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

NCT02792257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-05-09

Study results available
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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.

Conditions

Interventions

DRUG

Dronabinol (Marinol®)

5mg - 10mg daily dose

DRUG

Placebo

Daily dose

Sponsors & Collaborators

  • Mclean Hospital

    collaborator OTHER

  • Miami Jewish Health

    collaborator UNKNOWN

  • National Institute on Aging (NIA)

    collaborator NIH

  • Tufts Medical Center

    collaborator OTHER

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Paul Rosenberg · Johns Hopkins University

  • Brent Forester · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02792257 on ClinicalTrials.gov