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.