Clinical trial Recruiting at 1 site Interventional Ages 65 and up

BRAIN App program to support communication and engagement for people with dementia

Official title: The BRAIN App (Phase 2 SBIR): Building Relationships Using Artificial Intelligence and Nostalgia

Run by Hopeful Aging · NCT06298474 · Data updated 2026-11-12

This program tests whether the BRAIN App can improve communication, mood, and quality of life for people aged 65 and older with dementia living in long-term care, with training and support for family members and staff.

Quick facts

Study typeInterventional
Ages65 Years and up
SexAll
Enrollment120 (estimated)
SponsorHopeful Aging
Industry-sponsored
Locations1 site (Winchester, Massachusetts)
StatusRecruiting
StartedMay 15, 2025
Main results expectedNovember 30, 2026
Study endsNovember 30, 2026
Registry record updatedSeptember 15, 2026
Trial IDNCT06298474 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people aged 65 or older with a clinical diagnosis of dementia who can speak conversational English and live in one of the participating long-term care facilities.

Probably not a fit

Patients who are completely unable to communicate verbally, have serious uncorrected visual or hearing impairments, or show signs of rapid decline over the past three months are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project delivers a digital Cognitive Stimulation Therapy program via the BRAIN App to people living with dementia in nursing homes and assisted living facilities. A total of 120 residents (aged 65+) across eight long-term care sites will be split into experimental (n=60) and control (n=60) groups and measured before and after the intervention using a quasi-experimental pre-post design. Family members at experimental sites will use the app twice per month and staff will complete BRAIN training modules and use the platform to support sessions and report usability feedback. Key outcomes include resident quality of life, responsive behaviors, and relationship functioning between residents, professional care partners, and family members.

Why it matters

Potential benefit: If successful, the app could improve quality of life, reduce behavioral symptoms, and strengthen relationships between people living with dementia and their caregivers.

How similar studies have gone: Cognitive Stimulation Therapy has shown improvements in cognition and quality of life in prior trials, but delivering CST via a dedicated app is relatively novel though Phase I pilot work informed this Phase II effort.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 65+ years old
* Clinical diagnosis of dementia (any type)
* Able to speak conversational English

Exclusion Criteria:

* Completely unable to communicate verbally
* Serious visual or hearing impairments
* Signs of rapid decline over the last three months (based upon staff report)

Where it's running

  • Hopeful Aging
    Winchester, Massachusetts, United States
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.