Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07499570
Status
Recruiting
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Conditions

  • BPSD
  • BPSD (Behavioral and Psychological Symptoms of Dementia)
  • Dementia
  • Mild Cognitive Impairment
  • Reminiscence Therapy

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Smart Virtual Reminiscence Therapy — DEVICE
    SVR Therapy is delivered through a computer program that can be accessed using a personal computer or smart device. It uses virtual reality, automated speech recognition, and large language models to achieve virtual therapist-patient interaction. The SVR therapy platform also automatically sources multi-modal reminiscence materials (e.g., images, text, etc.) through search engines and databases to facilitate the reminiscence therapy sessions. Each participant will participate in two 25-60 min (depending on content) sessions/week across 12 weeks. Each session will include multiple trials of reminiscence, such as music, sports, arts, etc. Each trial takes about 10 minutes to finish. The exact number of trials finished will depend on each patient's speed, preference, and how long they engage in the interaction with the SVR system. The participants can take breaks as needed.
  • Music Therapy — OTHER
    Participants in the attention control group will receive a curated playlist of calming music that they need to listen to twice a week for 12 weeks. The music can be conveniently accessed online (e.g., through YouTube).

Study Details

The purpose of this study is to test the usefulness and the effect of Smart Virtual Reminiscence (SVR) therapy intervention on the Behavioral and Psychological Symptoms of Dementia (BPSD) of patients with Alzheimer's Disease and Related Dementias (ADRD). SVR is designed to help older adults improve their psychological well-being and cognition. This research supports our long-term goal of designing and implementing intelligent interactive systems to improve the health of individuals with ADRD.

Key Dates

Start date
Sep 3, 2025
Status verified
May 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Patient Music Therapy
    Patient listens to Youtube playlist
  • Experimental: Smart Virtual Reminiscence Therapy
    Patient uses Smart Virtual Reminiscence Therapy

Primary Outcome Measure

Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score [ Time Frame: Baseline and Month 3 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney & Lois Eskenazi HospitalIndianapolisIndiana46202
Katrina Coppedge
[email protected]
317-278-1602
Malaz Boustani, MD,MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Sidney & Lois Eskenazi Hospital· Indianapolis, IN

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