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Title Pilot trial of dronabinol adjunctive treatment of agitation in Alzheimer’s disease (AD) (THC-AD)
Therapeutic Area Alzheimer's Disease, Dementia, Psychotic Disorders, Mental Disorders
Principal Investigator Brent P. Forester MD, MSc
Min Age 60 Years
Max Age 95 Years
Gender Any
Contact Todd Laffaye
(617) 855-5380
More Information


This research study is a 3-week clinical trial of dronabinol, a synthetic form of tetrahydrocannabinol (THC). This study is being done to determine if dronabinol is a safe and effective treatment for agitation symptoms related to Alzheimer’s disease. This study will compare dronabinol to a placebo.

Study Details

Inclusion Criteria

- Must speak English and/or Spanish (includes reading, writing, and speech) - Have a diagnosis of Dementia due to Alzheimer's disease - Have agitation symptoms defined clinically 

Exclusion Criteria

 Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematological disease - Seizure disorder - Current prescription of lithium

Study Requirements

Participants will be given an investigational drug and asked to come for 5 study visits. Participants will complete screening questionaries at the first study visit before receiving the investigational drug. Participants will complete more questionnaires at later study visits. Participants will also receive a physical examination, neurological examination, electrocardiogram (ECG), and give a total of 2 blood samples. We expect the total duration of this research study to be 3 weeks.