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Cited by 71Dementia and Cognitive Impairment ResearchCholinesterase and Neurodegenerative DiseasesAlzheimer's disease research and treatments

Efficacy and safety of donepezil over 3 years: an open-label, multicentre study in patients with Alzheimer's disease

Burns, A., Gauthier, S., Perdomo, C.·2007·International Journal of Geriatric Psychiatry
DOI 10.1002/gps.1746
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Abstract

OBJECTIVE: This 132-week, open-label extension study assessed the long-term efficacy and safety of donepezil in 579 patients with mild to moderate Alzheimer's disease (AD) who had previously participated in a 24-week double-blind study of 5 or 10 mg/day donepezil vs placebo. METHOD: Patients enrolled in the present study had a 6-week single-blind placebo washout period followed by treatment with donepezil 5 mg/day for 6 weeks with an optional increase in dosage to 10 mg/day between weeks 6 and 32. RESULTS: After 6 weeks of open-label treatment with donepezil 5 mg/day, mean Alzheimer's Disease Assessment Scale -- cognitive subscale scores (ADAS-cog) improved by approximately two points, while after 12 weeks of open-label treatment (with a majority of patients receiving 10 mg/day), the mean ADAS-cog score was 1 point better than the score at the end of the placebo washout period. Scores then declined gradually over the remainder of the study. Mean changes in Clinical Dementia Rating-Sum of Boxes scores showed slight improvement over the first 12 weeks of open-label treatment and then slowly declined for the remainder of the study period. Donepezil was well tolerated over the entire 162-week study period. Overall, 85% of patients experienced at least one adverse event (AE). The most common included diarrhoea (12%), nausea (11%), infection (11%) and accidental injury (10%). Some patients discontinued the study due to AEs (15%). CONCLUSIONS: These results support the conclusion that donepezil is safe and effective for the long-term treatment of patients with mild to moderate AD.

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  • Longer term benefits of cholinesterase inhibitors, from 2 to 4 or more years, have been demonstrated in open-label extension and long-term prospective observational clinical cohort studies.

    “Longer term benefits, from 2 to 4 or more years have been demonstrated in open-label extension 69,[88][89][90] and long-term prospective observational clinical cohort studies.[91][92][93][94][95]”

    From The Alzheimer’s Disease Clinical Spectrum (2019) · cites this paper as [88]

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Authors
Burns, A., Gauthier, S., & Perdomo, C.
Affiliations
  • University of Manchester (GB)
  • McGill University (CA)
  • Eisai (United States) (US)
Corresponding author
Burns, A.
ORCID
Venue
International Journal of Geriatric Psychiatry
Publisher
Wiley
Published
2007-01-02
Volume
22
Issue
8
Pages
806-812
ISSN
  • 0885-6230 (ISSN-L)
  • 1099-1166
DOI
10.1002/gps.1746
OpenAlex
W2018309238
Cited by
71
References
24
Citations by year
2026: 1 · 2025: 5 · 2024: 1 · 2023: 1 · 2022: 6 · 2021: 3 · 2020: 1 · 2019: 4 · 2018: 1 · 2017: 3 · 2015: 5 · 2014: 3 · 2013: 5 · 2012: 4
FWCI
4.84
Type
journal article
Language
en
Open access
closed
Licence
onlinelibrary.wiley.com/termsAndConditions#vor (vor)
Locations
  • International Journal of Geriatric Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
Funders
Eisai
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
Keywords
donepezil, Alzheimer's disease, long-term efficacy, drug safety, cholinesterase inhibitors, open-label extension, ADAS-Cog, Clinical Dementia Rating, adverse events, dose escalation, mild to moderate dementia
MeSH terms
Donepezil, Aged, Aged, 80 and over, Alzheimer Disease, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Indans, Long-Term Care, Male, Middle Aged, Neuropsychological Tests, Piperidines, Single-Blind Method, Treatment Outcome, Nootropic Agents

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