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The efficacy and safety of risperidone in the treatment of psychosis of Alzheimer's disease and mixed dementia: a meta-analysis of 4 placebo-controlled clinical trials.
Int J Geriatr Psychiatry. 2007 May; 22(5):475-84.IJ

Abstract

BACKGROUND

Dementia typically includes behavioral and psychological symptoms of dementia (BPSD) as well as cognitive decline. Psychosis of Alzheimer's disease (AD) is a specific component of AD, characterized by delusions, misidentifications, and hallucinations.

METHODS

This study is a meta-analysis of patients with psychosis of AD from four large placebo-controlled clinical trials of risperidone in dementia. Three trials included patients diagnosed with heterogeneous symptoms of BPSD (those with psychosis of AD were included in this analysis), while one trial included only those diagnosed with psychosis of AD. Efficacy was measured using the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression (CGI).

RESULTS

Primary analyses in the psychosis of AD population demonstrated that risperidone significantly improved scores on the BEHAVE-AD Psychosis subscale and CGI scale compared with placebo. Secondary analyses demonstrated that patients with more severe symptoms showed a more pronounced response to treatment with risperidone compared with placebo than those patients with less severe symptoms. Extrapyramidal symptoms and somnolence were more frequent with risperidone than placebo (p=0.04). Cerebrovascular adverse events and all-cause mortality were observed more frequently, although not statistically significantly, with risperidone versus placebo.

CONCLUSIONS

This meta-analysis of psychosis of AD showed improvement in psychotic symptoms and general clinical improvement in patients with psychosis of AD treated with risperidone compared with placebo. The benefits of treatment were most significant in patients with severe symptoms. The safety profile of risperidone in this psychosis of AD population was similar to the more general BPSD population.

Authors+Show Affiliations

Katz I
Department of Psychiatry, University of Pennsylvania, Philadelphia, PA 19104, USA, and Department of Neurology, Memory Clinic, Middelheim Hospital, ZNA, Wilrijk-Antwerp, Belgium. katzi@mail.med.upenn.edu
de Deyn PP
No affiliation info available
Mintzer J
No affiliation info available
Greenspan A
No affiliation info available
Zhu Y
No affiliation info available
Brodaty H
No affiliation info available

MeSH

AgedAged, 80 and overAlzheimer DiseaseAntipsychotic AgentsDementiaDouble-Blind MethodFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPsychiatric Status Rating ScalesPsychotic DisordersRandomized Controlled Trials as TopicRisperidoneTreatment Outcome

Pub Type(s)

Journal Article
Meta-Analysis

Language

eng

PubMed ID

17471598

Clinical Trial Links

Treatment of Psychosis and Agitation in Alzheimer's Disease

Citation

Katz, Ira, et al. "The Efficacy and Safety of Risperidone in the Treatment of Psychosis of Alzheimer's Disease and Mixed Dementia: a Meta-analysis of 4 Placebo-controlled Clinical Trials." International Journal of Geriatric Psychiatry, vol. 22, no. 5, 2007, pp. 475-84.
Katz I, de Deyn PP, Mintzer J, et al. The efficacy and safety of risperidone in the treatment of psychosis of Alzheimer's disease and mixed dementia: a meta-analysis of 4 placebo-controlled clinical trials. Int J Geriatr Psychiatry. 2007;22(5):475-84.
Katz, I., de Deyn, P. P., Mintzer, J., Greenspan, A., Zhu, Y., & Brodaty, H. (2007). The efficacy and safety of risperidone in the treatment of psychosis of Alzheimer's disease and mixed dementia: a meta-analysis of 4 placebo-controlled clinical trials. International Journal of Geriatric Psychiatry, 22(5), 475-84.
Katz I, et al. The Efficacy and Safety of Risperidone in the Treatment of Psychosis of Alzheimer's Disease and Mixed Dementia: a Meta-analysis of 4 Placebo-controlled Clinical Trials. Int J Geriatr Psychiatry. 2007;22(5):475-84. PubMed PMID: 17471598.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy and safety of risperidone in the treatment of psychosis of Alzheimer's disease and mixed dementia: a meta-analysis of 4 placebo-controlled clinical trials. AU - Katz,Ira, AU - de Deyn,Peter-Paul, AU - Mintzer,Jacobo, AU - Greenspan,Andrew, AU - Zhu,Young, AU - Brodaty,Henry, PY - 2007/5/2/pubmed PY - 2007/12/13/medline PY - 2007/5/2/entrez SP - 475 EP - 84 JF - International journal of geriatric psychiatry JO - Int J Geriatr Psychiatry VL - 22 IS - 5 N2 - BACKGROUND: Dementia typically includes behavioral and psychological symptoms of dementia (BPSD) as well as cognitive decline. Psychosis of Alzheimer's disease (AD) is a specific component of AD, characterized by delusions, misidentifications, and hallucinations. METHODS: This study is a meta-analysis of patients with psychosis of AD from four large placebo-controlled clinical trials of risperidone in dementia. Three trials included patients diagnosed with heterogeneous symptoms of BPSD (those with psychosis of AD were included in this analysis), while one trial included only those diagnosed with psychosis of AD. Efficacy was measured using the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) Psychosis subscale and Clinical Global Impression (CGI). RESULTS: Primary analyses in the psychosis of AD population demonstrated that risperidone significantly improved scores on the BEHAVE-AD Psychosis subscale and CGI scale compared with placebo. Secondary analyses demonstrated that patients with more severe symptoms showed a more pronounced response to treatment with risperidone compared with placebo than those patients with less severe symptoms. Extrapyramidal symptoms and somnolence were more frequent with risperidone than placebo (p=0.04). Cerebrovascular adverse events and all-cause mortality were observed more frequently, although not statistically significantly, with risperidone versus placebo. CONCLUSIONS: This meta-analysis of psychosis of AD showed improvement in psychotic symptoms and general clinical improvement in patients with psychosis of AD treated with risperidone compared with placebo. The benefits of treatment were most significant in patients with severe symptoms. The safety profile of risperidone in this psychosis of AD population was similar to the more general BPSD population. SN - 0885-6230 UR - https://www.unboundmedicine.com/medline/citation/17471598/The_efficacy_and_safety_of_risperidone_in_the_treatment_of_psychosis_of_Alzheimer's_disease_and_mixed_dementia:_a_meta_analysis_of_4_placebo_controlled_clinical_trials_ DB - PRIME DP - Unbound Medicine ER -