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A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease
Feldman H, Gauthier S, Hecker J, Vellas B, Subbiah P, Whalen E, Donepezil MSAD Study Investigators Group.. Neurology, 2001-08-01
Topic: Amyloid, tau and blood-test diagnosis
Objective To investigate the efficacy and safety of donepezil in patients with moderate to severe AD (standardized Mini-Mental State Examination [sMMSE] scores of 5 to 17; Functional Assessment Staging score Methods Two-hundred ninety patients were randomized to treatment in this 24-week, double-blind, placebo-controlled trial. Patients received either donepezil 5 mg/day for the first 28 days and 10 mg/day thereafter as per the clinician's judgment (n = 144) or placebo (n = 146). The primary outcome measure was the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC+). Results Patients' mean age was 73.6 years (range 48 to 92 years). Baseline demographics were similar between the treatment groups. Least squares (LS) mean +/- SE sMMSE scores at baseline were 11.7 +/- 0.35 for the donepezil group and 12.0 +/- 0.34 for the placebo group. Patients receiving donepezil showed benefits on the CIBIC+, compared with placebo, at all visits up to week 24 (p Conclusion These data suggest that donepezil's benefits extend into more advanced stages of AD than those previously investigated, with very good tolerability.
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APA 7th
Feldman, H., Gauthier, S., Hecker, J., Vellas, B., Subbiah, P., Whalen, E., et al. (2001). A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease. Neurology. https://doi.org/10.1212/wnl.57.4.613
Vancouver
Feldman H, Gauthier S, Hecker J, Vellas B, Subbiah P, Whalen E, et al. A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease. Neurology. 2001. doi:10.1212/wnl.57.4.613. PMID: 11524468.
BibTeX
@article{feldman2001-11524468,
author = {Feldman, H. and Gauthier, S. and Hecker, J. and Vellas, B. and Subbiah, P. and Whalen, E. and {Donepezil MSAD Study Investigators Group}},
title = {{A 24-week, randomized, double-blind study of donepezil in moderate to severe Alzheimer's disease}},
journal = {Neurology},
year = {2001},
doi = {10.1212/wnl.57.4.613},
pmid = {11524468},
url = {https://doi.org/10.1212/wnl.57.4.613}
}
Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. The record names 7 authors; APA and Vancouver show the first six, BibTeX and the downloads carry all of them. Check the citation against the original before you use it.
Key findings
- Results Patients' mean age was 73.6 years (range 48 to 92 years).
- Patients receiving donepezil showed benefits on the CIBIC+, compared with placebo, at all visits up to week 24 (p Conclusion These data suggest that donepezil's benefits extend into more advanced stages of AD than those previously investigated, with very good tolerability.
Why it matters
In this 24-week randomized trial, donepezil produced benefits on a global measure of change compared with placebo in patients with moderate to severe Alzheimer's disease. This shows a symptomatic benefit in more advanced disease, not a cure or prevention.
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Study details
- Participants144
- Evidence strengthHigh
How this study scored 74/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for effect reported because the record does not state it. We have no data on senior author's track record, so that was left out: it earned 71 of the 96 points we could judge it on, which is 74 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 9 / 10 | Tier 2 — leading specialty journal (Neurology) |
| Journal's citation record | 4 / 4 | Neurology: journal h-index 525 (OpenAlex, 2026-10-29) |
| Study design | 11 / 12 | A randomised controlled trial (from PubMed type “Randomized Controlled Trial”) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 1 / 5 | 2001 — older than 20 years, still counted |
| Sample size | 2 / 4 | 144 participants |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 3 / 3 | Studied in people (participant count stated) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 6 / 7 | Cited 604 times (OpenAlex, 2026-10-10) |
| Citations per year | 4 / 5 | 22.4 citations a year over 27 year(s) since 2001 |
| Impact for its field and year | 5 / 6 | Cited 32.8× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 29 other studies in this library |
| Still being cited | 2 / 4 | Cited 16 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | 0 / 3 | University of British Columbia Hospital: institution h-index 253 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 11524468) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 71 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 71 of the 96 points we could judge it on is 74 out of 100. |
| Total | 74 / 100 | — |
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