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

NCT07474038 | Enrolling By Invitation

• 1 other identifier: 14432
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Artificial Intelligence; Cognitive Rehabilitation; Digital Health Intervention; Dementia Prevention; Cognitive Training; Conversational AI; telehealth

Outcome Measures

Primary Outcomes (1)

• Change in MoCA-BLIND Score at 6 Months

  Change from baseline to 6 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.

  6 months

Secondary Outcomes (6)

• Change in Global Cognition (MoCA-BLIND)

  12 months

• Change in Global Cognition (ACE-III)

  6 months and 12 months

• Change in Subjective Memory

  6 months and 12 months

• Change in Mood Symptoms

  6 months and 12 months

• Change in Loneliness

  6 months and 12 months

Other Outcomes (5)

• Engagement with AI-supported cognitive rehabilitation

  Baseline through 12 months

• Participant acceptability and satisfaction with the intervention

  6 months and 12 months

• Safety events and clinical escalation events related to AI interactions

  Baseline through 12 months

Study Arms (2)

Usual Care

NO INTERVENTION

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.

AI-Supported Cognitive Rehabilitation

EXPERIMENTAL

Participants will receive a 12-month cognitive rehabilitation program that integrates clinician-delivered telehealth sessions with daily artificial intelligence (AI)-guided cognitive exercises.

Behavioral: AI-Supported Cognitive Rehabilitation

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.

AI-Supported Cognitive Rehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• NewDays, Inc.: collaborator

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Huong Nguyen, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and the Principal Investigator will remain blinded to treatment assignment. Intervention delivery will be conducted by designated unblinded study personnel who are not involved in outcome assessment or outcome analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist III

Model Details: Participants will be randomized in a 1:1 ratio using block randomization to receive either AI-supported cognitive rehabilitation or usual care.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)