OBJECTIVES

To examine the effect of risperidone on specific behavioral and psychological symptoms of dementia (BPSD) among patients with psychosis of Alzheimer's disease (AD).

METHODS

Post hoc exploratory analysis of data on 479 nursing-home patients with psychosis of AD from three 12-week, double-blind, placebo-controlled clinical trials. Criteria for psychosis of AD were a diagnosis of AD or mixed dementia and a rating of >/= 2 on any delusion or hallucination item of the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) rating scale when entering the trial. Mean changes from baseline to endpoint were examined for items on the Cohen-Mansfield Agitation Inventory (CMAI) and BEHAVE- AD.

RESULTS

On the CMAI, risperidone was significantly more effective than placebo in treating cursing or verbal aggression (p = 0.004), hitting (p < 0.001), performing repetitious mannerisms (p < 0.001), pacing, aimless wandering (p = 0.017), hoarding things (p = 0.02), hiding things (p = 0.02) and repetitive sentences or questions (p = 0.025). On the BEHAVE-AD, risperidone was significantly more effective than placebo in treating physical threats and/or violence (p = 0.001), agitation (other) (p = 0.001) and verbal outbursts (p = 0.026). Although analysis on individual hallucination and delusional items did not demonstrate specific responses, analyses of a composite of delusional items revealed significant drug-placebo differences.

CONCLUSIONS

These data indicate that risperidone is effective in treating a variety of symptoms associated with psychosis of AD.