CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
Dronabinol (Marinol®) +1 moredrug
Likely dose
Dronabinol (Marinol®) 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02792257
NCT02792257Phase 2Completed

Pilot Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease

Johns Hopkins University·interventional·Posted Jun 7, 2016·Updated May 9, 2025

In Brief

A Phase 2 clinical trial evaluating Dronabinol (Marinol®) and Placebo for Alzheimer's Disease. Completed, enrolled 84 participants across 5 sites.

Detailed Summary

Alzheimer's disease (AD) is the most prevalent neurodegenerative disease of aging. Neuropsychiatric symptoms (NPS) in AD are a major cause of burden to patients, caregivers, and society and are near-universal at some point in the AD course. One of the most troubling of these symptoms is agitation (Agit-AD), typified by a variety of problem behaviors including combativeness, yelling, pacing, lack of cooperation with care, insomnia, and restlessness. There is a great need for better interventions that target Agit-AD, a major source of patient disability as well as caregiver burden and stress, particularly in the case of moderate to severe agitation. This pilot trial could open the door to "re-purposing" Dronabinol (Marinol®) as a novel and safe treatment for Agit-AD with significant public health impact.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 7, 2016
Enrollment StartMar 1, 2017
Primary CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 10.1 years ago

Interventions

Dronabinol (Marinol®)drug

5mg - 10mg daily dose

Placebodrug

Daily dose