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A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD
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- Winblad, B (author)
- Karolinska Institutet
- Engedal, K (author)
- Soininen, H (author)
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- Verhey, F (author)
- Waldemar, G (author)
- Wetterholm, AL (author)
- Zhang, R (author)
- Haglund, A (author)
- Subbiah, P (author)
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- (creator_code:org_t)
- 2001-08-14
- 2001
- English.
- In: Neurology. - : Ovid Technologies (Wolters Kluwer Health). - 0028-3878 .- 1526-632X. ; 57:3, s. 489-495
- Journal article (peer-reviewed)
Abstract
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- Objective: To evaluate the long-term clinical efficacy and safety of donepezil versus placebo over 1 year in patients with mild to moderate AD.Methods: Patients (n = 286; mean age, 72.5 years) with possible or probable AD from five Northern European countries were randomized to receive either donepezil (n = 142; 5 mg/day for 28 days, followed by 10 mg/day) or placebo (n = 144) for 1 year.Results: The study was completed by 66.9% of the donepezil- and 67.4% of the placebo-treated patients. The benefit of donepezil over placebo was demonstrated by the Gottfries-Bråne-Steen (a global assessment for rating dementia symptoms) total score at weeks 24, 36, and 52 (p < 0.05) and at the study end point (week 52, last observation carried forward; p = 0.054). Advantages of donepezil over placebo were also observed in cognition and activities of daily living (ADL) assessed by the Mini-Mental State Examination at weeks 24, 36, and 52, and the end point (p < 0.02) and by the Progressive Deterioration Scale at week 52 and the end point (p < 0.05). Adverse events (AE) were recorded for 81.7% of donepezil- and 75.7% of placebo-treated patients, with 7% of donepezil- and 6.3% of placebo-treated patients discontinuing because of AE. Treatment response to donepezil was not predicted by APOE genotype or sex in this population.Conclusion: As the first 1-year, multinational, double-blinded, placebo-controlled study of a cholinesterase inhibitor in AD, these data support donepezil as a well tolerated and effective long-term treatment for patients with AD, with benefits over placebo on global assessment, cognition, and ADL.
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- Winblad, B
- Engedal, K
- Soininen, H
- Verhey, F
- Waldemar, G
- Wimo, A
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- Wetterholm, AL
- Zhang, R
- Haglund, A
- Subbiah, P
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