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Donepezil preserves cognition and global function in patients with severe Alzheimer disease
Black SE, Doody R, Li H, McRae T, Jambor KM, Xu Y, Sun Y, Perdomo CA et al.. Neurology, 2007-07-01
Topic: Amyloid, tau and blood-test diagnosis
Objective To evaluate the efficacy and safety of donepezil for severe Alzheimer disease (AD). Methods Patients with severe AD (Mini-Mental State Examination [MMSE] scores 1 to 12 and Functional Assessment Staging [FAST] scores > or =6) were enrolled in this multinational, double-blind, placebo-controlled trial at 98 sites. Patients were randomized to donepezil 10 mg daily or placebo for 24 weeks. Primary endpoints were the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus). Secondary endpoints included the MMSE, the Alzheimer Disease Cooperative Study-Activities of Daily Living-severe version (ADCS-ADL-sev), the Neuropsychiatric Inventory (NPI), the Caregiver Burden Questionnaire (CBQ), and the Resource Utilization for Severe Alzheimer Disease Patients (RUSP). Efficacy analyses were performed in the intent-to-treat (ITT) population using last post-baseline observation carried forward (LOCF). Safety assessments were performed for patients receiving > or =1 dose of donepezil or placebo. Results Patients were randomized to donepezil (n = 176) or placebo (n = 167). Donepezil was superior to placebo on SIB score change from baseline to endpoint (least squares mean difference 5.32; p = 0.0001). CIBIC-Plus and MMSE scores favored donepezil at endpoint (p = 0.0473 and p = 0.0267). Donepezil was not significantly different from placebo on the ADCS-ADL-sev, NPI, CBQ, or RUSP. Adverse events reported were consistent with the known cholinergic effects of donepezil and with the safety profile in patients with mild to moderate AD. Conclusion Patients with severe AD demonstrated greater efficacy compared to placebo on measures of cognition and global function.
Key findings
- Results Patients were randomized to donepezil (n = 176) or placebo (n = 167).
- Donepezil was not significantly different from placebo on the ADCS-ADL-sev, NPI, CBQ, or RUSP.
- Conclusion Patients with severe AD demonstrated greater efficacy compared to placebo on measures of cognition and global function.
Why it matters
In this 24-week trial, donepezil was superior to placebo on measures of cognition and global function in patients with severe Alzheimer's disease. Donepezil was not significantly different from placebo on measures of daily living, neuropsychiatric symptoms, caregiver burden, or resource utilization.
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Study details
- Participants176
- Evidence strengthHigh
How this study scored 72/100
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 69 of the 96 points we could judge it on, which is 72 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 | 2007 — within 20 year(s) of the newest study here |
| Sample size | 2 / 4 | 176 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 | 5 / 7 | Cited 256 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 12.2 citations a year over 21 year(s) since 2007 |
| Impact for its field and year | 4 / 6 | Cited 15.7× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 2 / 6 | Cited by 9 other studies in this library |
| Still being cited | 2 / 4 | Cited 17 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 | University of Toronto: institution h-index 1,923 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | OpenAlex lists 5 institution(s) in 2 countries |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 17664405) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 69 / 96 | Scored on 19 of 20 parts. We have no data for the rest, so they are left out: 69 of the 96 points we could judge it on is 72 out of 100. |
| Total | 72 / 100 | — |
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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.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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's author list ends in “et al.”, so not every author is named. Check the citation against the original before you use it.
APA 7th
Black, S. E., Doody, R., Li, H., McRae, T., Jambor, K. M., Xu, Y., et al. (2007). Donepezil preserves cognition and global function in patients with severe Alzheimer disease. Neurology. https://doi.org/10.1212/01.wnl.0000266627.96040.5a
Vancouver
Black SE, Doody R, Li H, McRae T, Jambor KM, Xu Y, et al. Donepezil preserves cognition and global function in patients with severe Alzheimer disease. Neurology. 2007. doi:10.1212/01.wnl.0000266627.96040.5a. PMID: 17664405.
BibTeX
@article{black2007-17664405,
author = {Black, S. E. and Doody, R. and Li, H. and McRae, T. and Jambor, K. M. and Xu, Y. and Sun, Y. and Perdomo, C. A. and others},
title = {{Donepezil preserves cognition and global function in patients with severe Alzheimer disease}},
journal = {Neurology},
year = {2007},
doi = {10.1212/01.wnl.0000266627.96040.5a},
pmid = {17664405},
url = {https://doi.org/10.1212/01.wnl.0000266627.96040.5a}
}
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