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Study of BMS-986368 for Agitation in Alzheimer's Disease

This study is testing a drug called BMS-986368 to see if it can help reduce agitation in people with Alzheimer's disease. Researchers want to understand how well it works, if it's safe, and if people can tolerate it. You might be able to join if you are between 55 and 90 years old, have a confirmed diagnosis of Alzheimer's disease, and have experienced agitation for at least four weeks. Success in this study will be measured by changes in agitation levels, as assessed by a specific rating scale, over a period of up to 8 weeks. The current recruitment status for this study is unclear, and it aims to enroll about 120 participants.

Study design
This study is designed to compare BMS-986368 with a placebo (an inactive substance) in about 120 participants. It is an interventional study, but the phase is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measure of success is taken up to Week 8, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06808984

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

Recruiting
PHASE2Ages 55–90InterventionalTreatment
Celgene
~120 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:BMS-986368Placebo

At a glance

Recruiting sites
33 of 75 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
Measured over Up to Week 8

Conditions

Agitation
Alzheimer Disease

Explore related trials

AgitationAlzheimer's Disease

Where it's being run

75 sites across 36 states
California8
Florida8
Texas8
New York5
Argentina4
Georgia3
Tennessee3
Alabama2

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

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