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NCT Number: NCT07701668

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

This randomized controlled trial examines the mechanisms of conversational AI-based interventions for early dementia prevention in socially isolated older adults.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

AI-based conversational intervention

Behavioral

AI-based one-on-one semi-structured conversation for cognitive stimulation

Primary outcomes

  1. 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.

  2. Time contacting friends or family

    Time frame: From enrollment to the end of intervention at 8 weeks

    Change in weekly time contacting friends or family.

Secondary outcomes

  1. Time out of home

    Time frame: From enrollment to the end of treatment at 8 weeks

    Self-reported weekly time out of home (a proximate measure of social engagement by the participants).

  2. Frequency of contacting friends

    Time frame: From enrollment to the end of treatment at 8 weeks

    Self-reported weekly frequency of contacting friends.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Young

CONTACT

[email protected]

617-724-2428

Junyuan Hong, PhD

CONTACT

[email protected]

517-668-5790

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

AI-CONECT: A Conversational AI for Early Dementia Prevention in Socially-Isolated Older Adults Based on the Efficacy-Proven I-CONECT Study

Acronym: AI-CONECT

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

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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