Dronabinol to Treat Agitation in Alzheimer's Disease

What Is This Study About?

This trial will test the safety and effectiveness of dronabinol (Marinol) to reduce agitation in older adults with Alzheimer's. Dronabinol is a synthetic form of an active ingredient in cannabis and is an approved medication to treat chemotherapy-related nausea and AIDS-related lack of appetite. In this Phase 2 trial, participants will take either a 5-mg dronabinol capsule or placebo twice daily the first week, and a 10-mg capsule or placebo twice daily for weeks two and three. Researchers will assess the safety and effectiveness of the medication on reducing symptoms of agitation and aggression.

Do I Qualify To Participate in This Study?

Must have:

• Diagnosis of Alzheimer's disease
• Severe agitation (excessive movement, verbal aggression, or physical aggression) and emotional distress
• Must be admitted to clinical sites associated with McLean Hospital, Johns Hopkins University, and Miami Jewish Health Services as an inpatient/long term care resident during the study duration (3 weeks) OR be able to travel to these locations to enroll as an outpatient
• Able to begin study within one week of approved eligibility
• Fluent in verbal and written English or Spanish

Must NOT have:

• Serious or unstable medical illness, including heart, liver, kidney, respiratory, endocrine, neurologic, or blood disease
• Seizure disorder
• Delirium
• Use of lithium
• Inability to swallow a pill

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Where Is This Study Located?

Florida
Miami Jewish Health Miami, FL 33137 Recruiting Victoria Petrulla 305-751-8626 vpetrulla@miamijewishhealth.org
Maryland
Johns Hopkins University Baltimore, MD 21224 Recruiting Mersania Jn Pierre, B.A. 410-550-4969 mjnpier1@jhmi.edu
Massachusetts
McLean Hospital Belmont, MA 02478 Recruiting Rosain Ozonsi, B.S. 617-866-2511 rozonsi@mclean.harvard.edu
Tufts Medical Center Boston, MA 02111 Recruiting Todd Laffaye, B.A. 860-385-3866 todd.laffaye@tuftsmedicine.org
North Shore Medical Center Salem, MA 01970 Recruiting Rosain Ozonsi, B.A. 617-866-2511 rozonsi@mclean.harvard.edu

Who Sponsors This Study?

Lead: Johns Hopkins University

Collaborator Sponsor

• McLean Hospital

Source: ClinicalTrials.gov ID: NCT02792257