Evidence map›Paper›PMID 42411945›Full record

Observational studyAlzheimer disease and associated disorders

Post Hoc Subgroup Analysis by Disease Severity in a Non-Inferiority Trial of Donepezil 27.5 mg Transdermal Formulation in Japanese Patients With Mild-to-Moderate Alzheimer Disease.

Yu Nakamura, Takuma Tsushio, Masaya Tanahashi, Hideki Suganami, Takumi Omori, Kenichi Nishiyama, Hiroshi Aoki, Naoki Nagakura

Abstract readObservational Study
In one paragraph

Observational study in Alzheimer disease and associated disorders. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Yu NakamuraDepartment of Neuropsychiatry, Faculty of Medicine, Kagawa University.
Takuma TsushioDepartment of Clinical Data Science, Data Science Center, Kowa Company, Ltd., Chuo-ku, Tokyo, Japan.
Masaya TanahashiDepartment of Clinical Data Science, Data Science Center, Kowa Company, Ltd., Chuo-ku, Tokyo, Japan.
Hideki SuganamiDepartment of Clinical Data Science, Data Science Center, Kowa Company, Ltd., Chuo-ku, Tokyo, Japan.
Takumi OmoriDepartment of Clinical Development.
Kenichi NishiyamaDepartment of Clinical Development.
Hiroshi AokiDepartment of Clinical Development.
Naoki NagakuraMedical Affairs, Teikoku Seiyaku Co., Ltd., Kagawa.

Funding

Teikoku Seiyaku
6 · The paper itself

Abstract

backgroundThe efficacy of cholinesterase inhibitors varies depending on the severity of Alzheimer disease. We examined the effects of the disease severity on the efficacy of donepezil 27.5 mg patches in Japanese patients with Alzheimer disease.

methodsA post hoc analysis of covariance using per-protocol set in a noninferiority study of donepezil 27.5 mg patches with donepezil hydrochloride 5 mg tablets (JapicCTI-194582) was conducted after imputation of missing data using multiple imputations.

resultsNo apparent imbalances in the extracted confounding factors were observed between the 2 treatment groups. The baseline value of the Alzheimer Disease Assessment Scale (Japanese version) cognitive subscale was adjusted using analysis of covariance. Least-squares mean of changes from baseline in the Alzheimer Disease Assessment Scale (Japanese version) cognitive subscale at week 24 for each group were -1.661 (-2.681 to -0.640) (donepezil patch) and 0.065 (-0.987 to 1.117) (donepezil hydrochloride tablet). The difference in the least-squares mean (95% CI) between 2 groups was -1.726 (-3.1913 to -0.2602, P =0.021).

conclusionsA post hoc analysis of covariance using the per-protocol set suggested that donepezil patches may be more effective than donepezil tablets in slowing cognitive decline in patients with mild Alzheimer disease.

Indexed as

Alzheimer DiseaseCholinesterase InhibitorsDonepezilAdministration, CutaneousAgedAged, 80 and overEast Asian PeopleEquivalence Trials as TopicFemaleHumansJapanMaleRandomized Controlled Trials as TopicSeverity of Illness IndexTransdermal PatchTreatment OutcomeCholinesterase InhibitorsDonepezilAlzheimer diseasecholinesterase inhibitorscognitiondisease severitydonepezilpatches

Identifiers

PMID42411945
PMCPMC13552568

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.