Objective: To study the antipsychotic effects of risperidone versus placebo in treating behavioral and psychological symptoms of dementia (BPSD) in nursing-home residents with psychosis of Alzheimer’s disease and related dementias.
Materials and Methods: Data from three, 12-week, double-blind, placebo-controlled, clinical trials were pooled (n = 1150). The mean risperidone dose in this patient population was 1.0 mg/day. BPSD were evaluated at baseline and at weeks 4, 8 and 12 in a subgroup of patients who were psychotic at baseline [defined as a score of ³2 on any delusion or hallucination item of the Behavioural Pathology in Alzheimer’s Disease (BEHAVE-AD) scale]. Of this population, 687 (59.7%) patients were scored as having baseline psychosis. Patients were randomized to receive either placebo (n=253) or risperidone (n=434). Efficacy was measured using the BEHAVE-AD total and psychotic symptom subscale (combined delusion and hallucination items), and the Clinical Global Impression of Change (CGI-C).
Results: There was no apparent difference between treatment groups in the BEHAVE-AD total baseline scores (mean: 19.7±0.39 and 20.0±0.52 for risperidone and placebo, respectively). A significantly greater improvement was observed for risperidone compared with placebo, beginning at week 4 and continuing throughout treatment (week 8 and 12, P<0.001). The mean reductions from baseline to endpoint in the scores on the BEHAVE-AD psychotic symptom subscale were significantly greater for patients in the risperidone group compared with those in the placebo group (baseline: 7.2 for both groups, mean change from baseline: -3.5±0.21 vs. -2.1±0.32, respectively; P=0.003). For the BEHAVE-AD delusions scale a significant improvement for patients in the risperidone group compared with those in the placebo group was observed (baseline: 5.6 and 5.4, respectively, mean change from baseline: -2.8±017 vs. -1.9±0.25, respectively; P=0.002). No significant changes were observed on the BEHAVE-AD hallucination item (baseline 1.6 and 1.8, respectively, change from baseline -0.7±0.1 vs. -0.6±0.1, respectively; P=0.24), which is probably due to the low baseline scores. The change in CGI-C ratings from baseline to endpoint, as scored by both the investigator and caregiver, indicated a significantly greater improvement in the risperidone-treated group compared with the placebo group (P<0.001 for each). At endpoint investigators (and caregivers) rated 63.6% (61.1%) of risperidone and 43.9% (40.5%) of placebo-treated patients as improved (rating of 1, 2, or 3) and 15.6% (22.3%) of risperidone and 27.3% (36.6%) of placebo-treated patients as worsened (rating of 5, 6, or 7).
Conclusion: Risperidone is effective at low doses in reducing psychotic symptoms in elderly patients with psychosis of Alzheimer’s Disease and related dementias.
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