Clinical trials

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Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 140
Trial details
Phase: Phase 2, Phase 3Age: 50-90Biological sex: AllType: InterventionalSponsor: Benuvia Therapeutics Inc.Updated: Feb 25, 2026Locations: 1
Eligibility criteria

1. Participant or legal representative is willing and capable of giving written... [+23]

1. Known hypersensitivity to the study drug or any of the study drug ingredients... [+26]