NCT07499570 · RECRUITING
Multi-modal Large Language Model-Empowered Talk Therapy for Older Adults With ADRD
This trial is testing an AI-powered talk therapy tool called Smart Virtual Reminiscence therapy, which uses a virtual conversational agent to help older adults with MCI or mild dementia manage behavioral and psychological symptoms like anxiety, agitation, and depression. It is compared against music therapy. This is a Phase NA trial, meaning it is focused on feasibility and early effectiveness rather than a large-scale proof of efficacy.
Eligibility criteria
For the patient: Inclusion criteria: 1) age ≥ 65 years; 2) diagnosis of MCI (mild cognitive impairments) or mild ADRD; 3)Has access to a reliable internet connection 4) community-dwelling; 5) Elevated behavioral and psychological symptoms of dementia (BPSD), indicated by a HABC (Healthy Aging Brain Care) monitor above 14 on caregiver report or self report (indicating elevated levels of BPSD); 6) Presence of one or more specific BPSD behaviors (e.g., agitation, anxiety, depression, apathy, or sleep disturbances); 7) ability to consent for themselves. Exclusion criteria: 1) lives in an assisted living facility or nursing home - excluded to control for the potential confounding effect of a highly structured care environment, which could independently influence behavioral and psychological symptoms of dementia BPSD-; 2) have moderate to severe ADRD as measured by the Quick Dementia Rating System; 3) has a life expectancy of less than 6 months. For the care partner: Inclusion criteria: 1) ≥ 21 years old, 2) 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, and Exclusion criteria: 1) has MCI or dementia; and 2) has a severe mental illness or substance abuse; 3) has a life expectancy of less than 6 months.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-30