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

NCT07499570 | Recruiting FDA Device

• 1 other identifier: 28014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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). 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

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

Outcome Measures

Primary Outcomes (2)

• Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score

  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

  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

Study Arms (2)

Patient Music Therapy

ACTIVE COMPARATOR

Patient listens to Youtube playlist

Other: Music Therapy

Smart Virtual Reminiscence Therapy

EXPERIMENTAL

Patient uses Smart Virtual Reminiscence Therapy

Device: Smart Virtual Reminiscence Therapy

Interventions

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).

Patient Music Therapy

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.

Also known as: SVR Therapy

Smart Virtual Reminiscence Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Sidney & Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Behavior

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Malaz Boustani, MD, MPH

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrina Coppedge, BA

CONTACT

317-278-1602; kcoppedg@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: March 30, 2026
• Study Start: September 3, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

US (1)