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Risperidone for psychosis of Alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial.
Int J Geriatr Psychiatry. 2005 Dec; 20(12):1153-7.IJ

Abstract

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.

Authors+Show Affiliations

Academic Department of Psychogeriatrics, School of Psychiatry, University of New South Wales, Sydney, Australia. h.brodaty@unsw.edu.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16315159

Citation

Brodaty, Henry, et al. "Risperidone for Psychosis of Alzheimer's Disease and Mixed Dementia: Results of a Double-blind, Placebo-controlled Trial." International Journal of Geriatric Psychiatry, vol. 20, no. 12, 2005, pp. 1153-7.
Brodaty H, Ames D, Snowdon J, et al. Risperidone for psychosis of Alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial. Int J Geriatr Psychiatry. 2005;20(12):1153-7.
Brodaty, H., Ames, D., Snowdon, J., Woodward, M., Kirwan, J., Clarnette, R., Lee, E., & Greenspan, A. (2005). Risperidone for psychosis of Alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial. International Journal of Geriatric Psychiatry, 20(12), 1153-7.
Brodaty H, et al. Risperidone for Psychosis of Alzheimer's Disease and Mixed Dementia: Results of a Double-blind, Placebo-controlled Trial. Int J Geriatr Psychiatry. 2005;20(12):1153-7. PubMed PMID: 16315159.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risperidone for psychosis of Alzheimer's disease and mixed dementia: results of a double-blind, placebo-controlled trial. AU - Brodaty,Henry, AU - Ames,David, AU - Snowdon,John, AU - Woodward,Michael, AU - Kirwan,Jeff, AU - Clarnette,Roger, AU - Lee,Emma, AU - Greenspan,Andrew, PY - 2005/11/30/pubmed PY - 2006/5/26/medline PY - 2005/11/30/entrez SP - 1153 EP - 7 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 20 IS - 12 N2 - 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. SN - 0885-6230 UR - https://www.unboundmedicine.com/medline/citation/16315159/Risperidone_for_psychosis_of_Alzheimer's_disease_and_mixed_dementia:_results_of_a_double_blind_placebo_controlled_trial_ L2 - https://doi.org/10.1002/gps.1409 DB - PRIME DP - Unbound Medicine ER -