Trial0

Clinical trial · NCT07474038 · ENROLLING_BY_INVITATION · NA

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

Sponsor: Kaiser Permanente

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Summary

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.

Interventions

  • AI-Supported Cognitive Rehabilitation · BEHAVIORAL

    Participants receive a structured cognitive rehabilitation program consisting of (1) telehealth sessions delivered by licensed clinicians using a goal-directed cognitive rehabilitation framework and (2) daily AI-guided conversational cognitive exercises tailored to individual needs. The AI system provides cognitive stimulation, training exercises, and psychoeducation but does not perform diagnostic or autonomous clinical decision-making.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Age 65 years or older
* Diagnosis of mild cognitive impairment (MCI)
* Montreal Cognitive Assessment (MoCA)-BLIND adjusted score (13-18)
* Able to provide informed consent
* English fluency sufficient to complete study assessments and participate in intervention sessions
* Access to and ability to use a computer or mobile device with internet connectivity

Exclusion Criteria:

* Current receipt of ongoing behavioral health treatment or psychotherapy from a Kaiser Permanente clinician
* Diagnosis of bipolar disorder, schizophrenia spectrum disorder, or other serious mental illness that would interfere with participation
* Significant communication impairment that would prevent participation in conversational or telehealth sessions

Sites (1)

  • Kaiser Permanente Southern California, Pasadena, California

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-03-20.