CoChat
Sign Up
Cited by 363Dementia and Cognitive Impairment ResearchCholinesterase and Neurodegenerative DiseasesAlzheimer's disease research and treatments

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

Doody, Rachelle S.·2001·Archives of Neurology
DOI 10.1001/archneur.58.3.427
Open this paper in CoChat — free account

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.

Overview

Integrity signals

Registry

Crossref · 10.1001/archneur.58.3.427

Cites

14 of 14 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Verification

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Citations

Cites

Flagged first, then by citations

Show all 14 references

Cited by

Sorted by citations

Items 301–363 of 363

Related

See all

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)
DOI
10.1001/archneur.58.3.427
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

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review