Mild Cognitive Impairment (MCI)AI-CONECTNCT07701668
AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults
A study testing AI-based conversational intervention in people with Mild Cognitive Impairment (MCI) and Social Isolation, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Social Isolation
- What is being tested?
- AI-based conversational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2028
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 75+
- Clinical diagnosis of MCI (any subtype) or, when a clinical diagnosis is unavailable, a Telephone-MoCA (T-MoCA) score of 15-17.
- Identified as socially isolated, defined as meeting both of the following self-reported criteria: (a) lives alone in one's own residence, and (b) engages in conversations lasting 30 minutes or longer no more than twice per week.
- GDS-15 (15-item Geriatric Depression Scale) at/below 9 (not severely depressed).
- Social self-efficacy mean ≤ 8 (on the 0-10 scale) across the 6-item Social Self-Efficacy Scale at screening, indicating low confidence in social interaction.
- Ability to understand the research consent form.
- Ability to connect a tablet to the Internet.
Who cannot join
- Diagnosed with dementia such as AD, ischemic vascular dementia, normal pressure hydrocephalus, or Parkinson's disease.
- Schizophrenia, or other major psychiatric disorder defined by DSM-IV criteria.
- Medications: (a) Frequent use of high doses of analgesics; Use of sedative medications except for those used occasionally for sleep (≤2 per week); (b) Use of unstable dosing of Cholinesterase inhibitors (need to be stable dosing for 2 months); (c) AD disease modifying monoclonal antibody treatment e.g., aducanumab or lecanemab (completed the treatment is allowed)
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
Massachusetts General Hospital
Boston, Massachusetts, 02129
Catherine Young, 617-724-2428, cyoung@mgh.harvard.edu
Junyuan Hong, PhD, 517-668-5790, mr.junyuan.hong@gmail.com
About this study
Official title: AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults Based on the Efficacy-Proven I-CONECT Study
This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.
Read the detailed description
Social isolation is a well-established and modifiable risk factor for cognitive decline and dementia. The completed I-CONECT trial (NCT02871921) showed that frequent, one-to-one, semi-structured conversational engagement delivered remotely by trained human interviewers improved cognitive outcomes among socially isolated older adults with mild cognitive impairment. Two limitations have constrained translating that approach into a scalable preventive intervention: its reliance on trained human interviewers limits scalability, and the behavioral mechanisms responsible for its cognitive benefits remain incompletely understood.
AI-CONECT addresses both limitations by delivering the conversational intervention through a conversational artificial intelligence (AI) voice chatbot rather than a human interviewer, and by testing a hypothesized behavioral mechanism: that the intervention increases participants' social self-efficacy (confidence in their ability to engage socially), which in turn increases real-world social engagement.
- Conditions
- Mild Cognitive Impairment (MCI), Social Isolation
- Being tested
- AI-based conversational intervention
- Keywords
- Social Isolation, Artificial Intelligence, AI-Chatbot, I-CONECT, Mild Cognitive Impairment (MCI)
- Medical subject headings
- Cognitive Dysfunction, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based conversational interventionBehavioural
AI-based one-on-one semi-structured conversation for cognitive stimulation
| Study group | Role | What they receive |
|---|---|---|
| AI-CONECT | Experimental | Participants will receive four 15- to 30-minute conversations per week with the AI agent and a weekly 10- to15-minute survey call with a human interviewer. Receives: Behavioral: AI-based conversational intervention |
| Control | No intervention | Participants will receive a weekly 10- to 15-minute survey call with a human interviewer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Self-Efficacy
Participants' self-efficacy on social interactions using an instrument adapted from the Exercise Self-Efficacy Scale (EXSE, by McAuley, 1993). The scale comprises three items of confidence: interacting with others regularly, engaging with others when feeling less connected, and engaging others in conversations. The three items are adapted to social interaction in person and using technology (e.g., video calls), respectively. Each item is rated from 0 (not at all confident) to 10 (completely confident). A mean score is computed across the six items (range 0-10), with higher scores indicating greater social self-efficacy.
Measured: From enrollment to the end of intervention at 8 weeks
Time contacting friends or family
Change in weekly time contacting friends or family.
Measured: From enrollment to the end of the intervention at 8 weeks, using weekly data
Secondary outcomes (2)
Time out of home
Self-reported weekly time out of home (a proximate measure of social engagement by the participants), using weekly data.
Measured: From enrollment to the end of treatment at 8 weeks
Frequency of contacting friends
Self-reported frequency of contacting friends, using weekly data.
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Sep 2028 (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 Massachusetts General HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Hiroko Hayama Dodge, Massachusetts General Hospital
- Investigators
- Hiroko H Dodge, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701668
- Sponsor's protocol ID
- 2026P000461
- Acronym
- AI-CONECT
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified transcriptions and other collected data may be shared with external researchers under a Data Use Agreement (DUA). Shareable data may include outcome scores, adherence rates, chatbot-usage metrics, full conversational transcripts (after removal of any incidentally disclosed identifiable information), and audio recordings of sessions. Because raw audio recordings may be inherently identifiable, they will be shared only under a DUA. These data may also be made available to the NIH/NIA Program Official upon request. Data are stored on HIPAA-compliant servers (e.g., MGB Business Dropbox and MGB Azure) and encrypted drives. The participant linkage key is kept within Mass General Brigham. No individual-level data are deposited in public or controlled-access repositories under the current protocol; future repository sharing would require additional IRB review and approval.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults Based on the Efficacy-Proven I-CONECT Study
- ClinicalTrials.gov ID
- NCT07701668
- Acronym / sponsor ID
- AI-CONECT / 2026P000461
- Conditions
- Mild Cognitive Impairment (MCI), Social Isolation
- Keywords
- Social Isolation, Artificial Intelligence, AI-Chatbot, I-CONECT, Mild Cognitive Impairment (MCI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 14 Jul 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.
This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.
Detailed description
Social isolation is a well-established and modifiable risk factor for cognitive decline and dementia. The completed I-CONECT trial (NCT02871921) showed that frequent, one-to-one, semi-structured conversational engagement delivered remotely by trained human interviewers improved cognitive outcomes among socially isolated older adults with mild cognitive impairment. Two limitations have constrained translating that approach into a scalable preventive intervention: its reliance on trained human interviewers limits scalability, and the behavioral mechanisms responsible for its cognitive benefits remain incompletely understood.
AI-CONECT addresses both limitations by delivering the conversational intervention through a conversational artificial intelligence (AI) voice chatbot rather than a human interviewer, and by testing a hypothesized behavioral mechanism: that the intervention increases participants' social self-efficacy (confidence in their ability to engage socially), which in turn increases real-world social engagement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-CONECT | Experimental | Behavioral: AI-based conversational interventionParticipants will receive four 15- to 30-minute conversations per week with the AI agent and a weekly 10- to15-minute survey call with a human interviewer. |
| Control | No intervention | –Participants will receive a weekly 10- to 15-minute survey call with a human interviewer. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Aged 75+
- Clinical diagnosis of MCI (any subtype) or, when a clinical diagnosis is unavailable, a Telephone-MoCA (T-MoCA) score of 15-17.
- Identified as socially isolated, defined as meeting both of the following self-reported criteria: (a) lives alone in one's own residence, and (b) engages in conversations lasting 30 minutes or longer no more than twice per week.
- GDS-15 (15-item Geriatric Depression Scale) at/below 9 (not severely depressed).
- Social self-efficacy mean ≤ 8 (on the 0-10 scale) across the 6-item Social Self-Efficacy Scale at screening, indicating low confidence in social interaction.
Key exclusion criteria (3 listed)
- Diagnosed with dementia such as AD, ischemic vascular dementia, normal pressure hydrocephalus, or Parkinson's disease.
- Schizophrenia, or other major psychiatric disorder defined by DSM-IV criteria.
- Medications: (a) Frequent use of high doses of analgesics; Use of sedative medications except for those used occasionally for sleep (≤2 per week); (b) Use of unstable dosing of Cholinesterase inhibitors (need to be stable dosing for 2 months); (c) AD disease modifying monoclonal antibody treatment e.g., aducanumab or lecanemab (completed the treatment is allowed)
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-based conversational interventionAI-based one-on-one semi-structured conversation for cognitive stimulation | Behavioural | AI-CONECT |
Primary outcome
Social Self-Efficacy
Time frame: From enrollment to the end of intervention at 8 weeks
Participants' self-efficacy on social interactions using an instrument adapted from the Exercise Self-Efficacy Scale (EXSE, by McAuley, 1993). The scale comprises three items of confidence: interacting with others regularly, engaging with others when feeling less connected, and engaging others in conversations. The three items are adapted to social interaction in person and using technology (e.g., video calls), respectively. Each item is rated from 0 (not at all confident) to 10 (completely confident). A mean score is computed across the six items (range 0-10), with higher scores indicating greater social self-efficacy.
Time contacting friends or family
Time frame: From enrollment to the end of the intervention at 8 weeks, using weekly data
Change in weekly time contacting friends or family.
2 secondary outcomes
Time out of home
Time frame: From enrollment to the end of treatment at 8 weeks
Frequency of contacting friends
Time frame: From enrollment to the end of treatment at 8 weeks
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified transcriptions and other collected data may be shared with external researchers under a Data Use Agreement (DUA). Shareable data may include outcome scores, adherence rates, chatbot-usage metrics, full conversational transcripts (after removal of any incidentally disclosed identifiable information), and audio recordings of sessions. Because raw audio recordings may be inherently identifiable, they will be shared only under a DUA. These data may also be made available to the NIH/NIA Program Official upon request. Data are stored on HIPAA-compliant servers (e.g., MGB Business Dropbox and MGB Azure) and encrypted drives. The participant linkage key is kept within Mass General Brigham. No individual-level data are deposited in public or controlled-access repositories under the current protocol; future repository sharing would require additional IRB review and approval.
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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.
Hiroko H Dodge, PhD principal investigator
Massachusetts General Hospital
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-based conversational intervention in people with Mild Cognitive Impairment (MCI) and Social Isolation, run by Massachusetts General Hospital 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 7 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: opening soon, as of the sponsor's last update on 25 Aug 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?
Contact Catherine Young (617-724-2428, cyoung@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social Self-Efficacy (time frame: From enrollment to the end of intervention at 8 weeks). The study lists 2 primary outcomes in all. 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 25 Aug 2026.