AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults (AI-CONECT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mild Cognitive Impairment (MCI); Social Isolation
• Intervention / Treatment: Behavioral: AI-based conversational intervention

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Young; Phone Number: 617-724-2428; Email: cyoung@mgh.harvard.edu
• Study Contact Backup: Name: Junyuan Hong, PhD; Phone Number: 517-668-5790; Email: jhong28@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Massachusetts General Hospital
      • Contact: Catherine Young; Phone Number: 617-724-2428; Email: cyoung@mgh.harvard.edu
      • Contact: Junyuan Hong, PhD; Phone Number: 517-668-5790; Email: jhong28@mgh.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AI-CONECT; Participants will receive four 15-minute conversations per week with the AI agent and a weekly 15-minute survey call with a human interviewer.	Behavioral: AI-based conversational intervention; AI-based one-on-one semi-structured conversation for cognitive stimulation
No Intervention: Control; Participants will receive a weekly 15-minute survey call with a human interviewer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time out of home	Self-reported weekly time out of home (a proximate measure of social engagement by the participants).	From enrollment to the end of treatment at 8 weeks
Frequency of contacting friends	Self-reported weekly frequency of contacting friends.	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Hiroko H Dodge, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Social Isolation; Mild Cognitive Impairment (MCI); AI-Chatbot; I-CONECT
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Behavior; Social Behavior; Cognitive Dysfunction; Social Isolation
• Other Study ID Numbers: 2026P000461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No