Cited by 161Dementia and Cognitive Impairment ResearchNeurological Disease Mechanisms and TreatmentsAlzheimer's disease research and treatments

Randomized, Placebo-Controlled, Clinical Trial of Donepezil in Vascular Dementia: Differential Effects by Hippocampal Size

Open access
Román, Gustavo C., Salloway, Stephen, Black, Sandra E., Royall, Donald R., DeCarli, Charles, Weiner, Michael W., Moline, Margaret, Kumar, Dinesh +2 more·2010·Stroke

Abstract

Background and Purpose— We sought to assess the efficacy and safety of donepezil in patients with vascular dementia (VaD) fulfilling National Institute of Neurological Disorders and Stroke–Association Internationale pour la Recherche et l’Enseignement en Neurosciences criteria. Methods— This international, multicenter, 24-week trial was conducted from March 2003 to August 2005. Patients (N=974; mean age, 73.0 years) with probable or possible VaD were randomized 2:1 to receive donepezil 5 mg/d or placebo. Coprimary outcome measures were scores on the Vascular-Alzheimer Disease Assessment Scale–Cognitive Subscale and Clinician’s Interview–Based Impression of Change, plus carer interview. Analyses were performed for the intent-to-treat population with the last-observation-carried-forward method. Results— Compared with placebo, donepezil-treated patients showed significant improvement from baseline to end point on the Vascular-Alzheimer Disease Assessment Scale–Cognitive Subscale (least-squares mean difference, −1.156; 95% CI, −1.98 to −0.33; P <0.01) but not on the Clinician’s Interview–Based Impression of Change, plus carer interview. Patients with hippocampal atrophy who were treated with donepezil demonstrated stable cognition versus a decline in the placebo-treated group; in those without atrophy, cognition improved with donepezil versus relative stability with placebo. Results on secondary efficacy measures were inconsistent. The incidence of adverse events was similar across groups. Eleven deaths occurred in the donepezil group (1.7%), similar to rates previously reported for donepezil trials in VaD, whereas no deaths occurred in the placebo group. Conclusions— Patients treated with donepezil 5 mg/d demonstrated significant improvement in cognitive, but not global, function. Donepezil was relatively well tolerated; adverse events were consistent with current labeling. Mortality in the placebo group was unexpectedly low. The differential treatment response of VaD patients by hippocampal size suggests that hippocampal imaging warrants further investigation for understanding VaD.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

Integrity signals

Registry

Crossref · 10.1161/strokeaha.109.570077

Cites

29 of 29 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

A few free checks a day · papers already verified open instantly · results are public

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?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

Cites

Flagged first, then by citations

1 of the 30 references couldn’t be matched to a known paper.

Cited by

Sorted by citations

Authors
Román, G. C., Salloway, S., Black, S. E., Royall, D. R., DeCarli, C., Weiner, M. W., Moline, M., Kumar, D., Schindler, R., & Posner, H.
Affiliations
  • From the Department of Neurology (G.C.R.), School of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Tex; Department of Neurology and the Memory and Aging Program (S.S.), Brown Alpert Medical School, Butler Hospital, Providence, RI; Department of Neurology (S.E.B.), University of Toronto, Sunnybrook Health Sciences Centre, Toronto, Canada; Departments of Psychiatry, Medicine, Pharmacology, and Family and Community Medicine, Division of Aging and Geriatric Psychiatry ...
  • San Francisco VA Medical Center (US)
Venue
Stroke
Published
2010-06
Volume
41
Issue
6
Pages
1213-1221
ISSN
  • 0039-2499 (ISSN-L)
  • 1524-4628
OpenAlex
W2155669855
Cited by
161
References
30
Citations by year
2026: 6 · 2025: 7 · 2024: 12 · 2023: 4 · 2022: 9 · 2021: 10 · 2020: 11 · 2019: 6 · 2018: 9 · 2017: 11 · 2016: 15 · 2015: 11 · 2014: 11 · 2013: 12 · 2012: 9
FWCI
8.07
Type
journal article
Language
en
Open access
Locations
  • Stroke (publishedVersion)
  • PubMed (publishedVersion)
  • Europe PMC (PubMed Central) (acceptedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • Pfizer
  • Eisai
  • National Institute on Aging (P30AG010129)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Life Sciences › Neuroscience › Neurology › Neurological Disease Mechanisms and Treatments
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
Keywords
donepezil, vascular dementia, cholinesterase inhibitors, cognitive function, hippocampal atrophy, mortality, adverse events, treatment response
MeSH terms
Donepezil, Adult, Aged, Aged, 80 and over, Cognition, Double-Blind Method, Female, Hippocampus, Humans, Indans, Male, Middle Aged, Organ Size, Piperidines, Radiography, Dementia, Vascular, Nootropic Agents

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