Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07499570

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Katrina Coppedge

CONTACT

[email protected]

317-278-1602

Malaz Boustani, MD,MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SVR Therapy

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).

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katrina Coppedge, BA

CONTACT

[email protected]

317-278-1602

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Acronym: SVR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.