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.

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 apply.

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

See Plan Description

See Plan Description