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

Other illness

• 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

Other

• Current use of lithium
• Inability to swallow a pill

• 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