Evidence map›Paper›PMID 35796268›Full record

ArticleJournal of clinical neurology (Seoul, Korea)2022

A Multinational, Multicenter, Randomized, Double-Blind, Active Comparator, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Donepezil Transdermal Patch in Patients With Alzheimer's Disease.

Hyun Jeong Han, Mee Young Park, Kyung Won Park, Kee Hyung Park, Seong Hye Choi, Hee-Jin Kim, Dong Won Yang, Esther Gunaseli A/P M Ebenezer, Yuan-Han Yang, Gurudev M Kewalram and 2 more

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical neurology (Seoul, Korea), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.9field-weighted citation impact, top 27% of its field
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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
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

12 authors at 10 institutions in 4 countries.

Hyun Jeong HanDepartment of Neurology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea.ORCID https://orcid.org/0000-0002-1129-6340
Mee Young ParkDepartment of Neurology, Yeungnam University Medical Center, Daegu, Korea.ORCID https://orcid.org/0000-0002-5683-1634
Kyung Won ParkDepartment of Neurology, Dong-A Medical Center, Dong-A University College of Medicine, Busan, Korea.ORCID https://orcid.org/0000-0002-6788-5267
Kee Hyung ParkDepartment of Neurology, College of Medicine, Gachon University Gil Medical Center, Incheon, Korea.ORCID https://orcid.org/0000-0001-6847-6679
Seong Hye ChoiDepartment of Neurology, Inha University School of Medicine, Incheon, Korea.ORCID https://orcid.org/0000-0002-4180-8626
Hee-Jin KimDepartment of Neurology, Hanyang University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0001-7880-690X
Dong Won YangDepartment of Neurology, The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, Korea.ORCID https://orcid.org/0000-0002-4733-7298
Esther Gunaseli A/P M EbenezerHospital Raja Permaisuri Bainun, Palac, Malaysia.ORCID https://orcid.org/0000-0003-4948-3368
Yuan-Han YangKaohsiung Municipal Ta-Tung Hospital, Kaohsiung, Taiwan.ORCID https://orcid.org/0000-0002-1918-9021
Gurudev M KewalramPrince Charles Hospital, Brisbane, Australia.ORCID https://orcid.org/0000-0002-5137-7313
Seol-Heui HanDepartment of Neurology, Konkuk University School of Medicine and Konkuk University Medical Center, Seoul, Korea. alzdoc@kuh.ac.kr.ORCID https://orcid.org/0000-0003-3608-2514
on Behalf the IPI-301 Study
Gachon University Gil Medical Center · KRHanyang University · KRInha University · KRKaohsiung Municipal Ta-Tung Hospital · TWKonkuk University Medical Center · KRMyongji Hospital · KRPrince Charles Hospital · AUThe Catholic University of Korea Seoul St. Mary's Hospital · KRUral Branch of the Russian Academy of Sciences · RUYeungnam University Medical Center · KR

Funding

iCure Pharmaceutical Incorporated
6 · The paper itself

Abstract

background and purposeOral administration of cholinesterase inhibitors is often associated with adverse gastrointestinal effects, and so developing an alternative administration route, such as transdermal, is urgently needed. The primary objective of this study was to determine the efficacy and safety of the IPI-301 donepezil transdermal patch compared with donepezil tablets (control) in mild-to-moderate probable Alzheimer's disease (AD).

methodsThis prospective, randomized, double-blind, double-dummy, two-arm parallel, multicenter trial included 399 patients, among whom 303 completed the trial. For randomization, the patients were stratified based on previous treatment and donepezil dose; patients in each stratum were randomized to the test and control groups at a 1:1 ratio.

resultsThe difference between the control group and the IPI-301 group, quantified as the Hodges-Lehmann estimate of location shift, was 0.00 (95% confidence interval: -1.00 to 1.33), with an upper limit of less than 2.02. The change in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) score differed significantly between the IPI-301 and control groups (

conclusionsIPI-301 was safe and efficacious in improving cognitive function in patients with mild-to-moderate AD.

Indexed as

acetylcholinesterase inhibitorAlzheimer's diseasedonepezil transdermal patchefficacysafety

Identifiers

PMID35796268
PMCPMC9262446
OpenAlexW4284897404

What OpenQuestion holds

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LicenceCC BY-NC
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 OpenQuestion graph.