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

Prior treatment

• History of major depressive episode with psychotic features during the 12 months prior to Screening.

Other illness

• History of bipolar disorder, schizophrenia, or schizoaffective disorder.
• History of delirium within 30 days of Screening.

Other

• Clinically significant delusions/hallucinations requiring hospitalization.
• Other protocol-defined Inclusion/Exclusion criteria apply.

• 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.