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Donepezil therapy in clinical practice: a randomized crossover study
Greenberg SM, Tennis MK, Brown LB, Gomez-Isla T, Hayden DL, Schoenfeld DA, Walsh KL, Corwin C et al.. Archives of neurology, 2000-01-01
Topic: Risk, prevention and care in population studies
Objective To determine the efficacy of donepezil hydrochloride for the treatment of Alzheimer disease in patients drawn from clinical practice. Design Two-center, randomized, placebo-controlled, double-masked crossover study. Setting Memory disorders units at Massachusetts General and Brigham and Women's hospitals, Boston. Patients Sixty individuals (30 men and 30 women; mean +/- SD age, 75.0+/-9.5 years) with probable Alzheimer disease and scores of 20 or less on the information-memory-concentration subscale of the Blessed Dementia Scale. Interventions Placebo wash-in, followed in randomized sequence by (1) donepezil hydrochloride therapy, 5 mg/d, for 6 weeks, followed by placebo washout for 6 weeks and (2) placebo treatment for 6 weeks. Primary outcome measure Change in Alzheimer's Disease Assessment Scale cognitive subscale scores from the beginning to the end of the two 6-week treatment periods. Results Among patients completing treatment and testing for both periods (n = 48), subscale scores improved (mean +/- SEM) 2.17+/-0.98 points (95% confidence interval, 0.20-4.10 points) during donepezil therapy relative to placebo therapy (P = .04). Scores returned toward baseline within 3 weeks of drug washout. There was no associated change in caregiver-rated global impression (donepezil vs placebo: proportion improved, 0.24 vs 0.22; proportion worsened, 0.27 vs 0.35; P = .34) or on specific tests of explicit memory or verbal fluency. Contrary to studies with tacrine, the presence of the apolipoprotein E epsilon4 allele did not predict donepezil treatment failure. Most common adverse events related to donepezil therapy were nausea (5 patients), diarrhea (3 patients), and agitation (3 patients). Serious events possibly related to drug use were seizure, pancreatitis, and syncope (1 patient each). Conclusion This independent confirmation of data from phase 3 trials suggests that donepezil therapy modestly improves cognition in patients with Alzheimer disease who are encountered in clinical practice.
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APA 7th
Greenberg, S. M., Tennis, M. K., Brown, L. B., Gomez-Isla, T., Hayden, D. L., Schoenfeld, D. A., et al. (2000). Donepezil therapy in clinical practice: a randomized crossover study. Archives of neurology. https://doi.org/10.1001/archneur.57.1.94
Vancouver
Greenberg SM, Tennis MK, Brown LB, Gomez-Isla T, Hayden DL, Schoenfeld DA, et al. Donepezil therapy in clinical practice: a randomized crossover study. Archives of neurology. 2000. doi:10.1001/archneur.57.1.94. PMID: 10634454.
BibTeX
@article{greenberg2000-10634454,
author = {Greenberg, S. M. and Tennis, M. K. and Brown, L. B. and Gomez-Isla, T. and Hayden, D. L. and Schoenfeld, D. A. and Walsh, K. L. and Corwin, C. and others},
title = {{Donepezil therapy in clinical practice: a randomized crossover study}},
journal = {Archives of neurology},
year = {2000},
doi = {10.1001/archneur.57.1.94},
pmid = {10634454},
url = {https://doi.org/10.1001/archneur.57.1.94}
}
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Key findings
- Results Among patients completing treatment and testing for both periods (n = 48), subscale scores improved (mean +/- SEM) 2.17+/-0.98 points (95% confidence interval, 0.20-4.10 points) during donepezil therapy relative to placebo therapy (P = .04).
- Conclusion This independent confirmation of data from phase 3 trials suggests that donepezil therapy modestly improves cognition in patients with Alzheimer disease who are encountered in clinical practice.
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Study details
- Study designclinical trial
- Participants48
- Evidence strengthHigh
How this study scored 72/100
Published in a peer-reviewed 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 journal's citation record, times cited, citations per year, impact for its field and year, cited by studies here, still being cited, senior author's track record and institution's track record, so those were left out: it earned 44 of the 61 points we could judge it on, which is 72 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (Archives of neurology) |
| Journal's citation record | — / 4 | No journal record from OpenAlex — left out of this score |
| Study design | 11 / 12 | A randomized 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 | 2000 — older than 20 years, still counted |
| Sample size | 1 / 4 | 48 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 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | — / 6 | Not yet checked against this library's citation graph — left out of this score |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multicenter collaboration | 2 / 3 | PubMed indexes it as a multicentre study |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 10634454) |
| Free to read | 0 / 2 | Behind a paywall — scores zero |
| Points | 44 / 61 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 44 of the 61 points we could judge it on is 72 out of 100. |
| Total | 72 / 100 | — |
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