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Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled trial
Mori E, Ikeda M, Kosaka K, Donepezil-DLB Study Investigators.. Annals of neurology, 2012-07-01
Topic: Risk, prevention and care in population studies
Objective Because cholinergic deficits are prominent in dementia with Lewy bodies (DLB), we investigated the effects of a cholinesterase inhibitor, donepezil, in such patients in a randomized, double-blind, placebo-controlled exploratory phase 2 trial. Methods One-hundred forty patients with DLB, recruited from 48 specialty centers in Japan, were randomly assigned to receive placebo or 3, 5, or 10 mg of donepezil hydrochloride daily for 12 weeks (n = 35, 35, 33, and 37, respectively). Effects on cognitive function were assessed using the Mini-Mental State Examination (MMSE) and several domain-specific neuropsychological tests. Changes in behavior were evaluated using the Neuropsychiatric Inventory, caregiver burden using the Zarit Caregiver Burden Interview, and global function using the Clinician's Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus). Safety measures included the Unified Parkinson's Disease Rating Scale part III. Results Donepezil at 5 and 10 mg/day was significantly superior to placebo on both the MMSE (5 mg: mean difference, 3.8; 95% confidence interval [CI], 2.3-5.3; p Interpretation Donepezil at 5 and 10mg/day produces significant cognitive, behavioral, and global improvements that last at least 12 weeks in DLB patients, reducing caregiver burden at the highest dose. Donepezil is safe and well tolerated.
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APA 7th
Mori, E., Ikeda, M., Kosaka, K., & Donepezil-DLB Study Investigators. (2012). Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled trial. Annals of neurology. https://doi.org/10.1002/ana.23557
Vancouver
Mori E, Ikeda M, Kosaka K, Donepezil-DLB Study Investigators. Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled trial. Annals of neurology. 2012. doi:10.1002/ana.23557. PMID: 22829268.
BibTeX
@article{mori2012-22829268,
author = {Mori, E. and Ikeda, M. and Kosaka, K. and {Donepezil-DLB Study Investigators}},
title = {{Donepezil for dementia with Lewy bodies: a randomized, placebo-controlled trial}},
journal = {Annals of neurology},
year = {2012},
doi = {10.1002/ana.23557},
pmid = {22829268},
url = {https://doi.org/10.1002/ana.23557}
}
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Key findings
- Results Donepezil at 5 and 10 mg/day was significantly superior to placebo on both the MMSE (5 mg: mean difference, 3.8; 95% confidence interval [CI], 2.3-5.3; p < 0.001; 10 mg: mean difference, 2.4; 95% CI, 0.9-3.9; p = 0.001) and CIBIC-plus (p < 0.001 for each); 3 mg/day was significantly superior to placebo on CIBIC-plus (p < 0.001), but not on the MMSE (p = 0.017).
Why it matters
In this 12-week randomized trial of 140 patients with dementia with Lewy bodies, donepezil at 5 and 10 mg/day improved cognition, behavior, and global function and reduced caregiver burden at the highest dose. The trial was exploratory and short-term, so it does not show a cure or long-term benefit.
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Study details
- Study designclinical trial
- Participants35
- 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 (Annals of neurology) |
| Journal's citation record | 3 / 4 | Annals of Neurology: journal h-index 437 (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 | 2012 — within 20 year(s) of the newest study here |
| Sample size | 1 / 4 | 35 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 274 times (OpenAlex, 2026-10-10) |
| Citations per year | 3 / 5 | 17.1 citations a year over 16 year(s) since 2012 |
| Impact for its field and year | 4 / 6 | Cited 14.6× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 3 / 6 | Cited by 13 other studies in this library |
| Still being cited | 2 / 4 | Cited 47 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 | 1 / 3 | Tohoku University: institution h-index 880 (OpenAlex) |
| Multi-centre collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 22829268) |
| Free to read | 2 / 2 | Free to read |
| 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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