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NCT02792257 · ClinicalTrials.gov registry record · Phase 2
Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT02792257: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT02792257 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 84 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02792257, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study 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.
Primary Outcome
The Pittsburgh Agitation Scale (PAS) is a tool used to assess the severity of agitation in patients, particularly with dementia. The minimum score is 0 and the maximum score is 16. A higher number means a worse outcome, meaning more agitation.
Interventions
- DRUG Placebo
- DRUG Dronabinol (Marinol®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2024-05-31 |
| Phase | Phase 2 |
What the finished NCT02792257 record still lists
NCT02792257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02792257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02792257 about?
NCT02792257 is a clinical study titled "Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease". 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 (A...
What is the current status of trial NCT02792257?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2017-03-01. Estimated completion is 2024-05-31.
What interventions are being tested in trial NCT02792257?
The interventions under investigation include: Placebo (DRUG), Dronabinol (Marinol®) (DRUG).
Who is sponsoring clinical trial NCT02792257?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02792257's enrollment target sits among peer trials
84 822nd of 2000 higher than 1,173 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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