Abstract
OBJECTIVE: The aim of the study is to evaluate the efficacy of a karaoke-based digital therapeutic program (CogniSong) in patients with mild cognitive impairment (MCI). METHODS: In a 12-week single-center, assessor-blinded randomized controlled trial, 36 patients with MCI were randomly assigned to either the CogniSong digital therapeutics (DTx) group (n=18) or standard treatment group (n=18). The intervention group underwent daily 30-minute karaoke game-based cognitive training sessions via a mobile application. The primary outcome was the change in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) total score from baseline to week 12. Secondary outcomes included RBANS subdomain index scores, the Seoul-Instrumental Activities of Daily Living, 17-item Hamilton Depression Rating Scale, Neuropsychiatric Inventory, and Clinical Dementia Rating-Sum of Boxes. RESULTS: The DTx group showed a significantly greater improvement in RBANS total score compared to standard treatment group (mean change +5.9 points vs. -0.2 points, p=0.041). However, there were no significant between-group differences in RBANS subdomain scores or secondary outcomes such as daily functioning, mood, neuropsychiatric symptoms, or global clinical status. CONCLUSION: In this randomized controlled trial, a karaoke-based DTx appeared feasible and effective in enhancing global cognition in MCI. The findings support its potential as a complementary intervention for cognitive improvement in MCI patients.