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

Phase 2

Not yet recruiting

• Conditions: Agitation; Alzheimer Disease
• Interventions: Drug: Placebo; Drug: BMS-986368

• Registration Number: NCT06808984
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-30
• Study First Posted: 2025-02-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Study Start: 2025-06-06
• Primary Completion: 2027-07-27
• Study Completion: 2027-09-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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 < 21
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
BMS-986368 Dose 1	BMS-986368	-
BMS-986368 Dose 2	BMS-986368	-

Primary Outcome Measures

Name	Time	Method
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline	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 Outcome Measures

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

Trial Locations

Locations (40)

Local Institution - 0052; 🇺🇸 La Jolla, California, United States

Local Institution - 0053; 🇺🇸 Washington, District of Columbia, United States

Local Institution - 0051; 🇺🇸 South Dartmouth, Massachusetts, United States

Local Institution - 0046; 🇺🇸 Homewood, Alabama, United States

Local Institution - 0036; 🇺🇸 Huntsville, Alabama, United States

Local Institution - 0048; 🇺🇸 Phoenix, Arizona, United States

Local Institution - 0040; 🇺🇸 Scottsdale, Arizona, United States

Local Institution - 0017; 🇺🇸 Anaheim, California, United States

Local Institution - 0028; 🇺🇸 Canoga Park, California, United States

Local Institution - 0037; 🇺🇸 Chino, California, United States

Local Institution - 0018; 🇺🇸 La Jolla, California, United States

Local Institution - 0043; 🇺🇸 Sherman Oaks, California, United States

Local Institution - 0003; 🇺🇸 Daytona Beach, Florida, United States

Local Institution - 0007; 🇺🇸 Maitland, Florida, United States

Local Institution - 0013; 🇺🇸 Maitland, Florida, United States

Local Institution - 0022; 🇺🇸 Miami, Florida, United States

Local Institution - 0010; 🇺🇸 Miami, Florida, United States

Local Institution - 0001; 🇺🇸 Tampa, Florida, United States

Local Institution - 0039; 🇺🇸 The Villages, Florida, United States

Local Institution - 0026; 🇺🇸 Atlanta, Georgia, United States

Local Institution - 0035; 🇺🇸 Decatur, Georgia, United States

Local Institution - 0015; 🇺🇸 Savannah, Georgia, United States

Local Institution - 0004; 🇺🇸 Honolulu, Hawaii, United States

Local Institution - 0011; 🇺🇸 Marrero, Louisiana, United States

Local Institution - 0041; 🇺🇸 North Las Vegas, Nevada, United States

Local Institution - 0034; 🇺🇸 Buffalo, New York, United States

Local Institution - 0049; 🇺🇸 Manhasset, New York, United States

Local Institution - 0021; 🇺🇸 Syracuse, New York, United States

Local Institution - 0016; 🇺🇸 Charlotte, North Carolina, United States

Local Institution - 0023; 🇺🇸 Cleveland, Ohio, United States

Local Institution - 0025; 🇺🇸 East Providence, Rhode Island, United States

Local Institution - 0031; 🇺🇸 Chattanooga, Tennessee, United States

Local Institution - 0019; 🇺🇸 Cordova, Tennessee, United States

Local Institution - 0033; 🇺🇸 Nashville, Tennessee, United States

Local Institution - 0042; 🇺🇸 Cypress, Texas, United States

Local Institution - 0045; 🇺🇸 El Paso, Texas, United States

Local Institution - 0024; 🇺🇸 Flower Mound, Texas, United States

Local Institution - 0020; 🇺🇸 Houston, Texas, United States

Local Institution - 0038; 🇺🇸 Round Rock, Texas, United States

Local Institution - 0027; 🇺🇸 Provo, Utah, United States