Mild Cognitive Impairment (MCI)ReMind-AINCT07474038
AI-Supported Cognitive Rehabilitation for Older Adults With Mild Cognitive Impairment
A study testing AI-Supported Cognitive Rehabilitation in people with Mild Cognitive Impairment (MCI), run by Kaiser Permanente at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- AI-Supported Cognitive Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Official title: 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.
Read more
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.
Read the 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:
- 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.
- 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.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- AI-Supported Cognitive Rehabilitation
- Keywords
- Artificial Intelligence, Cognitive Rehabilitation, Digital Health Intervention, Dementia Prevention, Cognitive Training, Conversational AI, telehealth
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Supported Cognitive RehabilitationBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AI-Supported Cognitive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MoCA-BLIND Score at 6 Months
Change from baseline to 6 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.
Measured: 6 months
Secondary outcomes (6)
Change in Global Cognition (MoCA-BLIND)
Change from baseline to 12 months on the Montreal Cognitive Assessment (MoCA)-BLIND adjusted total score.
Measured: 12 months
Change in Global Cognition (ACE-III)
Change from baseline to 6 months and baseline to 12 months in total score on the Addenbrooke's Cognitive Examination-III (ACE-III).
Measured: 6 months and 12 months
Change in Subjective Memory
Change from baseline to 6 months and baseline to 12 months in Ability and Satisfaction subscale scores of the Multifactorial Memory Questionnaire (MMQ).
Measured: 6 months and 12 months
Change in Mood Symptoms
Change from baseline to 6 months and baseline to 12 months in scores on the Geriatric Anxiety Inventory (GAI) and Geriatric Depression Scale (GDS)
Measured: 6 months and 12 months
Change in Loneliness
Change from baseline to 6 months and baseline to 12 months in total score on the UCLA Loneliness Scale.
Measured: 6 months and 12 months
Change in Goal Attainment
Change from baseline to 6 months and baseline to 12 months in participant-reported satisfaction scores on the Bangor Goal-Setting Interview.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start16 Mar 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio using block randomization to receive either AI-supported cognitive rehabilitation or usual care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- NewDays, Inc.
- Responsible party
- Principal investigator, Huong Q Nguyen, Kaiser Permanente
- Investigators
- Huong Nguyen, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474038
- Sponsor's protocol ID
- 14432
- Acronym
- ReMind-AI
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of AI-Augmented Cognitive Rehabilitation in Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07474038
- Acronym / sponsor ID
- ReMind-AI / 14432
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Artificial Intelligence, Cognitive Rehabilitation, Digital Health Intervention, Dementia Prevention, Cognitive Training, Conversational AI, telehealth
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- NewDays, Inc.
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio using block randomization to receive either AI-supported cognitive rehabilitation or usual care.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: AI-Supported Cognitive RehabilitationParticipants will receive a 12-month cognitive rehabilitation program that integrates clinician-delivered telehealth sessions with daily artificial intelligence (AI)-guided cognitive exercises. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Supported Cognitive RehabilitationParticipants 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. | Behavioural | AI-Supported Cognitive Rehabilitation |
Primary outcome
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 secondary outcomes
Change in Global Cognition (MoCA-BLIND)
Time frame: 12 months
Change in Global Cognition (ACE-III)
Time frame: 6 months and 12 months
Change in Subjective Memory
Time frame: 6 months and 12 months
Change in Mood Symptoms
Time frame: 6 months and 12 months
Change in Loneliness
Time frame: 6 months and 12 months
Change in Goal Attainment
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huong Nguyen, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Supported Cognitive Rehabilitation in people with Mild Cognitive Impairment (MCI), run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MoCA-BLIND Score at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.