Home › Research › Treatments
Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial
Salloway S, Ferris S, Kluger A, Goldman R, Griesing T, Kumar D, Richardson S, Donepezil 401 Study Group.. Neurology, 2004-08-01
Topic: Risk, prevention and care in population studies
Objective To evaluate the efficacy and safety of the acetylcholinesterase inhibitor donepezil in a placebo-controlled trial in patients with mild cognitive impairment (MCI). Methods A total of 270 patients with MCI were enrolled in a 24-week, multicenter, randomized, double-blind, placebo-controlled study. Patients were randomized to receive donepezil (n = 133; 5 mg/day for 42 days, followed by forced dose escalation to 10 mg/day) or placebo (n = 137). Primary efficacy measures were the New York University (NYU) Paragraph Delayed Recall test and the Alzheimer disease (AD) Cooperative Study Clinician's Global Impression of Change for MCI (ADCS CGIC-MCI). Secondary efficacy measures included the modified AD Assessment Scale-cognitive subscale (ADAS-cog), the Patient Global Assessment (PGA), and additional neuropsychologic measures. Efficacy analyses were performed on intent-to-treat (ITT) and fully evaluable (FE) populations. Results Primary efficacy measures of the NYU Paragraph Recall test and the ADCS CGIC-MCI did not show significant treatment effects in the ITT population. Some secondary measures showed effects favoring donepezil. More donepezil-treated patients showed improvements in ADAS-cog total scores, in tests of attention and psychomotor speed, and in PGA scores. More donepezil-treated than placebo-treated patients experienced adverse events, most of which were mild to moderate and transient. Conclusion Although significant treatment effects were not seen in the primary efficacy measures, outcomes on secondary measures suggest promising directions for further evaluation of donepezil treatment in patients with MCI.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
APA 7th
Salloway, S., Ferris, S., Kluger, A., Goldman, R., Griesing, T., Kumar, D., et al. (2004). Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial. Neurology. https://doi.org/10.1212/01.wnl.0000134664.80320.92
Vancouver
Salloway S, Ferris S, Kluger A, Goldman R, Griesing T, Kumar D, et al. Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial. Neurology. 2004. doi:10.1212/01.wnl.0000134664.80320.92. PMID: 15326237.
BibTeX
@article{salloway2004-15326237,
author = {Salloway, S. and Ferris, S. and Kluger, A. and Goldman, R. and Griesing, T. and Kumar, D. and Richardson, S. and {Donepezil 401 Study Group}},
title = {{Efficacy of donepezil in mild cognitive impairment: a randomized placebo-controlled trial}},
journal = {Neurology},
year = {2004},
doi = {10.1212/01.wnl.0000134664.80320.92},
pmid = {15326237},
url = {https://doi.org/10.1212/01.wnl.0000134664.80320.92}
}
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 8 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 Primary efficacy measures of the NYU Paragraph Recall test and the ADCS CGIC-MCI did not show significant treatment effects in the ITT population.
- Conclusion Although significant treatment effects were not seen in the primary efficacy measures, outcomes on secondary measures suggest promising directions for further evaluation of donepezil treatment in patients with MCI.
Why it matters
In this 24-week trial of 270 patients with mild cognitive impairment, donepezil did not show significant treatment effects on the primary efficacy measures of the NYU Paragraph Delayed Recall test and the ADCS CGIC-MCI. Some secondary measures favored donepezil, and more donepezil-treated patients experienced adverse events, most of which were mild.
New to this subject? Start with our plain-English guide: Treatments →
Study details
- Participants133
- 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 | 2004 — older than 20 years, still counted |
| Sample size | 2 / 4 | 133 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 301 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 12.5 citations a year over 24 year(s) since 2004 |
| Impact for its field and year | 4 / 6 | Cited 16.9× 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 24 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 | 2 / 3 | New York University: institution h-index 1,612 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 4 institution(s) in 1 country |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 15326237) |
| 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 | — |
What each of these 20 components measures, and what this score is not →
Read the original
May need a subscription Unpaywall, Europe PMC and OpenAlex found no free copy of the full text (checked 10 Oct 2026), so the publisher may charge for it. The PubMed abstract is free.
Studies this one cites
Referenced by this study and also in the alzhub library, so you can read them here. Showing 12 of 13.
Later studies that cite this one
29 studies in the alzhub library list this one in their references. Showing the 8 highest-scoring.
Related studies in Treatments
Also tagged “double-blind”
783 studies in the library carry the topic tag “double-blind”; these are this study's neighbours in a fixed, alphabetical-by-hash tour of them, not the closest in content. All 783 tagged studies.