AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults
AI-CONECT
1 other identifier
interventional
80
1 country
1
Brief Summary
This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedStudy Start
First participant enrolled
July 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
July 14, 2026
July 1, 2026
1.6 years
February 19, 2026
July 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
From enrollment to the end of intervention at 8 weeks
Time contacting friends or family
Change in weekly time contacting friends or family.
From enrollment to the end of intervention at 8 weeks
Secondary Outcomes (2)
Time out of home
From enrollment to the end of treatment at 8 weeks
Frequency of contacting friends
From enrollment to the end of treatment at 8 weeks
Study Arms (2)
AI-CONECT
EXPERIMENTALParticipants will receive four 15-minute conversations per week with the AI agent and a weekly 15-minute survey call with a human interviewer.
Control
NO INTERVENTIONParticipants will receive a weekly 15-minute survey call with a human interviewer.
Interventions
AI-based one-on-one semi-structured conversation for cognitive stimulation
Eligibility Criteria
You may qualify if:
- Aged 75+
- Clinical diagnosis of MCI, or MMSE ≥ 24 or MoCA ≥ 18 (i.e., early MCI)
- Identified as socially isolated by at least one of the two criteria: (1)score ≤ 12 on the 6-item Lubben Social Network Scale (LSNS-6); (2) engages in conversations lasting 30 minutes or longer, no more than twice per week, per subject self-report
- 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.
You may not qualify if:
- 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: Frequent use of high doses of analgesics; Use of sedative medications except for those used occasionally for sleep (≤2 per week); Use of unstable dosing of Cholinesterase inhibitors (need to be stable dosing for 2 months).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02129, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hiroko H Dodge, PhD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 19, 2026
First Posted
July 14, 2026
Study Start
July 30, 2026
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
March 31, 2028
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- De-identified data and related materials are available upon request; the current protocol does not specify a fixed availability start or end date. Availability and retention follow Mass General Brigham and NIH record-retention requirements.
- Access Criteria
- Requests are reviewed by the study team. Sharing occurs only under an executed Data Use Agreement (DUA) or equivalent research agreement approved by the Mass General Brigham Contracting Office, is limited to de-identified or aggregated data for the analyses described in the protocol, and contractually prohibits re-identification and onward sharing. Data are transferred only via Mass General Brigham-approved secure, encrypted methods.
De-identified data will be shared with external researchers under a Data Use Agreement (DUA). The de-identified data may include datasets (outcome scores, adherence rates, chatbot-usage metrics), full conversational transcripts, and audio and video recordings of sessions; all are de-identified (direct identifiers removed) before sharing. De-identified data, analytic code, and summary reports are also available to the NIH/NIA Program Official on request. Data are stored on HIPAA-compliant servers (e.g., MGB Business Dropbox, MGB Azure) and encrypted drives. No identifiable data or Limited Data Sets are shared; 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.