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document
Efficacy and tolerability of donepezil in vascular dementia : positive results of a 24-week , multicenter , international , randomized , placebo-controlled clinical trial . 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 , -2.33 ; P < 0.001 ) . Significant improvements in patients ' global function were seen versus placebo at week 24 ( observed cases ) , on the Clinician 's Interview-Based Impression of Change-Plus version only for patients on donepezil 5 mg/d ( P=0.014 ) , and on the Sum of the Boxes of the Clinical Dementia Rating only for patients on 10 mg/d ( P=0.007 ) . Donepezil-treated patients showed significant benefits in activities of daily living over placebo on the Alzheimer 's Disease Functional Assessment and Change Scale ( mean change from baseline score effect size at week 24 : donepezil 5 mg/d , -1.31 , P=0.02 ; donepezil 10 mg/d , -1.31 , P=0.02 ) . Donepezil was well tolerated . Withdrawal rates due to adverse events were relatively low ( placebo , 11.1 % ; donepezil 5 mg/d , 11.1 % ; donepezil 10 mg/d , 21.8 % ; P=0.005 versus placebo ) . CONCLUSIONS These data demonstrate that donepezil is an effective and well-tolerated treatment for VaD and show it may have an important place in the management of this condition .
13899
Intervention_Pharmacological
donepezil
13900
Intervention_Control
placebo-controlled
13901
Intervention_Pharmacological
cholinesterase inhibitors
13902
Intervention_Pharmacological
donepezil
13903
Intervention_Pharmacological
donepezil
13904
Intervention_Pharmacological
donepezil
13905
Intervention_Control
placebo
13906
Intervention_Pharmacological
donepezil
13907
Intervention_Control
placebo
13908
Intervention_Pharmacological
donepezil
13909
Intervention_Pharmacological
donepezil
13910
Intervention_Pharmacological
donepezil
13911
Intervention_Control
placebo
13912
Outcome_Other
Efficacy
13913
Outcome_Other
tolerability
13914
Outcome_Other
efficacy
13915
Outcome_Other
safety
13916
Outcome_Mental
improvement in cognition
13917
Outcome_Mental
Alzheimer 's Disease Assessment Scale-cognitive subscale
13918
Outcome_Physical
patients ' global function
13919
Outcome_Mental
Clinician 's Interview-Based Impression of Change-Plus version
13920
Outcome_Physical
Sum of the Boxes of the Clinical Dementia Rating
13921
Outcome_Physical
activities of daily living
13922
Outcome_Mental
Alzheimer 's Disease Functional Assessment and Change Scale
13923
Outcome_Other
Withdrawal rates
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Outcome_Adverse-effects
adverse events
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Participant_Condition
vascular dementia
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Participant_Age
mean age , 73.9 years
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Participant_Sex
men