Clinical trial NCT06808984: Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
Official 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Agitation
Alzheimer Disease
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2025-02-05
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
timeFrame: Up to Week 8
Secondary outcomes:
measure: Change in Clinical Global Impression-Severity (CGI-S)
timeFrame: Up to Week 8
measure: Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score
timeFrame: Up to Week 8
measure: CMAI sub-score change in Aggressive Behaviors
timeFrame: Up to Week 8
measure: CMAI sub-score change in Physically Non-aggressive Behaviors
timeFrame: Up to Week 8
measure: CMAI sub-score change in Verbally Agitated Behaviors
timeFrame: Up to Week 8
measure: Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score
timeFrame: Up to Week 8
measure: Change in NPI-NH Agitation/Aggression Domain Score
timeFrame: Up to Week 8
measure: Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain
timeFrame: Up to Week 8
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 28 After Last Dose
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 28 After Last Dose
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to Day 28 After Last Dose
measure: Number of Participants with Clinically Significant Laboratory Abnormalities
timeFrame: Up to 28 Days After Last Dose
measure: Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
timeFrame: Up to Day 28 After Last Dose
measure: Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
timeFrame: Up to Day 28 After Last Dose
measure: Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)
timeFrame: Up to Day 21 After Last Dose
measure: Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)
timeFrame: Up to Day 21 After Last Dose
measure: Plasma Concentrations of BMS-986368
timeFrame: Up to Week 14
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Local Institution - 0046
state: Alabama
city: Huntsville
country: United States
facility: Local Institution - 0036
state: Alabama
city: Phoenix
country: United States
facility: Local Institution - 0048
state: Arizona
city: Scottsdale
country: United States
facility: Local Institution - 0040
state: Arizona
city: Anaheim
country: United States
facility: Local Institution - 0017
state: California
city: Canoga Park
country: United States
facility: Local Institution - 0028
state: California
city: Chino
country: United States
facility: Local Institution - 0037
state: California
city: La Jolla
country: United States
facility: Local Institution - 0018
state: California
city: La Jolla
country: United States
facility: Local Institution - 0052
state: California
city: Sherman Oaks
country: United States
facility: Local Institution - 0043
state: California
city: West Covina
country: United States
facility: Local Institution - 0057
state: California
city: Washington
country: United States
facility: Local Institution - 0053
state: District of Columbia
city: Daytona Beach
country: United States
facility: Local Institution - 0003
state: Florida
city: Maitland
country: United States
facility: Local Institution - 0007
state: Florida
city: Maitland
country: United States
facility: Local Institution - 0013
state: Florida
city: Miami
country: United States
facility: Local Institution - 0022
state: Florida
city: Miami
country: United States
facility: Local Institution - 0010
state: Florida
city: Tampa
country: United States
facility: Local Institution - 0001
state: Florida
city: The Villages
country: United States
facility: Local Institution - 0039
state: Florida
city: Atlanta
country: United States
facility: Local Institution - 0026
state: Georgia
city: Decatur
country: United States
facility: Local Institution - 0035
state: Georgia
city: Savannah
country: United States
facility: Local Institution - 0015
state: Georgia
city: Honolulu
country: United States
facility: Local Institution - 0004
state: Hawaii
city: Marrero
country: United States
facility: Local Institution - 0011
state: Louisiana
city: South Dartmouth
country: United States
facility: Local Institution - 0051
state: Massachusetts
city: North Las Vegas
country: United States
facility: Local Institution - 0041
state: Nevada
city: Buffalo
country: United States
facility: Local Institution - 0034
state: New York
city: Manhasset
country: United States
facility: Local Institution - 0049
state: New York
city: Syracuse
country: United States
facility: Local Institution - 0021
state: New York
city: Charlotte
country: United States
facility: Local Institution - 0016
state: North Carolina
city: Cleveland
country: United States
facility: Local Institution - 0023
state: Ohio
city: East Providence
country: United States
facility: Local Institution - 0025
state: Rhode Island
city: Chattanooga
country: United States
facility: Local Institution - 0031
state: Tennessee
city: Cordova
country: United States
facility: Local Institution - 0019
state: Tennessee
city: Nashville
country: United States
facility: Local Institution - 0033
state: Tennessee
city: Cypress
country: United States
facility: Local Institution - 0042
state: Texas
city: El Paso
country: United States
facility: Local Institution - 0045
state: Texas
city: Flower Mound
country: United States
facility: Local Institution - 0024
state: Texas
city: Houston
country: United States
facility: Local Institution - 0020
state: Texas
city: Round Rock
country: United States
facility: Local Institution - 0038
state: Texas
city: Provo
country: United States
facility: Local Institution - 0027
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: