RecruitingPhase 2

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

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)

Lead sponsor

Celgene

Asset

BMS-986368

Listed sites

Recruiting sites

Enrollment

120

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤24•Study partner/caregiver required

Primary endpoint

•Cohen-Mansfield Agitation Inventory (CMAI) total score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDIM045-P06

NCT IDNCT06808984

Secondary IDU1111-1313-8997WHO

Timeline

Milestones

Study first posted2025-02-05actual

Study start2025-06-09actual

Last update posted2026-06-02actual

Primary completion2027-11-26estimated

Study completion2028-01-07estimated

Assets

Drug assets

BMS-986368

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot 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.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Other clinical outcomes

Behavior / neuropsychiatric

9 endpoints

Primary/protocol endpoint

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

Time frame:Up to Week 8

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Up to Week 8

change from baseline, improvement

Secondary/protocol endpoint

CMAI sub-score change in Aggressive Behaviors

Time frame:Up to Week 8

change from baseline, improvement

Secondary/protocol endpoint

CMAI sub-score change in Physically Non-aggressive Behaviors

Time frame:Up to Week 8

change from baseline, improvement

Secondary/protocol endpoint

CMAI sub-score change in Verbally Agitated Behaviors

Time frame:Up to Week 8

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Up to Week 8

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in NPI-NH Agitation/Aggression Domain Score

Time frame:Up to Week 8

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Up to Week 8

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Up to Day 28 After Last Dose

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

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

Time frame:Up to Day 28 After Last Dose

event count, event

Secondary/protocol endpoint

Number of Participants with Serious Adverse Events (SAEs)

Time frame:Up to Day 28 After Last Dose

event count, event

Secondary/protocol endpoint

Number of Participants with Adverse Events (AEs)

Time frame:Up to Day 28 After Last Dose

event count, event

Secondary/protocol endpoint

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

Time frame:Up to Day 28 After Last Dose

change from baseline, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

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

Time frame:Up to Week 8

change from baseline, improvement

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

Number of Participants with Clinically Significant Laboratory Abnormalities

Time frame:Up to 28 Days After Last Dose

event count, event

Secondary/protocol endpoint/low confidence

Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)

Time frame:Up to Day 21 After Last Dose

descriptive

Secondary/protocol endpoint/low confidence

Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)

Time frame:Up to Day 21 After Last Dose

descriptive

Secondary/protocol endpoint/low confidence

Plasma Concentrations of BMS-986368

Time frame:Up to Week 14

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.