A Phase 2 interventional study of BMS-986368 and Placebo in Agitation and Alzheimer Disease, sponsored by Celgene. Recruiting at 77 sites in 4 countries. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Celgene (part of Bristol-Myers Squibb) · Phase 2, Interventional, and Treatment
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Celgene is the lead sponsor of 428 studies on the registry; 12 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 30 (29%) have results posted.
First submitted after Celgene became part of Bristol-Myers Squibb.
Compared within Alzheimer Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychomotor Agitation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: BMS-986368
Drug: BMS-986368
Drug: Placebo
Specified dose on specified days
Also known as: CC-97489
Specified dose on specified days
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
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.
Time frame: Up to Week 8
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
Change in Behaviour Assessed by Sheehan-Suicidality Tracking Scale (S-STS)
Time frame: Up to Day 28 After Last Dose
Abuse Potential Assessed by the Cannabis Withdrawal Scale (CWS)
Time frame: Up to Day 21 After Last Dose
Withdrawal Symptoms Assessed by the Cannabis Withdrawal Scale (CWS)
Time frame: Up to Day 21 After Last Dose
Plasma Concentrations of BMS-986368
Time frame: Up to Week 14
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Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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