Dronabinol for Agitation in Alzheimer's Disease (THC-AD Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen ByPaul Rosenberg

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Johns Hopkins University

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing Dronabinol, a synthetic form of THC, to see if it can help reduce severe agitation in Alzheimer's patients. The drug works by targeting brain receptors to reduce anxiety, depression, and inflammation. This could provide a new treatment option for a challenging symptom of Alzheimer's disease. Dronabinol has been previously reported as a potential treatment for neuropsychiatric symptoms in dementia, including agitation and aggressive behavior.

Eligibility Criteria

This trial is for adults aged 60-95 with Alzheimer's Disease who experience significant agitation. Participants must be inpatients or able to visit certain hospitals, and fluent in English/Spanish. Those with serious illnesses, seizure disorders, delirium, or unable to swallow pills cannot join.

Inclusion Criteria

I have been diagnosed with agitation related to Alzheimer's disease.

I experience severe agitation or aggression.

I am between 60 and 95 years old.

I can be at McLean, Johns Hopkins, or Miami Jewish Health for 3 weeks.

I have been diagnosed with Alzheimer's disease.

Exclusion Criteria

I do not have any serious illnesses that could affect the study's safety assessment.

I have a seizure disorder.

I have been diagnosed with delirium.

I am currently taking lithium.

I cannot swallow pills.

Participant Groups

The study tests Dronabinol (Marinol®), a potential treatment for agitation in Alzheimer's patients, against a placebo. It aims to determine if Dronabinol can safely reduce agitation symptoms and improve quality of life.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DronabinolExperimental Treatment1 Intervention

Study medication will be administered twice daily. Capsules of dronabinol will contain 2.5 mg per dose (5mg daily) during Week 1, then increase to 5 mg per dose (10mg daily) for Weeks 2 and 3.

Group II: PlaceboPlacebo Group1 Intervention

Placebo medication will be administered twice daily.