Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD)

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.