Randomized, Placebo-Controlled, Clinical Trial of Donepezil in Vascular Dementia
| Autor: | Rachel Schindler, Sandra E. Black, Gustavo C. Román, Margaret Moline, Charles DeCarli, Donald R. Royall, Stephen Salloway, Michael Weiner, Holly Posner, Dinesh Kumar |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Population Placebo Hippocampus Article law.invention Cognition Double-Blind Method Piperidines Randomized controlled trial law Internal medicine medicine Humans Dementia Donepezil Vascular dementia Psychiatry education Nootropic Agents Aged Aged 80 and over Advanced and Specialized Nursing education.field_of_study business.industry Dementia Vascular Organ Size Middle Aged medicine.disease Differential effects Radiography Clinical trial Indans Female Neurology (clinical) Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | Stroke. 41:1213-1221 |
| ISSN: | 1524-4628 0039-2499 |
| DOI: | 10.1161/strokeaha.109.570077 |
| Popis: | Background and Purpose— We sought to assess the efficacy and safety of donepezil in patients with vascular dementia (VaD) fulfilling National Institute of Neurological Disorders and Stroke–Association Internationale pour la Recherche et l’Enseignement en Neurosciences criteria. Methods— This international, multicenter, 24-week trial was conducted from March 2003 to August 2005. Patients (N=974; mean age, 73.0 years) with probable or possible VaD were randomized 2:1 to receive donepezil 5 mg/d or placebo. Coprimary outcome measures were scores on the Vascular-Alzheimer Disease Assessment Scale–Cognitive Subscale and Clinician’s Interview–Based Impression of Change, plus carer interview. Analyses were performed for the intent-to-treat population with the last-observation-carried-forward method. Results— Compared with placebo, donepezil-treated patients showed significant improvement from baseline to end point on the Vascular-Alzheimer Disease Assessment Scale–Cognitive Subscale (least-squares mean difference, −1.156; 95% CI, −1.98 to −0.33; P Conclusions— Patients treated with donepezil 5 mg/d demonstrated significant improvement in cognitive, but not global, function. Donepezil was relatively well tolerated; adverse events were consistent with current labeling. Mortality in the placebo group was unexpectedly low. The differential treatment response of VaD patients by hippocampal size suggests that hippocampal imaging warrants further investigation for understanding VaD. |
| Databáze: | OpenAIRE |
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