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Dronabinol to Treat Agitation in Alzheimer's Disease

Recruiting

This trial will test the safety and efficacy of dronabinol (Marinol), a medication approved to treat chemotherapy-related nausea and vomiting and AIDS-related lack of appetite, in treating agitation in older adults with Alzheimer's.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years 90 Years All No
March 1, 2017
December 2020
160

  • Diagnosis of Alzheimer's disease
  • Severe agitation (excessive movement, verbal aggression, or physical aggression) and emotional distress
  • Able to stay at McLean Hospital in Belmont, MA, Miami Jewish Hospital in Miami, FL, or Johns Hopkins Hospital in Baltimore, MD, for the 3-week study
  • Able to begin study within 1 week of approved eligibility
  • Fluent in verbal and written English or Spanish

  • 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

Dronabinol is a synthetic form of delta-9-tetrahydrocannabinol, a psychoactive chemical and active ingredient in cannabis. In this phase II 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 2 and 3. Researchers will assess the safety and effectiveness of the medication on reducing symptoms of agitation and aggression.

Name City State Zip Status Primary Contact
Johns Hopkins University
Baltimore Maryland 21224 Recruiting John Outen, M.S.
410-550-7385
jouten3@jhmi.edu
McLean Hospital
Belmont Massachusetts 02478 Recruiting Patrick Monette
617-855-2591
PMONETTE@MCLEAN.HARVARD.EDU

Johns Hopkins University

  • McLean Hospital

Name Role Affiliation
Paul Rosenberg Principal Investigator Johns Hopkins University
Brent Forester Principal Investigator McLean Hospital

Name Phone Email
John Outen, M.S. 410-550-7385 jouten3@jhmi.edu
Patrick Monette 617-855-2591 pmonette@mclean.harvard.edu

NCT02792257

Pilot Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease (AD) (THC-AD)