Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agit… (NCT06808984) | Clinical Trial Compass
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
United States120 participantsStarted 2025-06-09
Plain-language 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.
Who can participate
Age range55 Years – 90 Years
SexALL
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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.
What they're measuring
1
Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline
Timeframe: Up to Week 8
Trial details
NCT IDNCT06808984
SponsorCelgene
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-11-26
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com