AI-Supported Cognitive Rehabilitation for Older Adults With Mild Cognitive Impairment

Mild cognitive impairment (MCI) is associated with increased risk of progression to dementia, highlighting the need for accessible interventions to support cognitive health. This randomized controlled trial will evaluate the safety and efficacy of a 12-month artificial intelligence (AI)-supported cognitive rehabilitation program for older adults with MCI. Participants will be recruited from an existing research study conducted within Kaiser Permanente Southern California and randomized 1:1 to either (1) AI-supported cognitive rehabilitation or (2) usual care alone. The intervention combines clinician-delivered telehealth cognitive rehabilitation sessions with daily AI-guided cognitive exercises and education. The primary outcome is change in global cognition at 6 months measured by the Montreal Cognitive Assessment (MoCA)-BLIND. Secondary outcomes at 6 and 12 months include additional measures of cognition, subjective memory, goal attainment, mood, and loneliness. Exploratory outcomes include engagement with the AI intervention and health-related behavioral outcomes derived from electronic health record data. Participant safety will be monitored throughout the study through adverse event tracking, review of AI interactions for safety concerns, and predefined procedures for responding to psychological or clinical risk. This study will determine whether integrating AI-guided cognitive exercises with clinician-delivered rehabilitation improves cognitive and related outcomes in older adults with MCI compared to usual care.

NCT Number	NCT07474038
Lead Sponsor	Kaiser Permanente Collaborators: NewDays, Inc.
Conditions	Mild Cognitive Impairment (MCI)
Enrollment	130 participants
Start Date	2026-03-16
Primary Completion	2027-09-30 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-03-20