Recruiting
Phase 2

BMS-986368

Sponsor:

Celgene

Code:

NCT06808984

Conditions

Agitation

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

BMS-986368

Placebo

Study Details

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

Study ID

NCT06808984

Start date

Jun 9, 2025

Status verified date

Aug, 2026

Completion date

Jan 7, 2028

Anticipated

Primary completion date

Nov 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BMS-986368 Dose 1

experimental: BMS-986368 Dose 2

placebo comparator: Placebo

Interventions

BMS-986368

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

  • Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline [ Time Frame: Up to Week 8 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

University of Alabama - Huntsville Regional Medical Campus

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Tiffany Schwasinger-Schmidt, Site 0036

256-551-4512

Inland Psychiatric Medical Group.

Recruiting

Chino, California, United States, 91710

Contacts

Nandita Puchakayala, Site 0037

909-488-9116

Kaizen Brain Center

Recruiting

La Jolla, California, United States, 92037

Contacts

MOHAMMED AHMED, Site 0018

214-893-0542

University of California San Diego - La Jolla

Recruiting

La Jolla, California, United States, 92037

Contacts

Gabriel Leger, Site 0052

858-246-1303

Shreenath Clinical Service - Lakewood

Recruiting

Lakewood, California, United States, 90805

Contacts

ERIC TATE, Site 0050

714-717-6039

Next Level Clinical Trials

Recruiting

West Covina, California, United States, 91790

Contacts

Austina Cho, Site 0057

714-999-6688

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Samantha Holden, Site 0066

303-724-2046

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20057

Contacts

Brigid Reynolds, Site 0067

202-687-3350

Arrow Clinical Trials

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

David Billmeier, Site 0003

386-278-8000

ClinCloud

Recruiting

Maitland, Florida, United States, 32751

Contacts

Rosemary Laird, Site 0013

717-357-1569

Charter Research - Lady Lake

Recruiting

The Villages, Florida, United States, 32162

Contacts

Jeffrey Norton, Site 0039

352-775-1000

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Contacts

Kimball Johnson, Site 0035

404-537-1281

CenExel iResearch, LLC

Recruiting

Savannah, Georgia, United States, 31405

Contacts

Yael Elfassy, Site 0015

912-744-0800

K2 Medical Research

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

john stoukides, Site 0025

401-435-8950

Boeson Research

Recruiting

Missoula, Montana, United States, 59804

Contacts

Lisa Koehl, Site 0061

406-543-9700

Be Well Clinical Studies - Omaha

Recruiting

Omaha, Nebraska, United States, 68144

Contacts

John Puente, Site 0062

402-937-9293

University at Buffalo - UBMD Neurology

Recruiting

Buffalo, New York, United States, 14203

Contacts

Kinga Szigeti, Site 0034

281-630-2316

The Feinstein Institute for Medical Research

Recruiting

Manhasset, New York, United States, 11030

Contacts

Jeremy Koppel, Site 0049

516-562-3492

Mid Hudson Medical Research

Recruiting

New Windsor, New York, United States, 12553

Contacts

Sashi Makam, Site 0044

845-674-9398

Research Central LLC (DBA Ichor Research)

Recruiting

Syracuse, New York, United States, 13210

Contacts

Karl Hafner, Site 0021

315-529-0766

New Hope Clinical Research

Recruiting

Charlotte, North Carolina, United States, 28211

Contacts

Kurian Abraham, Site 0016

980-209-9784

UNC Health REX Hospital

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Sandeep Vaishnavi, Site 0063

919-784-1092

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Kasia Rothenberg, Site 0023

216-403-6847

Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

James Ellison, Site 0058

215-503-2823

Neurology Clinic, P.C.

Recruiting

Cordova, Tennessee, United States, 38018

Contacts

Thomas Arnold, Site 0019

901-866-9252

Vanderbilt University Medical Center- Village

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Joshua Smith, Site 0033

601-594-0792

Pinnacle Clinical Research

Recruiting

Austin, Texas, United States, 78626

Contacts

Rohit Puskoor, Site 0060

817-602-5188

Horizon Clinical Research Center - Houston

Recruiting

Cypress, Texas, United States, 77065

Contacts

Harpaul Gill, Site 0042

949-491-0710

ANESC Research

Recruiting

El Paso, Texas, United States, 79912

Contacts

Aamr Herekar, Site 0045

505-903-1715

Stryde Research - Plano

Recruiting

Plano, Texas, United States, 75093

Contacts

Peter Brokish, Site 0065

214-407-8640

Be Well Clinical Studies

Recruiting

Round Rock, Texas, United States, 78681

Contacts

Mark Carlson, Site 0038

000-000-0000

Boeson Research - Provo

Recruiting

Provo, Utah, United States, 84604

Contacts

Jason Andersen, Site 0027

385-392-2200

More Information

Sponsor

Celgene

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Celgene on 2026-09-01.