BACKGROUND: Behavioral disturbances and psychological symptoms of dementia--such as agitation, aggression, and psychosis--compromise patients' quality of life and daily functioning as well as contribute to caregiver burden and the decision to institutionalize the relative with the disease. OBJECTIVE: The goal of this study was to examine the effects of risperidone on noncognitive symptoms and caregiver burden in the community setting. The tolerability of risperidone was also assessed. METHODS: This was an observational, open-label, multicenter study. Dementia patients with behavioral and psychological symptoms received risperidone for 3 months. At 1 and 3 months, physicians rated symptoms on the Neuropsychiatric Inventory (NPI) and the Clinical Global Impression of Severity (CGI-S) scale. Caregivers rated their distress in relation to individual NPI items using the NPI Caregiver Distress (NPI-D) scale. Outcome variables were analyzed using Friedman and Wilcoxon tests. RESULTS: A total of 263 patients (mean age, 77.5 years) received a mean (SD) risperidone dose of 1.4 (0.7) mg/d at 1 month and 1.5 (0.8) mg/d at 3 months. The total NPI score (mean [SEM]) decreased from 33.7 (1.91) at baseline to 11.9 (0.98) at month 3 (P < 0.01), and the NPI-D score decreased from 22.5 (1.02) at baseline to 9.0 (0.64) at month 3 (P < 0.01). Agitation/aggression and sleep disturbances were the most improved symptoms and caused the largest decrease in caregiver burden. Improvements were also noted on the CGI-S scale (from 4.0 at baseline to 3.4 at month 3; P < 0.01). Extrapyramidal symptoms decreased significantly (P < 0.05) over the course of the study. CONCLUSIONS: In this study of community-based patients with dementia, risperidone significantly improved behavioral and psychological symptoms and, as a result, also reduced caregiver burden. Risperidone was well tolerated in this elderly population, particularly with regard to extrapyramidal symptoms.
BACKGROUND:Behavioral disturbances and psychological symptoms of dementia--such as agitation, aggression, and psychosis--compromise patients' quality of life and daily functioning as well as contribute to caregiver burden and the decision to institutionalize the relative with the disease. OBJECTIVE: The goal of this study was to examine the effects of risperidone on noncognitive symptoms and caregiver burden in the community setting. The tolerability of risperidone was also assessed. METHODS: This was an observational, open-label, multicenter study. Dementiapatients with behavioral and psychological symptoms received risperidone for 3 months. At 1 and 3 months, physicians rated symptoms on the Neuropsychiatric Inventory (NPI) and the Clinical Global Impression of Severity (CGI-S) scale. Caregivers rated their distress in relation to individual NPI items using the NPI Caregiver Distress (NPI-D) scale. Outcome variables were analyzed using Friedman and Wilcoxon tests. RESULTS: A total of 263 patients (mean age, 77.5 years) received a mean (SD) risperidone dose of 1.4 (0.7) mg/d at 1 month and 1.5 (0.8) mg/d at 3 months. The total NPI score (mean [SEM]) decreased from 33.7 (1.91) at baseline to 11.9 (0.98) at month 3 (P < 0.01), and the NPI-D score decreased from 22.5 (1.02) at baseline to 9.0 (0.64) at month 3 (P < 0.01). Agitation/aggression and sleep disturbances were the most improved symptoms and caused the largest decrease in caregiver burden. Improvements were also noted on the CGI-S scale (from 4.0 at baseline to 3.4 at month 3; P < 0.01). Extrapyramidal symptoms decreased significantly (P < 0.05) over the course of the study. CONCLUSIONS: In this study of community-based patients with dementia, risperidone significantly improved behavioral and psychological symptoms and, as a result, also reduced caregiver burden. Risperidone was well tolerated in this elderly population, particularly with regard to extrapyramidal symptoms.