Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD (NCT07499570) | Clinical Trial Compass
RecruitingNot Applicable
Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD
United States60 participantsStarted 2025-09-03
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in BPSD as measured by the Neuropsychiatric Inventory (NPI) total score
Timeframe: Baseline and Month 3
2
Rate of all-cause hospitalizations and emergency visits during the study period
Timeframe: Baseline through study completion, approximately 3 months