Risperidone in the treatment of psychosis of Alzheimer disease: results from a prospective clinical trial

The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry
Jacobo MintzerLon S Schneider

Abstract

The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease (AD). The authors conducted a randomized, eight-week, double-blind, placebo-controlled, multicenter trial involving nursing home residents diagnosed with AD and psychosis. Four hundred seventy-three patients were randomly assigned to placebo (N = 238) or 1.0 to 1.5 mg risperidone per day (N = 235). Coprimary efficacy end points were: changes in scores on the Behavioral pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression of Change (CGI-C). Protocol-specified subgroup analyses were performed by demographics and dementia severity. Efficacy analysis included 416 patients. Both groups improved significantly on the BEHAVE-AD Psychosis subscale and CGI-C with no significant difference between groups. In the subgroups analyses, a statistically significant treatment by Mini-Mental Status Examination (MMSE) interaction on the CGI-C (F([2,381]) = 3.90, p = 0.021) was observed with patients with more severe dementia (MMSE <10) showing significant differences at end point favoring risperidone treatment (chi(2) ([1]) = 5.11, p = 0.024). Mean risperidone dose was 1.03 +/...Continue Reading

References

Dec 12, 2001·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·T Laughren
Jul 3, 2003·The American Journal of Geriatric Psychiatry : Official Journal of the American Association for Geriatric Psychiatry·Lon S SchneiderStanley P Azen

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