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Donepezil in vascular dementia: a randomized, placebo-controlled study.

D Wilkinson·R Doody·R Helme·K Taubman·J Mintzer·A Kertesz·R D Pratt·Donepezil 308 Study Group
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Abstract

OBJECTIVE: To evaluate the efficacy and tolerability of donepezil in patients with vascular dementia (VaD). METHODS: Patients (n = 616; mean age, 75.0 years) with probable or possible VaD, according to National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche en l'Enseignement en Neurosciences criteria, were randomized to receive donepezil 5 mg/day (n = 208), donepezil 10 mg/day (after 5 mg/day for the first 28 days) (n = 215), or placebo (n = 193) for 24 weeks. RESULTS: Seventy-six percent of the patients enrolled had probable VaD. A total of 75.3% of the 10 mg donepezil group and 80.8% of the 5 mg group completed the study compared with 83.4% of the placebo group. Both donepezil-treated groups showed improvements in cognitive function on the Alzheimer's Disease Assessment Scale-cognitive subscale compared with placebo, with a mean endpoint treatment difference, as measured by the change from baseline score, of approximately 2 points (donepezil 5 mg, -1.65 [p = 0.003]; 10 mg, -2.09 [p = 0.0002]). Greater improvements on the Clinician's Interview-Based Impression of Change-plus version were observed with both donepezil groups than with the placebo group (overall donepezil treatment vs placebo p = 0.008); 25% of the placebo group showed improvement compared with 39% (p = 0.004) of the 5 mg group and 32% (p = 0.047) of the 10 mg group. Withdrawal rates due to adverse events were low (placebo, 8.8%; donepezil 5 mg, 10.1%; 10 mg, 16.3%). CONCLUSIONS: Donepezil-treated patients demonstrated significant improvements in cognition and global function compared with placebo-treated patients, and donepezil was well tolerated.

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AdultAgedAged, 80 and overCholinesterase InhibitorsDementia, VascularDonepezilDouble-Blind MethodFemaleHeart DiseasesHumansHypercholesterolemiaHypertensionIndansMaleMiddle AgedNeuropsychological TestsNootropic AgentsPiperidinesRisk FactorsSmokingStrokeTreatment OutcomeClinical TrialComparative StudyJournal ArticleMulticenter StudyRandomized Controlled TrialResearch Support, Non-U.S. Gov't

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D Wilkinson, R Doody, R Helme, K Taubman, J Mintzer, A Kertesz, R D Pratt, Donepezil 308 Study Group. 2003-08-26. Donepezil in vascular dementia: a randomized, placebo-controlled study.. https://doi.org/10.1212/01.wnl.0000078943.50032.fc

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