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NCT Number: NCT06808984

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

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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986368

Drug

Specified dose on specified days

Other names: CC-97489

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Clinical Global Impression-Severity (CGI-S)

    Time frame: Up to Week 8

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

    Time frame: Up to Week 8

  3. CMAI sub-score change in Aggressive Behaviors

    Time frame: Up to Week 8

  4. CMAI sub-score change in Physically Non-aggressive Behaviors

    Time frame: Up to Week 8

  5. CMAI sub-score change in Verbally Agitated Behaviors

    Time frame: Up to Week 8

  6. Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score

    Time frame: Up to Week 8

  7. Change in NPI-NH Agitation/Aggression Domain Score

    Time frame: Up to Week 8

  8. Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain

    Time frame: Up to Week 8

  9. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 28 After Last Dose

  10. Number of Participants with Serious Adverse Events (SAEs)

    Time frame: Up to Day 28 After Last Dose

  11. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 28 After Last Dose

  12. Number of Participants with Clinically Significant Laboratory Abnormalities

    Time frame: Up to 28 Days After Last Dose

  13. Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)

    Time frame: Up to Day 28 After Last Dose

  14. Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)

    Time frame: Up to Day 28 After Last Dose

  15. Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)

    Time frame: Up to Day 21 After Last Dose

  16. Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)

    Time frame: Up to Day 21 After Last Dose

  17. Plasma Concentrations of BMS-986368

    Time frame: Up to Week 14

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 5, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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