Effects of a Structured Cognitive-Based Intervention in Older Adults With Mild Cognitive Impairment: A Randomized Clinical Trial

Abstract Background Evidence remains limited on whether structured cognitive training provides additional benefit when added to multimodal non-pharmacological programs for older adults with mild cognitive impairment (MCI). Methods In this randomized controlled trial, 631 older adults were screened for eligibility, 161 met the study criteria, and 146 were enrolled and randomized 1:1 to the intervention or active control group (73 per group) using computer-generated block randomization with block sizes of 4 and 6. Both groups received cognitive-health education, home-based cognitive activities, and standardized physical exercise. The intervention group additionally received 12 weeks of supervised structured multidomain cognitive training with individualized starting levels and progressive adjustment of task difficulty. The primary outcome was change in Montreal Cognitive Assessment (MoCA) total score from baseline to 3 and 12 months, analyzed using intention-to-treat linear mixed-effects models. Results The intervention group showed greater improvement in MoCA total score than the control group at 3 months (β = 0.525; 95%CI, 0.227 to 0.822; p = 0.001) and 12 months (β = 1.627; 95%CI, 1.325 to 1.929; p < 0.001). Per-protocol findings were consistent. No consistent between-group differences were observed for depressive symptoms, instrumental functioning, or physical performance. Exploratory analyses suggested greater improvement in attention at both follow-ups and in language and abstraction at 12 months. Conclusion Adding structured multidomain cognitive training to a shared multimodal program resulted in greater improvement in global cognition at both follow-ups. Further pragmatic evaluation of this noncomputerized approach in routine and resource-constrained settings is warranted. Trial registration: The trial was registered at ClinicalTrials.gov (registration number: NCT06453746; June 12, 2024), available at https://clinicaltrials.gov/study/NCT06453746.