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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT02792257

Run by

Johns Hopkins University

People needed

84

Starts

2017-03-01

Expected to finish

2024-05-31

Last updated by the study team

2025-05-09

Who can join

Age: 60 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Dementia due to AD
• Presence of Agit-AD as defined by the provisional criteria from the International Psychogeriatric Association (IPA). The definition requires the presence of cognitive impairment, evidence of emotional distress, one of three observable types of behavior (excessive motor activity, verbal aggression, physical aggression), requires that the behavior cause excess disability, and notes that the behaviors cannot be solely attributable to another disorder such as psychiatric illness, medical illness, or effects of substance use.
• Clinically significant severity of agitation defined by NPI-C Agitation or NPI-C Aggression > 4.
• Able to give informed consent, or deemed to lack such capacity by clinical team and legally authorized representative consents.
• Must be fluent in English and/or Spanish (includes reading, writing, and speech)
• 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.
• Must be 60-95 years old
• Must begin enrollment in study within one week of being determined eligible

You may not qualify if…

• Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
• Seizure disorder
• Baseline delirium as determined by Confusion Assessment Method (CAM) and Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 criteria
• Current use of lithium
• Inability to swallow a pill

Where it is running

• Miami Jewish Health — Miami, Florida, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• McLean Hospital — Belmont, Massachusetts, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• North Shore Medical Center — Salem, Massachusetts, United States

Full record on ClinicalTrials.gov

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