Trial of Cannabidiol CBD Capsules for Treating Agitation in Alzheimers Disease Patients

What this Trial Is About

This trial studies whether cannabidiol CBD capsules can help manage agitation in patients with Alzheimers disease AD. It is a randomized, double-blind, placebo-controlled crossover study assessing the safety and effectiveness of CBD, while also exploring new biomarkers related to agitation severity and treatment response. Agitation is common in AD and linked to health problems and caregiver burden current treatments have limitations and safety concerns. Participants will receive either CBD or placebo capsules during two treatment phases, each lasting 8 weeks, separated by a 2-week placebo washout period. The CBD dose is gradually increased up to a maximum of 800 mg per day. The study involves 12 visits approximately every 2 weeks and 8 weekly telephone visits throughout the 19-week treatment period, followed by 4 weeks of observation after treatment ends. During the study, participants will undergo assessments of agitation using the Cohen-Mansfield Agitation Inventory and other evaluations including neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, weight, pain, and overall global change. Researchers will monitor these outcomes from baseline through 22 weeks to understand CBDs impact and safety in managing agitation in AD patients.

Cannabidiol Medication Intervention Trial