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

Abstract

OBJECTIVE:

The objective of this study was to evaluate efficacy and safety of low-dose risperidone for treating psychosis of Alzheimer disease (AD).

METHOD:

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.

RESULTS:

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 +/- 0.24 mg per day. All-cause discontinuation rates were 25% for both risperidone and placebo. Treatment-emergent adverse events occurred in 74% risperidone versus 64% placebo patients, with somnolence occurring significantly more frequently with risperidone (16.2% versus 4.6%). Nine (3.8%) risperidone- and six (2.5%) placebo patients died during or within 30 days after treatment.

CONCLUSION:

This trial did not confirm earlier findings in this population.

• Authors: Jacobo Mintzer, Andrew Greenspan, Ivo Caers, Ilse Van Hove, Stuart Kushner, Myron Weiner, Georges Gharabawi, Lon S Schneider
• Journal: The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry (Am J Geriatr Psychiatry) Vol. 14 Issue 3 Pg. 280-91 (Mar 2006) ISSN: 1064-7481 [Print] England
• PMID: 16505133 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antipsychotic Agents
• Risperidone

Topics

• Aged
• Aged, 80 and over
• Alzheimer Disease (diagnosis, drug therapy, psychology)
• Antipsychotic Agents (adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Long-Term Care
• Male
• Middle Aged
• Nursing Homes
• Prospective Studies
• Psychotic Disorders (diagnosis, drug therapy, psychology)
• Risperidone (adverse effects, therapeutic use)