This page is alzhub.org's plain-English summary of a published study, not the paper itself. It is generated from the record we hold for this study, sourced and linked below — check the original for the full text and methods.

52/100

✓ Peer-reviewed alzhub usefulness score 52 out of 100. Treatments

Topic: Drug trials: efficacy and safety

Plain-language summary

In total, 100 subjects completed the study. Cognitive function improvement was sustained for 52 weeks (MMSE at week 52 in 10 mg: 2.8 ± 3.5 (mean ± standard deviation); P <0.001, Student paired t test)). Those who received placebo in the RCT phase showed an improvement after starting active treatment. NPI improved in all the groups throughout the study, including the placebo period. In the subgroup of the 5 mg group without remarkable cognitive or behavioral improvement at week 24, further improvement was observed after a dose increase to 10 mg. After week 24, 21 patients experienced dose reduction. The incidence of any AEs did not increase over time. The long-term administration of donepezil at 10 mg/day improved cognitive function for up to 52 weeks in patients with DLB without increasing the risk of clinically significant safety events. Trial registration: NCT01278407 . Trial registration date: January 14, 2011.

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

APA 7th

Mori, E., Ikeda, M., Nagai, R., Matsuo, K., Nakagawa, M., & Kosaka, K. (2015). Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. Alzheimer's Research & Therapy. https://doi.org/10.1186/s13195-014-0081-2

Vancouver

Mori E, Ikeda M, Nagai R, Matsuo K, Nakagawa M, Kosaka K. Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial. Alzheimer's Research & Therapy. 2015. doi:10.1186/s13195-014-0081-2.

BibTeX

@article{mori2015-88c17657,
  author  = {Mori, Etsuro and Ikeda, Manabu and Nagai, Reiko and Matsuo, Kazutaka and Nakagawa, Masaki and Kosaka, Kenji},
  title   = {{Long-term donepezil use for dementia with Lewy bodies: results from an open-label extension of Phase III trial}},
  journal = {Alzheimer's Research \& Therapy},
  year    = {2015},
  doi     = {10.1186/s13195-014-0081-2},
  url     = {https://doi.org/10.1186/s13195-014-0081-2}
}

Built from the record alzhub holds for this paper, not looked up. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.

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 lists 100 participants. Ask whether that is enough for the question, and who they were.
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 high. alzhub.org assigns the grade automatically from keywords in the abstract, not from reading the paper. High means the abstract mentions a randomized design, a meta-analysis or a systematic review. 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.

New to reading papers? Six questions to ask of any Alzheimer’s study · how we score.

Key findings

In total, 100 subjects completed the study.
Cognitive function improvement was sustained for 52 weeks (MMSE at week 52 in 10 mg: 2.8 ± 3.5 (mean ± standard deviation); P <0.001, Student paired t test)).
Those who received placebo in the RCT phase showed an improvement after starting active treatment.
NPI improved in all the groups throughout the study, including the placebo period.
In the subgroup of the 5 mg group without remarkable cognitive or behavioral improvement at week 24, further improvement was observed after a dose increase to 10 mg.

New to this subject? Start with our plain-English guide: Treatments →

Study details

Study designclinical trial
Participants100
Evidence strengthHigh

How this study scored 52/100

Published in a peer-reviewed journal. Scored zero for study design, effect reported and randomized / blinded 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, institution's track record, multicenter collaboration and free to read, so those were left out: it earned 29 of the 56 points we could judge it on, which is 52 out of 100.

Component	Points	Why
Journal tier	7 / 10	Tier 3 — peer-reviewed journal (Alzheimer's Research & Therapy)
Journal's citation record	— / 4	No journal record from OpenAlex — left out of this score
Study design	0 / 12	Design recorded as “clinical trial”, which our rubric does not rank (not stated in the record — scored 0)
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	2015 — within 20 year(s) of the newest study here
Sample size	2 / 4	100 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	0 / 2	No randomization or blinding stated — scores zero (not stated in the record — scored 0)
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	— / 3	Institutions not listed — left out of this score
Indexed in PubMed	1 / 2	Not in PubMed, but has a DOI
Free to read	— / 2	Access not recorded — left out of this score
Points	29 / 56	Scored on 10 of 20 parts. We have no data for the rest, so they are left out: 29 of the 56 points we could judge it on is 52 out of 100.
Total	52 / 100	—

What each of these 20 components measures, and what this score is not →

Read the original

Free copy unknown: no free-copy check has an answer for this record yet. That does not mean it is paywalled.

Studies in the library that share something with this one. The line above each title says what.

Related studies in Treatments from nearby years

Also tagged “cholinesterase”

271 studies in the library carry the topic tag “cholinesterase”; these are this study's neighbours in a fixed, alphabetical-by-hash tour of them, not the closest in content. All 271 tagged studies.

Studies sharing this one's topic tags

Similar studies

More on Treatments

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

See all studies in Treatments →