Efficacy and Tolerability of Donepezil in Vascular Dementia

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Abstract
Background and Purpose— Clinical observations suggest that patients with vascular dementia (VaD) may benefit from treatment with cholinesterase inhibitors. This study evaluated the efficacy and safety of donepezil for relieving symptoms of dementia in VaD. Methods— Patients (n=603; mean age, 73.9 years; 55.2% men) with probable (70.5%) or possible (29.5%) VaD, according to criteria of the National Institute of Neurological Disorders and Stroke (NINDS) and the Association Internationale pour la Recherche et l’Enseignement en Neurosciences (AIREN), were randomized to 24 weeks of treatment with donepezil 5 mg/d (n=198), donepezil 10 mg/d (5 mg/d for first 28 days; n=206), or placebo (n=199). Analyses were based on the intent-to-treat population. Results— At week 24, both donepezil groups showed significant improvement in cognition versus placebo on the Alzheimer’s Disease Assessment Scale–cognitive subscale (mean change from baseline score effect size: donepezil 5 mg/d, −1.90; P=0.001; donepezil 10 mg/d, −2....