Phase 3 Trial of Nabilone for Treating Agitation in Alzheimers Disease Patients Including Effects on Behavior, Cognition, Nutrition, and Pain

What this Trial Is About

Researchers are evaluating whether nabilone, a synthetic cannabinoid approved for chemotherapy-related nausea, is an effective treatment for agitation in patients with Alzheimers disease AD. Agitation is common in AD and can worsen quality of life, increase caregiver burden, and speed institutionalization. Current treatments have limited effectiveness and notable risks, so this study aims to explore nabilones potential benefits for agitation and other symptoms in AD. Participants will be randomly assigned to receive either nabilone or placebo capsules for 8 weeks. Those in the nabilone group will have their dose gradually increased up to a maximum of 2 mg per day. After the treatment phase, all participants will be followed for an additional 8 weeks to monitor ongoing effects. The study uses a quadruple-blind design to compare outcomes between the two groups. During the study, participants will undergo assessments of agitation using the Cohen-Mansfield Agitation Inventory, as well as evaluations of behavior, cognition, weight, nutritional status, pain, and global clinical change. Caregivers will also participate in study visits and assessments. The research team will closely monitor these factors from the start through 8 weeks after treatment ends to understand the effects and safety of nabilone in this population.

Nabilone for Agitation Blinded Intervention Trial