NCT07499570

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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). Smart Virtual Reminiscence (SVR) therapy uses a virtual interventionist and the Large Language Model technologies. 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.

Conditions

• MCI
• Dementia
• BPSD
• BPSD (Behavioral and Psycological Symptoms of Dementia)
• Reminiscence Therapy

Interventions

Type	Name	Description
DEVICE	Smart Virtual Reminiscence Therapy	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.
OTHER	Music Therapy	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).

Timeline

• Start date: 2025-09-03
• Primary completion: 2027-03-01
• Completion: 2027-06-30
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study