Objective: to investigate the safety and efficacy of dronabinol in Alzheimer’s disease (AD) patients with agitation.
Design: retrospective review.
Materials and Methods: AD patients with anorexia, where according to family members or caregivers (staff nurses) agitation was not satisfactorily controlled, were prescribed dronabinol. All met the DSM-IV & NINCDS-ADRDA criteria for possible AD. There were no exclusion criteria. Study subjects resided in a dementia unit in assistant living facility and in a nursing home. Dronabinol, 5 mg/day in 2 divided doses was given initially & titrated up to a maximum of 10 mg/day. Cognition and function evaluated at the start and end of the study period. MMSE and ADL scales used for assessment. Concomitant medications were recorded. After 1 month of treatment, caregivers were asked to complete a questionnaire regarding their impression on treatment efficacy.
Results: 48 patients were treated with dronabinol. Average age was 77. Average MMSE was 16. All patients were treated with atypical neuroleptics. All were treated with multiple (greater than 3) medications to control behavior. All patients had diagnoses of anorexia prior to initiation of dronabinol therapy. Weight gain was reported in all patients. Agitation significantly improved in 31 (65%). In 14 (37%) there was improvement in MMSE score (average increase by 1.6 points (range +1 to +3). Functional improvement was reported in 33 (69%). 17 (35%) patients had no significant beneficial effect with regard to agitation, and their medication was discontinued within 2 weeks of initiation of treatment. No patient experienced any significant adverse event (falls, syncope, seizures or exacerbation of agitation/depression).
Conclusion: Dronabinol treatment for agitation in AD patients with anorexia was effective in 31 out of 48 of patients who were refractory to other medications. No adverse events were reported.
