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Clinical Conference Psychosis of Alzheimer disease: validity of the construct and response to risperidone. 2003
Schneider LS, Katz IR, Park S, Napolitano J, Martinez RA, Azen SP. · University of Southern California, Keck School of Medicine, Department of Psychiatry, Los Angeles, CA 90033, USA. · Am J Geriatr Psychiatry. · Pubmed #12837670 No free full text.
Abstract: OBJECTIVE: The authors evaluated the efficacy of risperidone in reducing psychotic and aggressive symptoms in a subgroup of patients who fulfilled operationalized criteria for psychosis of dementia. METHODS: Authors conducted a subgroup analysis of patients in the risperidone database arising from a previous double-blind, randomized, placebo-controlled study. In the primary study, patients age 55 or older, with a DSM-IV diagnosis of Alzheimer disease and/or vascular dementia were randomized to placebo or 0.5 mg, 1.0 mg, or 2.0 mg/day of risperidone. For this analysis, patients were selected who fulfilled operationalized criteria for psychosis of dementia. These criteria were then validated. The primary outcome measures were the newly developed Psychosis and Aggression Severity Indices, derived from Parts 1 and 2 of the BEHAVE-AD rating scale. RESULTS: At Week 12 and endpoint, patients with psychosis of dementia receiving 1 mg or 2 mg/day of risperidone showed significantly more improvement on the Psychosis Severity and Aggressiveness Severity Indices than those receiving placebo. CONCLUSIONS: The construct of psychosis of dementia was validated, and the severity of both psychosis and aggressiveness was reduced with risperidone treatment in a robust and dose-related way, with a continuing response over the 12-week trial period.
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Clinical Conference Low incidence of persistent tardive dyskinesia in elderly patients with dementia treated with risperidone. free! 2000
Jeste DV, Okamoto A, Napolitano J, Kane JM, Martinez RA. · Geriatric Psychiatry Intervention Research Center, University of California San Diego, USA. · Am J Psychiatry. · Pubmed #10873925 links to free full text
Abstract: OBJECTIVE: The authors studied the incidence of tardive dyskinesia in elderly institutionalized patients with dementia being treated with risperidone. METHOD: After participating in a 12-week multicenter double-blind study during which they received placebo or one of three doses of risperidone, 330 patients (mean age=82.5 years) with Alzheimer's, vascular, or mixed dementia were enrolled in a 1-year open-label study during which they received flexible doses of risperidone. Persistent emergent tardive dyskinesia was defined according to scores on the dyskinesia subscale of the Extrapyramidal Symptom Rating Scale. RESULTS: The mean modal risperidone dose was 0.96 mg/day (SD=0.53), and the median length of risperidone use was 273 days. The 1-year cumulative incidence of persistent emergent tardive dyskinesia among the 255 patients without dyskinesia at baseline was 2.6%. Patients with dyskinetic symptoms at baseline experienced significant reductions in the severity of dyskinesia. Patients who received 0.75-1.5 mg/day of risperidone showed a significant improvement in psychopathologic symptoms over the 1-year period. CONCLUSIONS: Although there was no control group, the observed incidence of persistent tardive dyskinesia with risperidone seemed to be much lower than that seen in elderly patients treated with conventional neuroleptics. The average optimal dose of risperidone in elderly dementia patients was found to be 0.75-1.5 mg/day.
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Article Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. free! 2002
Wendler D, Martinez RA, Fairclough D, Sunderland T, Emanuel E. · Department of Clinical Bioethics, Warren G. Magnuson Clinical Center, National Institutes of Health, Bethesda, MD 20892-1156, USA. · Am J Psychiatry. · Pubmed #11925296 links to free full text
Abstract: OBJECTIVE: The authors' goal was to assess healthy individuals' attitudes toward five of the most prominent proposed safeguards regarding the consent process for research with adults unable to consent. METHOD: Telephone interviews were conducted with 246 individuals with a family history of Alzheimer's disease who had participated in clinical research. RESULTS: The majority of respondents said that they were willing to participate in research if they lost the ability to consent. Few completed a research advance directive. Many had discussed their preferences with their families, and the majority would allow their families to make research decisions for them. CONCLUSIONS: Enrolling individuals who are unable to consent in research that offers no potential for medical benefit is consistent with the preferences of at least some individuals. This suggests that such research should not be prohibited, provided there is sufficient evidence that it is consistent with the preferences of individual subjects. Requiring that such evidence be provided in a formal research advance directive may be unnecessarily restrictive. More research is needed to assess whether the findings in this group of subjects generalize to other groups.
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