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More than 80 percent of caregivers report they frequently experience high levels of stress, and nearly half say they suffer from depression, according to the Alzheimer's Association.

The Phase II, open label, randomized, parallel-group study involved 54 community-dwelling patients at two sites, all who demonstrated behavioral agitation (mean age = 81). All patients were over the age of 50 years and met DSM-IV criteria for dementia related to Alzheimer's. The Mini-Mental State Exam (MMSE) and the Cohen-Mansfield Agitation Inventory (CMAI) were used to measure severity of Alzheimer's disease and agitation level, respectively. Following a one-week qualifying period to evaluate the degree of agitation, patients were screened on Day 0, evenly randomized to one of two treatment groups (dronabinol 2.5 mg bid or dronabinol 5 mg bid) on Day 7, and returned for clinic visits on Day 21, Day 35 and Day 63. The primary efficacy measurement was the CMAI, a 38-item rating scale that evaluates the prevalence of pathological and disruptive behaviors. The secondary efficacy measurements were the Caregiver's Burden Inventory (CBI), CGI Severity of Alzheimer's disease (CGI-S AD), Instrumental Activities of Daily Living Scale (IADL) and MMSE. Evaluation at nine weeks found significant reductions of CMAI scores in both groups. There also was a trend toward a decrease in CBI scores and increase in IADL scores in both groups, without a statistical difference between the two doses. The 5 mg bid group experienced a trend toward a decrease in CGI-S AD scores.

Doses could be adjusted during the study, allowing for a patient to receive both doses of the medication and be included in both groups at the time of evaluation for efficacy and adverse events. Adverse events experienced by more the five percent of patients involved in the study included abnormal gait, accidental injury, agitation, anxiety, asthenia, dizziness, somnolence, spontaneous bone fra
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14-Nov-2003