Objective: To evaluate the efficacy and safety of aripiprazole in patients with psychosis of Alzheimer’s disease (AD).
Design: A 10-week multicenter randomized double-blind placebo-controlled trial.
Methods: 208 outpatients with psychotic symptoms associated with AD (mean age 81.5y, baseline MMSE = 13.6) were randomized to placebo or flexible doses of aripiprazole, initiated at 2 mg/day for 2 weeks, with option to increase to 15 mg/day. Efficacy was assessed by Neuropsychiatric Inventory (NPI) Psychosis subscale and Brief Psychiatric Rating Scale (BPRS).
Results: Mean dose of aripiprazole was 10 mg/day (range 1–17 mg). At week 10, NPI Psychosis score (mean baseline 12.3 aripiprazole and 12.1 placebo) was improved with both aripiprazole and placebo (–6.55 vs –5.52, P=0.17). Patients treated with aripiprazole experienced improvement in the BPRS Total score and a significant improvement in BPRS Psychosis (hallucinations and delusions) subscore compared with placebo (–1.93 vs –1.27, P=0.03). Discontinuation rates due to adverse events were 10% with aripiprazole and 7% with placebo. Somnolence was mild and not associated with falls or accidental injury. There were no significant differences in ECG abnormalities, vital signs, labs, or weight.
Conclusion: Aripiprazole improved symptoms of hallucinations and delusions in community-living AD patients. Aripiprazole was well tolerated in this elderly population.
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