RecruitingAgitationAlzheimer Disease

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

Eligible age

55–90 yrs

Accepts

All genders

Locations

22 states

Healthy volunteers

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About this study

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.

Sponsor: Celgene

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.