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A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group
Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT.. Neurology, 1998-01-01
Topic: Amyloid, tau and blood-test diagnosis
The efficacy and safety of donepezil as a treatment for patients with mild to moderate Alzheimer's disease (AD) was investigated in a multicenter, double-blind study. Patients were randomly assigned to treatment with placebo (n = 162), 5 mg/d donepezil (n = 154), or 10 mg/d donepezil (n = 157) for 24 weeks followed by a 6-week, single-blind placebo washout. The primary efficacy measures were the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Clinician's Interview Based Assessment of Change-Plus (CIBIC plus), with the Mini-Mental State Examination (MMSE), Clinical Dementia Rating Scale-Sum of the Boxes (CDR-SB), and patient rated Quality of Life (QoL) used as secondary measures.
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APA 7th
Rogers, S. L., Farlow, M. R., Doody, R. S., Mohs, R., & Friedhoff, L. T. (1998). A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology. https://doi.org/10.1212/wnl.50.1.136
Vancouver
Rogers SL, Farlow MR, Doody RS, Mohs R, Friedhoff LT. A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group. Neurology. 1998. doi:10.1212/wnl.50.1.136. PMID: 9443470.
BibTeX
@article{rogers1998-9443470,
author = {Rogers, S. L. and Farlow, M. R. and Doody, R. S. and Mohs, R. and Friedhoff, L. T.},
title = {{A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group}},
journal = {Neurology},
year = {1998},
doi = {10.1212/wnl.50.1.136},
pmid = {9443470},
url = {https://doi.org/10.1212/wnl.50.1.136}
}
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Key findings
- Patients were randomly assigned to treatment with placebo (n = 162), 5 mg/d donepezil (n = 154), or 10 mg/d donepezil (n = 157) for 24 weeks followed by a 6-week, single-blind placebo washout.
- The primary efficacy measures were the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Clinician's Interview Based Assessment of Change-Plus (CIBIC plus), with the Mini-Mental State Examination (MMSE), Clinical Dementia Rating Scale-Sum of the Boxes (CDR-SB), and patient rated Quality of Life (QoL) used as secondary measures.
- Cognitive function, as measured by the ADAS-cog, was significantly improved in the 5- and 10-mg/d donepezil groups as compared with the placebo group at weeks 12, 18, and 24.
- Clinician's global ratings on the CIBIC plus also improved in both the 5- and 10-mg/d donepezil groups relative to placebo.
Why it matters
This 24-week double-blind, placebo-controlled trial investigated the efficacy and safety of donepezil in patients with mild to moderate Alzheimer's disease, with patients randomly assigned to placebo, 5 mg/d or 10 mg/d donepezil. The primary efficacy measures were the cognitive portion of the Alzheimer's Disease Assessment Scale and the Clinician's Interview Based Assessment of Change-Plus.
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Study details
- Participants162
- Evidence strengthLow
How this study scored 77/100
Published in a leading specialty journal, and it is a randomized 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 74 of the 96 points we could judge it on, which is 77 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 randomized 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 | 1998 — older than 20 years, still counted |
| Sample size | 2 / 4 | 162 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) |
| Randomized / blinded | 2 / 2 | Randomized and blinded or placebo-controlled (as stated in the record) |
| Times cited | 7 / 7 | Cited 1,621 times (OpenAlex, 2026-10-10) |
| Citations per year | 5 / 5 | 54.0 citations a year over 30 year(s) since 1998 |
| Impact for its field and year | 6 / 6 | Cited 101.3× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 4 / 6 | Cited by 78 other studies in this library |
| Still being cited | 3 / 4 | Cited 74 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) |
| Multicenter collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 9443470) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 74 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 74 of the 96 points we could judge it on is 77 out of 100. |
| Total | 77 / 100 | — |
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