Menu
Not yet recruiting NCT07701668

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

No phase Interventional Mild Cognitive Impairment (MCI) Social Isolation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI-based conversational intervention.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI), Social Isolation. Basic parameters: from 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral AI-based conversational intervention
    AI-based one-on-one semi-structured conversation for cognitive stimulation

Primary outcome measures

  • Social Self-Efficacy [Time frame: From enrollment to the end of intervention at 8 weeks]
  • Time contacting friends or family [Time frame: From enrollment to the end of intervention at 8 weeks]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT07701668 · 2026P000461

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗