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

Part of paid clinical trials in Pasadena, California.

Sponsor
Kaiser Permanente
Study ID
NCT07474038
Status
Enrolling By Invitation

Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 16, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual Care
    Participants will continue to receive usual health care and services available through their Kaiser Permanente health plan and will complete study assessments at 6 and 12 months.
  • Experimental: AI-Supported Cognitive Rehabilitation
    Participants will receive a 12-month cognitive rehabilitation program that integrates clinician-delivered telehealth sessions with daily artificial intelligence (AI)-guided cognitive exercises.

Primary Outcome Measure

Change in MoCA-BLIND Score at 6 Months [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Kaiser Permanente Southern CaliforniaPasadenaCalifornia91101-

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Kaiser Permanente Southern California· Pasadena, CA

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