Trial reportGeroScience2026
Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD).
Trial report in GeroScience, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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.
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.
Who cites it
3 citing papers in PubMed.
- Effects ofFrontiers in nutrition · 2026Trial
- Eye-Tracking-Based Cognitive Assessment Predicts the Risk of Memory Decline: A Community-Based Cohort Study.Geriatrics & gerontology international · 2026Article
- An eye-tracking-based Stroop test: an efficient method for evaluating frontal lobe function.Frontiers in aging neuroscience · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Efficient screening tools for cognitive decline and dementia are in high demand. We previously reported on a novel cognitive assessment tool using eye-tracking technology and its utility in dementia screening. In this study, we developed a tablet version of the eye-tracking-based cognitive assessment (ETCA) app and conducted a clinical trial to verify its clinical utility as software as a medical device (SaMD). Participants with and without dementia were enrolled between December 1, 2020, and July 31, 2021. They used the ETCA app and completed the most widely applied screening test, the Mini-Mental State Examination (MMSE), on the same day. The primary outcome was the correlation between the ETCA and MMSE scores. The key secondary outcomes were the administration time for the ETCA, questionnaire-based assessments of test-related burdens, and correlations of the subscores. Performance for detecting dementia was evaluated exploratorily. Analyses of the full analysis set population revealed a strong positive correlation in total scores between the tests (r = 0.831; 95% CI, 0.743-0.891; p < 0.0001). The median ETCA administration time was 254.0 s, and more than 70% of participants reported experiencing less or a similar test-related burden with the ECTA app, compared to the MMSE. Significant correlations were observed for all subscores. The ETCA achieved an area under the curve of 0.864 in detecting participants with dementia. These results verified the clinical utility of the tablet-based ETCA app as a rapid cognitive assessment tool. Based on the results, the ETCA app has obtained regulatory approval as SaMD.
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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.