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A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients
Mohs RC, Doody RS, Morris JC, Ieni JR, Rogers SL, Perdomo CA, Pratt RD, "312" Study Group.. Neurology, 2001-08-01
Topic: Risk, prevention and care in population studies
Objective To examine the effects of donepezil compared with placebo on the preservation of function in patients with AD over a 1-year period. Methods This was a prospective, 54-week, double-blind, placebo-controlled, survival to endpoint study. Patients were required to have at entry: a diagnosis of probable AD (National Institute of Neurological and Communicative Disorders and Stroke criteria); Mini-Mental State Examination score of 12 to 20; Clinical Dementia Rating of 1 or 2; modified Hachinski ischemia score Results Donepezil extended the median time to clinically evident functional decline by 5 months versus placebo. The probability of patients treated with donepezil remaining in the study with no clinically evident functional loss was 51% at 48 weeks, compared with 35% for placebo. The Kaplan-Meier survival curves for the two treatment groups were different (p = 0.002, log-rank test). Conclusions Patients with AD continue to show detectable disease progression over time, but treatment with donepezil for 1 year was associated with a 38% reduction in the risk of functional decline compared with placebo.
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APA 7th
Mohs, R. C., Doody, R. S., Morris, J. C., Ieni, JR., Rogers, S. L., Perdomo, C. A., et al. (2001). A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients. Neurology. https://doi.org/10.1212/wnl.57.3.481
Vancouver
Mohs RC, Doody RS, Morris JC, Ieni JR, Rogers SL, Perdomo CA, et al. A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients. Neurology. 2001. doi:10.1212/wnl.57.3.481. PMID: 11502917.
BibTeX
@article{mohs2001-11502917,
author = {Mohs, R. C. and Doody, R. S. and Morris, J. C. and Ieni, JR. and Rogers, S. L. and Perdomo, C. A. and Pratt, R. D. and {"312" Study Group}},
title = {{A 1-year, placebo-controlled preservation of function survival study of donepezil in AD patients}},
journal = {Neurology},
year = {2001},
doi = {10.1212/wnl.57.3.481},
pmid = {11502917},
url = {https://doi.org/10.1212/wnl.57.3.481}
}
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
- Objective To examine the effects of donepezil compared with placebo on the preservation of function in patients with AD over a 1-year period.
- Patients were required to have at entry: a diagnosis of probable AD (National Institute of Neurological and Communicative Disorders and Stroke criteria); Mini-Mental State Examination score of 12 to 20; Clinical Dementia Rating of 1 or 2; modified Hachinski ischemia score < or =4; and capability of performing 8 of 10 instrumental activities of daily living and 5 of 6 basic activities of daily living.
- The probability of patients treated with donepezil remaining in the study with no clinically evident functional loss was 51% at 48 weeks, compared with 35% for placebo.
- Conclusions Patients with AD continue to show detectable disease progression over time, but treatment with donepezil for 1 year was associated with a 38% reduction in the risk of functional decline compared with placebo.
Why it matters
In this 1-year trial, donepezil extended the time to functional decline by about 5 months compared with placebo and reduced the risk of functional decline by 38%. It does not cure or prevent Alzheimer's disease, but it may help preserve everyday function for a period in patients with mild to moderate disease.
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Study details
- Evidence strengthLow
Limitations
The abstract excerpt available does not give the sample size or specify how ‘clinically evident functional decline’ was defined, both of which would matter for judging how meaningful a 5-month delay is in practice.
How this study scored 67/100
Published in a leading specialty journal, and it is a randomised controlled trial. Scored zero for sample size and 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 64 of the 96 points we could judge it on, which is 67 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 | 1 / 5 | Rated “low” 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 | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| 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 (pubmed indexes it as a clinical or observational study) |
| Randomised / blinded | 2 / 2 | Randomised and blinded or placebo-controlled (as stated in the record) |
| Times cited | 6 / 7 | Cited 507 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 18.8 citations a year over 27 year(s) since 2001 |
| Impact for its field and year | 5 / 6 | Cited 31.4× 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 15 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 | Baylor College of Medicine: institution h-index 1,607 (OpenAlex) |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 11502917) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 64 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 64 of the 96 points we could judge it on is 67 out of 100. |
| Total | 67 / 100 | — |
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