To Evaluate the Efficacy, Safety, and Tolerability of Dronabinol Oral Solution for Agitation in Patients With Alzheimer's Disease

This study tests a medication called dronabinol in people with Alzheimer's disease. First, participants go through up to 4 weeks of screening. Then, over 2 weeks, the dose of the study drug is slowly increased. For the next 10 weeks, participants stay on either dronabinol or a placebo. After finishing this part of the study, participants can join a 6-month extension where everyone receives dronabinol. Those already on the drug stay on their same dose, while those who were on placebo gradually increase their dose over 2 weeks. All participants take dronabinol for the rest of the extension, then complete a final safety check 4 weeks after stopping the medication. Usual medical treatments are continued throughout the study.

NCT Number	NCT07422311
Lead Sponsor	Benuvia Therapeutics Inc. Collaborators: Mandara
Conditions	Agitation in Dementia
Enrollment	140 participants
Start Date	2026-05-01
Primary Completion	2028-05-30 (estimated)
Study Completion	2028-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-02-25