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

May 1, 2026 updated by: MALAZ BOUSTANI, Indiana University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nonpharmacological approaches, such as Reminiscence Therapy (RT), have been a major investigation for ADRD in recent years, but lack of human facilitators, lack of training, technology adaptation, and lack of multi-sensory features are major implementation barriers. In addition, a good RT requires utilizing the personal life experiences of patients as topics of sharing, while showing concrete objects such as photographs, videos, and music that are memorable to the individuals. However, older adults may have a hard time collecting these materials for themselves.

To address these limitations, the researchers have developed a novel SVR that is delivered through a computer program that can be accessed using a personal computer or smart device, and includes new functions so that there is no need for a human therapist to facilitate the RT sessions, and so that older adults and care partners do not need to collect reminiscence materials in advance. SVR presents a virtual therapist (avatar) who interacts with older adults through verbal (speech) and non-verbal communication (eye gaze, body language, etc.), understands the user's speech, and guides the user through reminiscence sessions.

In this study, patient/caregiver dyads will be randomized to receive SVR intervention or an attention control intervention (listening to music). Participants randomized to SVR will either visit the study site (accompanied by the caregiver) to complete SVR sessions or complete the sessions at home, up to twice a week for 12 weeks. Participants randomized to the control arm will receive a curated playlist of calming music, accessible online, that they need to listen to twice a week for 12 weeks. Patient BPSD will be collected at baseline and monthly for 3 months.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Katrina Coppedge, BA
  • Phone Number: 317-278-1602
  • Email: kcoppedg@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Sidney & Lois Eskenazi Hospital
        • Contact:
        • Principal Investigator:
          • Malaz Boustani, MD,MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

For the patient:

Inclusion criteria:

  • age ≥ 65 years
  • diagnosis of MCI (mild cognitive impairment) or mild ADRD
  • access to a reliable internet connection
  • community-dwelling
  • elevated behavioral and psychological symptoms of dementia (BPSD), indicated by a HABC (Healthy Aging Brain Care) monitor score above 14 on caregiver report or self report (indicating elevated levels of BPSD)
  • presence of one or more specific BPSD behaviors (e.g., agitation, anxiety, depression, apathy, or sleep disturbances)
  • ability to consent for themselves.

Exclusion criteria:

  • lives in an assisted living facility or nursing home
  • has moderate to severe ADRD as measured by the Quick Dementia Rating System
  • has a life expectancy of less than 6 months.

For the care partner:

Inclusion criteria:

  • ≥ 21 years old
  • self-identified care partner (e.g., is knowledgeable about the patient's daytime and nighttime behaviors) of a community-dwelling patient diagnosed with MCI or mild ADRD who will also participate in the study

Exclusion criteria:

  • has MCI or dementia
  • has a severe mental illness or substance abuse
  • has a life expectancy of less than 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patient Music Therapy
Patient listens to Youtube playlist
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).
Experimental: Smart Virtual Reminiscence Therapy
Patient uses Smart Virtual Reminiscence Therapy
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 Names:
  • SVR Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score
Time Frame: Baseline and Month 3
Caregivers assess multiple (12) behavior domains for the patient. For each behavior that is present, behavior frequency and severity are rated. Frequency is rated on a 4 point scale, with 1 indicating rare behavior and 4 indicating very frequent behavior. Severity is rated on a 3 point scale, with 1 indicating mild behavior and 3 indicating severe behavior. The product of frequency multiplied by severity equals the total domain score for each behavior. Total domain scores are then summed to obtain the NPI total score. NPI total scores can range from 0 to 144, with higher scores indicating more frequent and severe behaviors overall.
Baseline and Month 3
Rate of all-cause hospitalizations and emergency visits during the study period
Time Frame: Baseline through study completion, approximately 3 months
These data will be collected and used to assess whether a reduction in BPSD may lead to fewer crisis events requiring acute medical care.
Baseline through study completion, approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Malaz Boustani, MD, MPH, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Music Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe