AI-Supported Cognitive Rehabilitation for Older Adults With Mild Cognitive Impairment (ReMind-AI)

March 18, 2026 updated by: Huong Q Nguyen, Kaiser Permanente

Evaluating the Efficacy of AI-Augmented Cognitive Rehabilitation in 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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale:

Mild cognitive impairment (MCI) represents a transitional stage between normal aging and dementia and is associated with elevated risk of progression to Alzheimer's disease and related dementias. Individuals with MCI frequently report functional challenges, reduced confidence, and increased risk of mood symptoms. Although cognitive rehabilitation and cognitive stimulation interventions have demonstrated benefit, traditional models are resource-intensive and limited in frequency, personalization, and scalability.

Advances in artificial intelligence (AI) allow delivery of adaptive, conversational, and personalized cognitive exercises at high frequency. However, AI-only approaches may lack the contextualization, goal-setting support, and therapeutic oversight provided by trained clinicians. A blended care model integrating AI-guided cognitive exercises with clinician-delivered telehealth rehabilitation may provide both scalability and clinical depth. This study evaluates the safety, engagement, and clinical efficacy of such an integrated model.

Study Design:

This is a prospective, randomized parallel controlled trial conducted within Kaiser Permanente Southern California. Participants diagnosed with MCI through an existing cognitive assessment research program will be randomized in a 1:1 ratio to:

  • AI-supported cognitive rehabilitation
  • Usual care alone

The intervention period is 12 months, with primary outcome assessment at 6 months and follow-up through 12 months.

Intervention:

Participants randomized to the intervention will receive a structured cognitive rehabilitation program consisting of two integrated components:

  1. Clinician-Delivered Telehealth Rehabilitation Licensed clinical social workers trained in cognitive rehabilitation will deliver goal-directed sessions via telehealth every two weeks for the first six months and monthly for the remaining six months. Sessions are delivered within a reablement framework and may incorporate cognitive rehabilitation techniques, behavioral activation, compensatory strategy training, and elements of cognitive behavioral and mindfulness-based approaches, tailored to individual patient needs.
  2. AI-Guided Cognitive Sessions Participants will engage in daily AI-powered conversational sessions (approximately 10-30 minutes per session). These sessions provide structured cognitive stimulation, cognitive training exercises, and psychoeducation. Content delivery is guided by algorithms that adapt based on participant interaction patterns and clinician input. The AI system is not intended for diagnostic or autonomous clinical decision-making.

Participants randomized to usual care will continue to receive standard health plan services and complete study assessments at scheduled time points. They will be offered the cognitive rehabilitation program at the end of the study if the intervention is determined to be safe and efficacious.

Safety Oversight and Risk Monitoring:

Given the use of AI-based conversational technology in a cognitively vulnerable population, safety monitoring procedures are integrated at multiple levels:

  • Licensed clinicians monitor participant progress and well-being throughout the intervention period.
  • AI interactions are reviewed for safety concerns, including indicators of psychological distress.
  • Predefined escalation procedures are in place for emergent behavioral health risk, including referral to appropriate clinical services and crisis resources.
  • Technical concerns or adverse events are tracked and reviewed by the study team.
  • The principal investigator oversees participant safety and protocol adherence in accordance with IRB and Good Clinical Practice standards.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91101
        • Kaiser Permanente Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MoCA-BLIND Score at 6 Months
Time Frame: 6 months
Change from baseline to 6 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Global Cognition (MoCA-BLIND)
Time Frame: 12 months
Change from baseline to 12 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.
12 months
Change in Global Cognition (ACE-III)
Time Frame: 6 months and 12 months
Change from baseline to 6 months and baseline to 12 months in total score on the Addenbrooke's Cognitive Examination-III (ACE-III).
6 months and 12 months
Change in Subjective Memory
Time Frame: 6 months and 12 months
Change from baseline to 6 months and baseline to 12 months in Ability and Satisfaction subscale scores of the Multifactorial Memory Questionnaire (MMQ).
6 months and 12 months
Change in Mood Symptoms
Time Frame: 6 months and 12 months
Change from baseline to 6 months and baseline to 12 months in scores on the Geriatric Anxiety Inventory (GAI) and Geriatric Depression Scale (GDS)
6 months and 12 months
Change in Loneliness
Time Frame: 6 months and 12 months
Change from baseline to 6 months and baseline to 12 months in total score on the UCLA Loneliness Scale.
6 months and 12 months
Change in Goal Attainment
Time Frame: 6 months and 12 months
Change from baseline to 6 months and baseline to 12 months in participant-reported satisfaction scores on the Bangor Goal-Setting Interview.
6 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement with AI-supported cognitive rehabilitation
Time Frame: Baseline through 12 months
Participant engagement with the AI-supported cognitive rehabilitation intervention as measured by the number of AI sessions completed, number of clinician-supported telehealth sessions attended, and completion of assigned cognitive exercises during the intervention period.
Baseline through 12 months
Participant acceptability and satisfaction with the intervention
Time Frame: 6 months and 12 months
Participant-reported satisfaction and perceived usefulness of the AI-supported cognitive rehabilitation intervention as measured by post-intervention survey ratings.
6 months and 12 months
Safety events and clinical escalation events related to AI interactions
Time Frame: Baseline through 12 months
Number and type of safety events during the study, including AI-generated safety alerts, clinician-reviewed safety flags, escalation events requiring clinical follow-up, and documented adverse events related to interactions with the AI intervention.
Baseline through 12 months
Medication adherence (diabetes and hypertension)
Time Frame: Baseline through 12 months
Medication adherence as measured using electronic health record-derived pharmacy refill data, including proportion of days covered (PDC) for prescribed medications during the study period.
Baseline through 12 months
Blood pressure and glycemic control
Time Frame: Baseline through 12 months
Change from baseline to 12 months in systolic blood pressure, diastolic blood pressure, and hemoglobin A1c (HbA1c) levels obtained from the electronic health record.
Baseline through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

NewDays, Inc.

Investigators

  • Principal Investigator: Huong Nguyen, PhD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Cognitive Impairment (MCI)

Clinical Trials on AI-Supported Cognitive Rehabilitation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe