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.
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.
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.