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Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD)
Yoichi Takami, Tetsuro Miki, Yasushi Takeya, Hiromi Rakugi, Ryuichi Morishita, Shuko Takeda. GeroScience, 2025-10-20
Topic: Risk, prevention and care in population studies
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.
Key findings
- 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.
- 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.
Why it matters
This clinical trial found that a tablet-based eye-tracking cognitive assessment correlated strongly with the Mini-Mental State Examination and was well tolerated. It supports the tool's utility for rapid cognitive screening, but it does not test any treatment, cure, or prevention for Alzheimer's disease.
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Study details
- Evidence strengthLow
How this study scored 35/100
Published in a peer-reviewed journal. Scored zero for study design, sample size, effect reported, studied in people and randomised / blinded because the record does not state it.
| Component | Points | Why |
|---|---|---|
| Journal tier | 7 / 10 | Tier 3 — peer-reviewed journal (GeroScience) |
| Journal's citation record | 1 / 4 | GeroScience: journal h-index 83 (OpenAlex, 2026-10-29) |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 1 / 5 | Rated “low” in our summary |
| Peer-review validation | 10 / 10 | Peer-reviewed. Published as an article in a named peer-reviewed journal. |
| How recent | 4 / 5 | 2025 — within 3 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 0 / 3 | No effect size reported — scores zero (not stated in the record — scored 0) |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | 1 / 7 | Cited 3 times (OpenAlex, 2026-10-10) |
| Citations per year | 1 / 5 | 1.0 citations a year over 3 year(s) since 2025 |
| Impact for its field and year | 2 / 6 | Cited 1.9× the average for papers of its field and year (OpenAlex FWCI) |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | 1 / 4 | Cited 3 times in 2024–2026 (2026 still in progress; OpenAlex) |
| Senior author's track record | 2 / 4 | Last-listed author Shuko Takeda: h-index 35 (OpenAlex, whole career) |
| Institution's track record | 1 / 3 | The University of Osaka: institution h-index 1,138 (OpenAlex) |
| Multi-centre collaboration | 0 / 3 | OpenAlex lists 1 institution(s) in 1 country — scores zero (affiliation lists can be incomplete) |
| Indexed in PubMed | 2 / 2 | Indexed in PubMed (PMID 41116086) |
| Free to read | 2 / 2 | Free to read |
| Total | 35 / 100 | — |
What each of these 20 components measures, and what this score is not →
Read the original
Full text: free to read — OpenAlex lists this copy as free to read: the link above (checked 6 Feb 1020).
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
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.
APA 7th
Takami, Y., Miki, T., Takeya, Y., Rakugi, H., Morishita, R., & Takeda, S. (2025). Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience. https://doi.org/10.1007/s11357-025-01941-x
Vancouver
Takami Y, Miki T, Takeya Y, Rakugi H, Morishita R, Takeda S. Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience. 2025. doi:10.1007/s11357-025-01941-x. PMID: 41116086.
BibTeX
@article{takami2025-41116086,
author = {Takami, Yoichi and Miki, Tetsuro and Takeya, Yasushi and Rakugi, Hiromi and Morishita, Ryuichi and Takeda, Shuko},
title = {{Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD)}},
journal = {GeroScience},
year = {2025},
doi = {10.1007/s11357-025-01941-x},
pmid = {41116086},
url = {https://doi.org/10.1007/s11357-025-01941-x}
}
Studies this one cites
Referenced by this study and also in the alzhub library, so you can read them here.