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

June 1, 2026 updated by: Celgene

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • University of Alabama - Huntsville Regional Medical Campus
        • Contact:
          • Tiffany Schwasinger-Schmidt, Site 0036
          • Phone Number: 256-551-4512
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Completed
        • Local Institution - 0048
      • Scottsdale, Arizona, United States, 85260
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
    • California
      • Anaheim, California, United States, 92805
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
      • Chino, California, United States, 91710
        • Recruiting
        • Inland Psychiatric Medical Group.
        • Contact:
          • Nandita Puchakayala, Site 0037
          • Phone Number: 909-488-9116
      • La Jolla, California, United States, 92037
        • Recruiting
        • Kaizen Brain Center
        • Contact:
          • MOHAMMED AHMED, Site 0018
          • Phone Number: 214-893-0542
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California San Diego - La Jolla
        • Contact:
          • Gabriel Leger, Site 0052
          • Phone Number: 858-246-1303
      • Lakewood, California, United States, 90805
        • Recruiting
        • Shreenath Clinical Service - Lakewood
        • Contact:
          • ERIC TATE, Site 0050
          • Phone Number: 714-717-6039
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Accellacare - Sherman Oaks
        • Contact:
          • Neeraj Gupta, Site 0043
          • Phone Number: 562-548-8500
      • West Covina, California, United States, 91790
        • Recruiting
        • Next Level Clinical Trials
        • Contact:
          • Austina Cho, Site 0057
          • Phone Number: 714-999-6688
      • West Hills, California, United States, 91307
        • Completed
        • Local Institution - 0028
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus
        • Contact:
          • Samantha Holden, Site 0066
          • Phone Number: 303-724-2046
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20060
        • Withdrawn
        • Local Institution - 0053
      • Washington D.C., District of Columbia, United States, 20007
        • Not yet recruiting
        • Local Institution - 0067
        • Contact:
          • Site 0067
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trials
        • Contact:
          • David Billmeier, Site 0003
          • Phone Number: 386-278-8000
      • Maitland, Florida, United States, 32751
        • Recruiting
        • ClinCloud
        • Contact:
          • Rosemary Laird, Site 0013
          • Phone Number: 717-357-1569
      • Maitland, Florida, United States, 32751
        • Not yet recruiting
        • Local Institution - 0007
        • Contact:
          • Site 0007
      • Miami, Florida, United States, 33125
        • Withdrawn
        • Local Institution - 0022
      • Miami, Florida, United States, 33166
        • Completed
        • Local Institution - 0010
      • Tampa, Florida, United States, 33607
        • Not yet recruiting
        • Local Institution - 0001
        • Contact:
          • Site 0001
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - Lady Lake
        • Contact:
          • Jeffrey Norton, Site 0039
          • Phone Number: 352-775-1000
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Completed
        • Local Institution - 0026
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Kimball Johnson, Site 0035
          • Phone Number: 404-537-1281
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Yael Elfassy, Site 0015
          • Phone Number: 912-744-0800
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Completed
        • Local Institution - 0004
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Not yet recruiting
        • Local Institution - 0011
        • Contact:
          • Site 0011
    • Massachusetts
      • South Dartmouth, Massachusetts, United States, 02747
        • Not yet recruiting
        • Local Institution - 0051
        • Contact:
          • Site 0051
    • Montana
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Boeson Research
        • Contact:
          • Lisa Koehl, Site 0061
          • Phone Number: 406-543-9700
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Recruiting
        • Be Well Clinical Studies - Omaha
        • Contact:
          • John Puente, Site 0062
          • Phone Number: 402-937-9293
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • Completed
        • Local Institution - 0041
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Not yet recruiting
        • Local Institution - 0059
        • Contact:
          • Site 0059
    • New York
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo - UBMD Neurology
        • Contact:
          • Kinga Szigeti, Site 0034
          • Phone Number: 281-630-2316
      • Manhasset, New York, United States, 11030
        • Recruiting
        • The Feinstein Institute for Medical Research
        • Contact:
          • Jeremy Koppel, Site 0049
          • Phone Number: 516-562-3492
      • New Windsor, New York, United States, 12553
        • Recruiting
        • Mid Hudson Medical Research
        • Contact:
          • Sashi Makam, Site 0044
          • Phone Number: 845-674-9398
      • Staten Island, New York, United States, 10309
        • Completed
        • Local Institution - 0064
      • Syracuse, New York, United States, 13210
        • Recruiting
        • Research Central LLC (DBA Ichor Research)
        • Contact:
          • Karl Hafner, Site 0021
          • Phone Number: 315-529-0766
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • New Hope Clinical Research
        • Contact:
          • Kurian Abraham, Site 0016
          • Phone Number: 980-209-9784
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • UNC Health REX Hospital
        • Contact:
          • Sandeep Vaishnavi, Site 0063
          • Phone Number: 919-784-1198
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Kasia Rothenberg, Site 0023
          • Phone Number: 216-403-6847
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience
        • Contact:
          • James Ellison, Site 0058
          • Phone Number: 215-503-2823
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Recruiting
        • K2 Medical Research - East Providence
        • Contact:
          • john stoukides, Site 0025
          • Phone Number: 401-435-8950
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
      • Cordova, Tennessee, United States, 38018
        • Recruiting
        • Neurology Clinic, P.C.
        • Contact:
          • Thomas Arnold, Site 0019
          • Phone Number: 901-866-9252
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Vanderbilt University Medical Center- Village
        • Contact:
          • Joshua Smith, Site 0033
          • Phone Number: 601-594-0792
    • Texas
      • Austin, Texas, United States, 78626
        • Recruiting
        • Pinnacle Clinical Research
        • Contact:
          • Rohit Puskoor, Site 0060
          • Phone Number: 817-602-5188
      • Cypress, Texas, United States, 77065
        • Recruiting
        • Horizon Clinical Research Center - Houston
        • Contact:
          • Harpaul Gill, Site 0042
          • Phone Number: 949-491-0710
      • El Paso, Texas, United States, 79912
        • Recruiting
        • ANESC Research
        • Contact:
          • Aamr Herekar, Site 0045
          • Phone Number: 505-903-1715
      • Flower Mound, Texas, United States, 75028
        • Recruiting
        • North Pointe Psychiatry - Flower Mound
        • Contact:
          • Asad Islam, Site 0024
          • Phone Number: 469-444-2244
      • Houston, Texas, United States, 77030
        • Withdrawn
        • Local Institution - 0020
      • Plano, Texas, United States, 75093
        • Recruiting
        • Stryde Research - Plano
        • Contact:
          • Peter Brokish, Site 0065
          • Phone Number: 214-407-8640
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Be Well Clinical Studies
        • Contact:
          • Mark Carlson, Site 0038
          • Phone Number: 000-000-0000
    • Utah
      • Provo, Utah, United States, 84604
        • Recruiting
        • Boeson Research - Provo
        • Contact:
          • Jason Andersen, Site 0027
          • Phone Number: 385-392-2200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: BMS-986368 Dose 1
Drug: BMS-986368
Specified dose on specified days
Other Names:
  • CC-97489
Experimental: BMS-986368 Dose 2
Drug: BMS-986368
Specified dose on specified days
Other Names:
  • CC-97489

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
Time Frame: Up to Week 8
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 Outcome Measures

Outcome Measure
Time Frame
Change in Clinical Global Impression-Severity (CGI-S)
Time Frame: Up to Week 8
Up to Week 8
CMAI sub-score change in Aggressive Behaviors
Time Frame: Up to Week 8
Up to Week 8
CMAI sub-score change in Physically Non-aggressive Behaviors
Time Frame: Up to Week 8
Up to Week 8
CMAI sub-score change in Verbally Agitated Behaviors
Time Frame: Up to Week 8
Up to Week 8
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score
Time Frame: Up to Week 8
Up to Week 8
Change in NPI-NH Agitation/Aggression Domain Score
Time Frame: Up to Week 8
Up to Week 8
Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain
Time Frame: Up to Week 8
Up to Week 8
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Number of Participants with Adverse Events (AEs)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Number of Participants with Clinically Significant Laboratory Abnormalities
Time Frame: Up to 28 Days After Last Dose
Up to 28 Days After Last Dose
Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time Frame: Up to Day 28 After Last Dose
Up to Day 28 After Last Dose
Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)
Time Frame: Up to Day 21 After Last Dose
Up to Day 21 After Last Dose
Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)
Time Frame: Up to Day 21 After Last Dose
Up to Day 21 After Last Dose
Plasma Concentrations of BMS-986368
Time Frame: Up to Week 14
Up to Week 14
Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score
Time Frame: Up to Week 8
Up to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2025

Primary Completion (Estimated)

November 26, 2027

Study Completion (Estimated)

January 7, 2028

Study Registration Dates

First Submitted

January 24, 2025

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM045-P06
  • U1111-1313-8997 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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