Phase 2 Study of Oral BMS-986368 for Treating Agitation in Alzheimers Disease Patients Aged 55 to 90

What this Trial Is About

Researchers are evaluating BMS-986368, a FAAHMAGL inhibitor, for treating agitation in people with Alzheimers Disease. This Phase 2 study aims to assess the drugs effectiveness, safety, and tolerability in this population. Participants must have confirmed Alzheimers disease with biomarkers and meet specific agitation criteria based on established clinical definitions. Participants will be randomly assigned to receive one of two doses of BMS-986368 or a placebo. The study is double-blind and will take place across multiple centers. The treatment is given orally on specified days, and the study includes a placebo control for comparison. The trial is designed to last up to 8 weeks for primary assessments, with additional monitoring for safety and drug levels extending up to 14 weeks. Participants will undergo various assessments including the Cohen-Mansfield Agitation Inventory CMAI to measure agitation changes, Clinical Global Impression-Severity CGI-S, and Neuropsychiatric Inventory Nursing Home Version NPI-NH scores. Safety evaluations include monitoring adverse events and laboratory tests. The study also tracks potential withdrawal symptoms and drug plasma concentrations. Total participation may last up to 14 weeks, including follow-up after the last dose.

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