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Dronabinol to Treat Agitation in Alzheimer's Disease

Start: March 1, 2017
End: May 2023
Enrollment: 160

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?

Minimum Age: 60 Years

Maximum Age: 95 Years

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.

Study Contact
John Outen, M.S.
Eleanor Ash, B.A.

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Miami Jewish Health
Miami, FL 33137
Maria Isesalaya, MBA, BS
Johns Hopkins University
Baltimore, MD 21224
John Outen, M.S.
McLean Hospital
Belmont, MA 02478
Eleanor Ash, B.A.

Who Sponsors This Study?

Lead: Johns Hopkins University

Collaborator Sponsor

  • McLean Hospital

Source: ID: NCT02792257