NCT07499570 Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD
| NCT ID | NCT07499570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-03 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Malaz Boustani, MD, MPH
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT07499570 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07499570 currently recruiting?
Yes, NCT07499570 is actively recruiting participants. Contact the research team at kcoppedg@iu.edu for enrollment information.
Where is the NCT07499570 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT07499570 clinical trial?
NCT07499570 is sponsored by Indiana University. The principal investigator is Malaz Boustani, MD, MPH at Indiana University. The trial plans to enroll 60 participants.