YET RECRUITING

Charter Research - Lady Lake

The Villages, Florida, 32162, United States

RECRUITING

Advanced Discovery Research

Atlanta, Georgia, 30318, United States

RECRUITING

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

RECRUITING

CenExel iResearch, LLC

Savannah, Georgia, 31405, United States

RECRUITING

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96817, United States

RECRUITING

Local Institution - 0011

Marrero, Louisiana, 70072, United States

NOT YET RECRUITING

Local Institution - 0051

South Dartmouth, Massachusetts, 02747, United States

NOT YET RECRUITING

Local Institution - 0061

Missoula, Montana, 59804, United States

NOT YET RECRUITING

Be Well Clinical Studies - Omaha

Omaha, Nebraska, 68144, United States

RECRUITING

Oasis Clinical Trials

Las Vegas, Nevada, 89121, United States

RECRUITING

Local Institution - 0059

Livingston, New Jersey, 07039, United States

NOT YET 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

Hawthorne Health - Super Health Staten Island

Staten Island, New York, 10309, 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

K2 Medical Research - East Providence

East Providence, Rhode Island, 02914, United States

RECRUITING

Local Institution - 0031

Chattanooga, Tennessee, 37421, United States

NOT YET RECRUITING

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

RECRUITING

Vanderbilt University Medical Center- Village

Nashville, Tennessee, 37212, United States

RECRUITING

Pinnacle Clinical Research

Austin, Texas, 78626, United States

RECRUITING

Horizon Clinical Research Center - Houston

Cypress, Texas, 77065, United States

RECRUITING

ANESC Research

El Paso, Texas, 79912, United States

RECRUITING

North Pointe Psychiatry - Flower Mound

Flower Mound, Texas, 75028, United States

RECRUITING

Local Institution - 0020

Houston, Texas, 77030, United States

WITHDRAWN

Stryde Research - Plano

Plano, Texas, 75093, United States

RECRUITING

Be Well Clinical Studies

Round Rock, Texas, 78681, United States

RECRUITING

Boeson Research - Provo

Provo, Utah, 84604, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Psychomotor Agitation; Alzheimer Disease

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 5, 2025
• Study Start: June 9, 2025
• Primary Completion (Estimated): November 26, 2027
• Study Completion (Estimated): January 7, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (52)