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67/100

✓ Peer-reviewed alzhub usefulness score 67 out of 100. Treatments

Topic: Drug trials: efficacy and safety

Plain-language summary

Background Clinical trials have shown the benefits of cholinesterase inhibitors for the treatment of mild-to-moderate Alzheimer's disease. It is not known whether treatment benefits continue after the progression to moderate-to-severe disease. Methods We assigned 295 community-dwelling patients who had been treated with donepezil for at least 3 months and who had moderate or severe Alzheimer's disease (a score of 5 to 13 on the Standardized Mini-Mental State Examination [SMMSE, on which scores range from 0 to 30, with higher scores indicating better cognitive function]) to continue donepezil, discontinue donepezil, discontinue donepezil and start memantine, or continue donepezil and start memantine. Patients received the study treatment for 52 weeks. The coprimary outcomes were scores on the SMMSE and on the Bristol Activities of Daily Living Scale (BADLS, on which scores range from 0 to 60, with higher scores indicating greater impairment). The minimum clinically important differences were 1.4 points on the SMMSE and 3.5 points on the BADLS. Results Patients assigned to continue donepezil, as compared with those assigned to discontinue donepezil, had a score on the SMMSE that was higher by an average of 1.9 points (95% confidence interval [CI], 1.3 to 2.5) and a score on the BADLS that was lower (indicating less impairment) by 3.0 points (95% CI, 1.8 to 4.3) (P<0.001 for both comparisons). Patients assigned to receive memantine, as compared with those assigned to receive memantine placebo, had a score on the SMMSE that was an average of 1.2 points higher (95% CI, 0.6 to 1.8; P<0.001) and a score on the BADLS that was 1.5 points lower (95% CI, 0.3 to 2.8; P=0.02). The efficacy of donepezil and of memantine did not differ significantly in the presence or absence of the other. There were no significant benefits of the combination of donepezil and memantine over donepezil alone. Conclusions In patients with moderate or severe Alzheimer's disease, continued treatment with donepezil was associated with cognitive benefits that exceeded the minimum clinically important difference and with significant functional benefits over the course of 12 months. (Funded by the U.K. Medical Research Council and the U.K. Alzheimer's Society; Current Controlled Trials number, ISRCTN49545035.).

Cite this study APA, Vancouver, BibTeX · download .bib or .ris

APA 7th

Howard, R., McShane, R., Lindesay, J., Ritchie, C., Baldwin, A., Barber, R., et al. (2012). Donepezil and memantine for moderate-to-severe Alzheimer's disease. The New England journal of medicine. https://doi.org/10.1056/nejmoa1106668

Vancouver

Howard R, McShane R, Lindesay J, Ritchie C, Baldwin A, Barber R, et al. Donepezil and memantine for moderate-to-severe Alzheimer's disease. The New England journal of medicine. 2012. doi:10.1056/nejmoa1106668. PMID: 22397651.

BibTeX

@article{howard2012-22397651,
  author  = {Howard, R. and McShane, R. and Lindesay, J. and Ritchie, C. and Baldwin, A. and Barber, R. and Burns, A. and Dening, T. and others},
  title   = {{Donepezil and memantine for moderate-to-severe Alzheimer's disease}},
  journal = {The New England journal of medicine},
  year    = {2012},
  doi     = {10.1056/nejmoa1106668},
  pmid    = {22397651},
  url     = {https://doi.org/10.1056/nejmoa1106668}
}

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How to read this study

Design: this is a trial. Participants are assigned to a treatment or a comparison, so the key questions are who was enrolled, whether the comparison group got a placebo or nothing, how long people were followed, and whether the result is on a measure that matters to patients or on a biomarker. Open-label and small trials can overstate benefit.
Size: the record gives no participant count. Look for one in the original before trusting a pattern.
Effect: the record gives no effect size, so the summary above cannot say how large any difference was.

What the evidence grade means here

This page is graded low. alzhub.org assigns the grade automatically from keywords in the abstract, not from reading the paper. Low means the abstract matched neither pattern. It is the default label, and it does not mean the work is poor; many sound lab and imaging papers land here. It can add at most 5 of the 100 points in the study score, and it is a label about design, not a verdict on whether the findings are true.

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Key findings

Results Patients assigned to continue donepezil, as compared with those assigned to discontinue donepezil, had a score on the SMMSE that was higher by an average of 1.9 points (95% confidence interval [CI], 1.3 to 2.5) and a score on the BADLS that was lower (indicating less impairment) by 3.0 points (95% CI, 1.8 to 4.3) (P<0.001 for both comparisons).
Patients assigned to receive memantine, as compared with those assigned to receive memantine placebo, had a score on the SMMSE that was an average of 1.2 points higher (95% CI, 0.6 to 1.8; P<0.001) and a score on the BADLS that was 1.5 points lower (95% CI, 0.3 to 2.8; P=0.02).
The efficacy of donepezil and of memantine did not differ significantly in the presence or absence of the other.
There were no significant benefits of the combination of donepezil and memantine over donepezil alone.
Conclusions In patients with moderate or severe Alzheimer's disease, continued treatment with donepezil was associated with cognitive benefits that exceeded the minimum clinically important difference and with significant functional benefits over the course of 12 months.

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Study details

Evidence strengthLow

How this study scored 67/100

Published in a top-tier journal, and it is a randomized controlled trial. Scored zero for sample size and 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 41 of the 61 points we could judge it on, which is 67 out of 100.

Component	Points	Why
Journal tier	10 / 10	Tier 1 — top-tier general journal (The New England journal of medicine)
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	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	2012 — within 20 year(s) of the newest study here
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)
Randomized / blinded	1 / 2	Randomized (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 22397651)
Free to read	0 / 2	Behind a paywall — scores zero
Points	41 / 61	Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 41 of the 61 points we could judge it on is 67 out of 100.
Total	67 / 100	—

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Where this led: Donepezil on the treatments page — its current status, approval date, side-effect rate and list price, kept up to date.

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