A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD

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Winblad, BKarolinska Institutet (author)

A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD

Article/chapterEnglish2001

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2001-08-14
Ovid Technologies (Wolters Kluwer Health),2001

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LIBRIS-ID:oai:prod.swepub.kib.ki.se:1945219
http://kipublications.ki.se/Default.aspx?queryparsed=id:1945219URI
https://doi.org/10.1212/wnl.57.3.489DOI

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Language:English
Summary in:English

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Subject category:art swepub-publicationtype

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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.

Added entries (persons, corporate bodies, meetings, titles ...)

Engedal, K (author)
Soininen, H (author)
Verhey, F (author)
Waldemar, G (author)
Wimo, AKarolinska Institutet (author)
Wetterholm, AL (author)
Zhang, R (author)
Haglund, A (author)
Subbiah, P (author)
Karolinska Institutet (creator_code:org_t)

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In:Neurology: Ovid Technologies (Wolters Kluwer Health)57:3, s. 489-4950028-38781526-632X

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By the author/editor: Winblad, B; Engedal, K; Soininen, H; Verhey, F; Waldemar, G; Wimo, A; show more...; Wetterholm, AL; Zhang, R; Haglund, A; Subbiah, P; show less...

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