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

NCT07474038 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Mild Cognitive Impairment (MCI)

Interventions

BEHAVIORAL

AI-Supported Cognitive Rehabilitation

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.

Sponsors & Collaborators

  • NewDays, Inc.

    collaborator UNKNOWN

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Huong Nguyen, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474038 on ClinicalTrials.gov