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Risperidone for psychosis of Alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial

✍ Scribed by Henry Brodaty; David Ames; John Snowdon; Michael Woodward; Jeff Kirwan; Roger Clarnette; Emma Lee; Andrew Greenspan

Publisher: John Wiley and Sons
Year: 2005
Tongue: English
Weight: 86 KB
Volume: 20
Category: Article
ISSN: 0885-6230
DOI: 10.1002/gps.1409

No coin nor oath required. For personal study only.

✦ Synopsis

Objective:

To evaluate the efficacy and safety of low-dose risperidone in treating psychosis of alzheimer's disease (ad) and mixed dementia (md) in a subset of nursing-home residents who had dementia and aggression and who were participating in a randomized placebo-controlled trial of risperidone for aggression.

Method:

This post-hoc analysis included only patients diagnosed with ad or md with psychosis, defined by a score of >or= 2 on any item of the behavioral pathology of alzheimer's disease (behave-ad) psychosis subscale at both screening and baseline. co-primary efficacy endpoints were changes in scores on behave-ad psychosis subscale and clinical global impression of change (cgi-c).

Results:

Overall, 93 patients (46 risperidone and 47 placebo) fulfilled the psychosis of ad criteria. mean change at endpoint in behave-ad psychosis subscale with risperidone was superior to placebo (-5.2 vs -3.3; p = 0.039). distribution of cgi-c at endpoint also favoured risperidone (p < 0.001). the superior improvement with risperidone compared with placebo occurred as early as the first two weeks and persisted to the end of the treatment period. at endpoint, 59% of risperidone-treated patients were responders (i.e. were 'very much' or 'much' improved) compared with 26% of patients receiving placebo. the mean risperidone dose was 1.03 +/- 0.61 mg/day. twelve weeks of treatment were completed by 37 patients treated with risperidone (80%) and 35 with placebo (74%). a total of 46 (98%) placebo- and 44 (96%) risperidone-treated patients experienced at least one adverse event, with only somnolence occurring more frequently in the risperidone group.

Conclusion:

Risperidone effectively reduces psychosis and improves global functioning in elderly patients with moderate-to-severe psychosis of ad and md.

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