The DOI matches its Crossref record; 14 of the 14 references it cites were found in a registry or an index.
Open-Label, Multicenter, Phase 3 Extension Study of the Safety and Efficacy of Donepezil in Patients With Alzheimer Disease
Abstract
BACKGROUND: Donepezil hydrochloride is a selective acetylcholinesterase inhibitor approved for the symptomatic treatment of mild to moderately severe Alzheimer disease (AD). Controlled clinical trials of up to 24 weeks have demonstrated that donepezil treatment (5 and 10 mg/d) significantly improves cognition and global function. OBJECTIVE: To investigate the long-term benefits of donepezil treatment in patients with AD. DESIGN: Multicenter, open-label, 144-week extension of 2 US phase 3, double-blind, placebo-controlled clinical trials: a 15-week study (12 weeks of treatment followed by a 3-week placebo washout) and a 30-week study (24 weeks of treatment followed by a 6-week placebo washout). INTERVENTIONS: All patients (N = 763) initially received donepezil, 5 mg/d, for 6 weeks, after which an increase to 10 mg/d was encouraged. MEASURES: Primary efficacy measures were the Alzheimer's Disease Assessment Scale-cognitive subscale and the Clinical Dementia Rating-Sum of the Boxes. RESULTS: After the shorter 3-week placebo washout, donepezil-associated benefits remained above original baseline values for an additional 24 weeks of open-label treatment. Benefits on Alzheimer's Disease Assessment Scale-cognitive subscale scores for patients who received 10 mg/d in the double-blind study were evident compared with the other groups for 108 weeks of open-label treatment. In contrast, donepezil-associated benefits were lost after the 6-week placebo washout, and scores decreased below original baseline values for all patient groups. Although scores improved relative to the new open-label study baseline scores after drug use was restarted, patients remained below original baseline values. The most common adverse events were associated with the nervous and digestive systems and were generally mild and transient; 17% of patient discontinuations were associated with adverse events. CONCLUSIONS: Donepezil is an effective and safe drug for the long-term symptomatic treatment of mild to moderately severe AD for up to 144 weeks (2.8 years), and sustained treatment may confer some advantages.
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“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 [69]
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“Discontinuation of ChEI treatment is, on aggregate, harmful.”
From The Alzheimer’s Disease Clinical Spectrum (2019) · cites this paper as [69]
In the citing paper
“Patients taken off, or those inconsistently taking, anti-AD medications progress more rapidly than those who continue treatments, particularly ChEIs.”
From The Alzheimer’s Disease Clinical Spectrum (2019) · cites this paper as [69]
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Cites
Folstein, M. F., Folstein, S. E., & McHugh, P. R. (1975) · Journal of Psychiatric Research · doi:10.1016/0022-3956(75)90026-6 · Cited by 88,282
McKhann, G., Drachman, D., Folstein, M., Katzman, R., Price, D., & Stadlan, E. M. (1984) · Neurology · doi:10.1212/wnl.34.7.939 · Cited by 27,915
A New Clinical Scale for the Staging of Dementia
Hughes, C. P., Berg, L., Danziger, W., Coben, L. A., & Martin, R. L. (1982) · British Journal of Psychiatry · doi:10.1192/bjp.140.6.566 · Cited by 7,056
A new rating scale for Alzheimer's disease
(1984) · American Journal of Psychiatry · doi:10.1176/ajp.141.11.1356 · Cited by 4,175
A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease
Rogers, S. L., Farlow, M. R., Doody, R. S., Mohs, R., Friedhoff, L. T., & Donepezil Study Group* (1998) · Neurology · doi:10.1212/wnl.50.1.136 · Cited by 1,618
Rosler, M., Anand, R., Cicin-Sain, A., Gauthier, S., Agid, Y., Dal-Bianco, P., Stahelin, H. B., Hartman, R., Gharabawi, M., & Bayer, T. (1999) · BMJ · doi:10.1136/bmj.318.7184.633 · Cited by 943
Rogers, S. L. (1998) · Archives of Internal Medicine · doi:10.1001/archinte.158.9.1021 · Cited by 770
Rogers, S. L., & Friedhoff, L. T. (1996) · Dementia and Geriatric Cognitive Disorders · doi:10.1159/000106895 · Cited by 743
The Effects of Donepezil in Alzheimer’s Disease – Results from a Multinational Trial1
Burns, A. S., Rossor, M. N., Hecker, J. R., Gauthier, S. G., Petit, H., Möller, H. ‐., Rogers, S. L., & Friedhoff, L. T. (1999) · Dementia and Geriatric Cognitive Disorders · doi:10.1159/000017126 · Cited by 585
Rogers, S. L., Doody, R. S., Pratt, R. D., & Ieni, J. R. (2000) · European Neuropsychopharmacology · doi:10.1016/s0924-977x(00)00067-5 · Cited by 268
Metrifonate treatment of the cognitive deficits of Alzheimer's disease
Cummings, J. L., Cyrus, P., Bieber, F., Mas, J., Orazem, J. P., Gulanski, B., & The Metrifonate Study Group* (1998) · Neurology · doi:10.1212/wnl.50.5.1214 · Cited by 173
E2020 — The Pharmacology of a Piperidine Cholinesterase Inhibitor
Rogers, S. L., Yamanishi, Y., & Yamatsu, K. (1991) · Birkhäuser Boston eBooks · doi:10.1007/978-1-4899-6738-1_33 · Cited by 88
Thal, L. J., Schwartz, G. E., Sano, M. C., Weiner, M., Knopman, D. S., Harrell, L. E., Bodenheimer, S. L., Rossor, M. N., Philpot, M. P., Schor, J., et al. (1996) · Neurology · doi:10.1212/wnl.47.6.1389 · Cited by 80
Yamanishi, Y., Ogura, H., Kosasa, T., Araki, S., Sawa, Y., & Yamatsu, K. (1990) · Advances in behavioral biology · doi:10.1007/978-1-4684-5847-3_83 · Cited by 38
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Cholinesterase inhibitors for Alzheimer's disease
Birks, J. S. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd005593 · Cited by 1,906
Cummings, J. L. (2004) · New England Journal of Medicine · doi:10.1056/nejmra040223 · Cited by 1,152
Antibodies against β-Amyloid Slow Cognitive Decline in Alzheimer's Disease
Höck, C., Konietzko, U., Streffer, J. R., Tracy, J., Signorell, A., Müller-Tillmanns, B., Lemke, U., Henke, K., Moritz, E., Garcia, E., et al. (2003) · Neuron · doi:10.1016/s0896-6273(03)00294-0 · Cited by 786
A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD
Winblad, B. G., Engedal, K., Soininen, H. S., Verhey, F. R. J., Waldemar, G., Wimo, A. B., Wetterholm, A.-L., Zhang, R., Haglund, A., Subbiah, P., et al. (2001) · Neurology · doi:10.1212/wnl.57.3.489 · Cited by 721
Auld, D. S., Kornecook, T. J., Bastianetto, S., & Quirion, R. (2002) · Progress in Neurobiology · doi:10.1016/s0301-0082(02)00079-5 · Cited by 678
Metadata
- Authors
- Doody, R. S.
- Affiliations
- Baylor College of Medicine (US)
- Corresponding author
- Doody, Rachelle S.
- Venue
- Archives of Neurology
- Publisher
- American Medical Association (AMA)
- Published
- 2001-03-01
- Volume
- 58
- Issue
- 3
- Pages
- 427
- ISSN
- 0003-9942 (ISSN-L)
- OpenAlex
- W2064649894
- Cited by
- 362
- References
- 14
- Citations by year
- 2026: 3 · 2025: 5 · 2024: 2 · 2023: 6 · 2022: 2 · 2021: 5 · 2020: 4 · 2019: 6 · 2018: 11 · 2017: 5 · 2016: 8 · 2015: 14 · 2014: 7 · 2013: 13 · 2012: 11
- FWCI
- 21.77
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Neurology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Pharmacology (medical) › Cholinesterase and Neurodegenerative Diseases
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
- Keywords
- donepezil, Alzheimer's disease, acetylcholinesterase inhibitors, long-term treatment, cognitive function, Clinical Dementia Rating, adverse events, drug discontinuation, symptomatic treatment
- MeSH terms
- Donepezil, Aged, Alzheimer Disease, Cholinesterase Inhibitors, Double-Blind Method, Female, Humans, Indans, Male, Middle Aged, Neuropsychological Tests, Piperidines, Treatment Outcome
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