INTERVENTIONALRECRUITINGNCT06808984
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)
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.gov↗last source update 2026-09-01
What this record can show
Protocol only - no registry results posted
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Study at a glance
- Phase
- PHASE2
- Enrollment
- 120 (ESTIMATED)
- Start date
- 2025-06-09
- Sponsor
- Celgene
- Design
- RANDOMIZED · PARALLEL · TREATMENT
- Locations
- 78
- Results record
- Not present in registry snapshot
AgitationAlzheimer Disease
Linked local records
Related local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Cannabinoids and active compounds
No governed compound link was found.
Medicines
No exact medicine-name link was found.
Interventions
What was registered
DRUGBMS-986368
Specified dose on specified days
CC-97489DRUGPlacebo
Specified dose on specified days
Eligibility
Population and criteria
- Sex
- ALL
- Minimum age
- 55 Years
- Maximum age
- 90 Years
- Healthy volunteers
- Not 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
primary outcomes
primary measures
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
secondary measures
Change in Clinical Global Impression-Severity (CGI-S)
Time frame: Up to Week 8
Change in CMAI-International Psychogeriatric Association (CMAI-IPA) Total Score
Time frame: Up to Week 8
CMAI sub-score change in Aggressive Behaviors
Time frame: Up to Week 8
CMAI sub-score change in Physically Non-aggressive Behaviors
Time frame: Up to Week 8
CMAI sub-score change in Verbally Agitated Behaviors
Time frame: Up to Week 8
Change in Neuropsychiatric Inventory Nursing Home Version (NPI-NH) Total Score
Time frame: Up to Week 8
Change in NPI-NH Agitation/Aggression Domain Score
Time frame: Up to Week 8
Change in NPI-NH Occupational Disruptiveness for Agitation/aggression Domain
Time frame: Up to Week 8
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 28 After Last Dose
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 28 After Last Dose
Number of Participants with Adverse Events (AEs)
Time frame: Up to Day 28 After Last Dose
Number of Participants with Clinically Significant Laboratory Abnormalities
Time frame: Up to 28 Days After Last Dose
Change in Suicidal Ideation Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time frame: Up to Day 28 After Last Dose
Publications
Locally readable linked articles
No exact PMID-linked public article is currently readable locally.
Snapshot provenance
- Snapshot
- f0491afd-5f79-4b3b-842b-22ca35a0ffb5
- Retrieved
- 11/09/2026, 14:17:20
- SHA-256
- 8b26fea65376ca52cc65f737edbb025c9973f9fbac22a21b1349fa38081e1761