Overview

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

Status:
Recruiting

Trial end date:
2023-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Johns Hopkins University
Paul B. Rosenberg

Collaborators:

Mclean Hospital
Miami Jewish Health

Treatments:

Dronabinol

Criteria

Inclusion Criteria:

1. Diagnosis of Dementia due to AD

2. 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.

3. Clinically significant severity of agitation defined by NPI-C Agitation or NPI-C
Aggression > 4.

4. Able to give informed consent, or deemed to lack such capacity by clinical team and
legally authorized representative consents.

5. Must be fluent in English and/or Spanish (includes reading, writing, and speech)

6. 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.

7. Must be 60-95 years old

8. Must begin enrollment in study within one week of being determined eligible

Exclusion Criteria:

1. Serious or unstable medical illness, including cardiovascular, hepatic, renal,
respiratory, endocrine, neurologic or hematologic disease, which might confound
assessment of safety outcomes.

2. Seizure disorder

3. Baseline delirium as determined by Confusion Assessment Method (CAM) and Diagnostic
and Statistical Manual of Mental Disorders (DSM) -5 criteria

4. Current use of lithium

5. Inability to swallow a pill