Evidence map›Paper›PMID 41554532›Full record

Trial reportJMIR mHealth and uHealth2026

Efficacy and Safety of Mobile App-Based Metamemory Cognitive Training for Mild Cognitive Impairment: Multicenter Randomized Clinical Trial.

Sunyoung Kang, Jung-In Lim, Lukas Stenzel, Keun You Kim, Eosu Kim, Hong Jun Jeon, Doo-Heum Park, Hyun Kook Lim, YongSoo Shim, Jae-Won Jang and 3 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in JMIR mHealth and uHealth, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05938426 (Digital Therapeutics), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
–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.

NCT05938426 naunknown statusnot on this map

Digital Therapeutics (ET-101) Research on Efficiency and Safety About Mild Cognitive Impairment, Randomized, Sham Device, Assessor-blinded, Multi-center Pivotal Study

TypeinterventionalSponsorEmocog Inc.Ran2023 to 2024Enrolled100ConditionsMild Cognitive ImpairmentArmsET-101, Sham Device
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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

13 authors.

Sunyoung KangDepartment of Psychiatry & Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0009-0008-1058-3306
Jung-In LimInterdisciplinary Program in Cognitive Science, Seoul National University, Seoul, Republic of Korea.ORCID 0009-0007-0696-4424
Lukas StenzelCogthera GmbH, Munich, Germany.ORCID 0000-0002-6320-9085
Keun You KimDepartment of Psychiatry & Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0001-7192-2828
Eosu KimDepartment of Psychiatry & Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.ORCID 0000-0001-9472-9465
Hong Jun JeonDepartment of Psychiatry, Konkuk University Medical Center, Seoul, Republic of Korea.ORCID 0000-0002-0260-0494
Doo-Heum ParkDepartment of Psychiatry, Konkuk University Medical Center, Seoul, Republic of Korea.ORCID 0000-0002-4833-5366
Hyun Kook LimDepartment of Psychiatry, Yeouido St. Mary's Hospital, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0001-8742-3409
YongSoo ShimDepartment of Neurology, St. Vincent's Hospital, College of Medicine, Catholic University of Korea, Seoul, Republic of Korea.ORCID 0000-0001-5642-5401
Jae-Won JangDepartment of Neurology, Kangwon National University Hospital, College of Medicine, Kangwon National University, Chuncheon, Gangwon-do, Republic of Korea.ORCID 0000-0003-3540-530X
Yeshin KimDepartment of Neurology, Kangwon National University Hospital, College of Medicine, Kangwon National University, Chuncheon, Gangwon-do, Republic of Korea.ORCID 0000-0002-4643-5478
Sanghoon LeeEmocog Inc., Seoul, Republic of Korea.ORCID 0009-0009-0665-0462
Kee Hyung ParkDepartment of Neurology, College of Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea.ORCID 0000-0001-6847-6679

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMetamemory training (MMT) offers a potential nonpharmacological approach to enhance cognitive function in individuals with mild cognitive impairment (MCI). While digital cognitive training improves accessibility, the effectiveness of mobile app-based MMT has not been evaluated in a randomized clinical trial.

objectiveWe aimed to evaluate the efficacy and safety of a mobile app-based MMT program, ET-101 (Cogthera), compared to a sham device control group in individuals with MCI.

methodsThis multicenter, randomized controlled trial enrolled participants with MCI, recruited from 7 medical centers, and randomly assigned them to the ET-101 or control group (1:1 ratio). The intervention lasted 12 weeks, with a 12-week follow-up. The ET-101 group received metamemory-based multimemory strategy training and real-time feedback. Assessments of cognition, the daily activities of living, and the quality of life were conducted at baseline, week 12, and week 24. The primary outcome was the proportion of participants who showed cognitive improvement as assessed by the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)-14 at weeks 12 and 24. Secondary outcomes included changes in the scores of scales assessing cognition, daily activities, and quality of life. Safety analysis assessed adverse events and their relation to digital therapeutics.

resultsIn the full analysis set, 49 participants were included in the ET-101 group and 50 in the control group. At week 24, the proportion of responders who maintained or improved their ADAS-Cog-14 scores was significantly higher in the ET-101 group than in the control group (P=.002). Additionally, the ET-101 group showed a significant improvement in ADAS-Cog-14 scores at week 24 compared to baseline levels (estimates=-2.53; t

conclusionsET-101 significantly improved cognitive function compared to the sham device, with effects observed not only in the memory domain but also in the language domain, indicating a transfer effect. Therefore, ET-101 has the potential to provide effective MMT to a broader population with MCI by overcoming location and personnel limitations through a mobile app-based platform.

trial registrationClinicalTrials.gov NCT05938426; https://clinicaltrials.gov/study/NCT05938426.

Indexed as

Cognitive Behavioral TherapyCognitive DysfunctionMobile ApplicationsAgedAged, 80 and overCognitive TrainingFemaleHumansMaleMiddle AgedNeuropsychological TestsQuality of LifeTreatment Outcomecognitive declinecognitive trainingdigital therapeuticsmild cognitive impairmentmobile app–based cognitive training

Identifiers

PMID41554532
PMCPMC12865355

What OpenQuestion holds

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Registered trials

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.