Kaiser Permanente Southern California
Pasadena, California, 91101, United States
NCT Number: NCT07474038
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Pasadena, California, 91101, United States
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:
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:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
Change from baseline to 6 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.
Time frame: 12 months
Change from baseline to 12 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.
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).
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).
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)
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.
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.
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.
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.
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.
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.
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.
Kaiser Permanente
Other
Evaluating the Efficacy of AI-Augmented Cognitive Rehabilitation in Mild Cognitive Impairment
Acronym: ReMind-AI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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