NCT07130669 FACE Phase II (a Stage II Trial)
| NCT ID | NCT07130669 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Stanford University |
| Condition | MCI |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-10-31 |
| Primary Completion | 2028-05-31 |
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.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2025-10-31 with a primary completion date of 2028-05-31.
⚠ 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
How to ensure adherence to computerized cognitive training in unsupervised circumstances (e.g., at-home, self-administered) in older adults at risk for Alzheimer's disease (AD) or AD related dementia (AD/ADRD) is understudied. The objective of the R33 study is to test a novel facial expression-based personalization engine (FPE) for monitoring and modulating real-time effective engagement, with an ultimate goal of enhancing long-term adherence in unsupervised cognitive training in older adults at risk for AD/ADRD. Here, Effective engagement is defined as the extent to which someone is actively engaged and performing with significant attention and enjoyment while training, addressing a balance between adherence and cognitive gains/plasticity from the training. Based on previous work, the hypotheses include that (1) mental fatigue revealed in facial expressions will reflect a trainee's degree of effective engagement, which can be modified by modulating task novelty; (2) the proposed FPE will ensure the effective engagement in cognitive training by monitoring trainee facial expressions and modulating training in response, promoting the trainee's long-term adherence to the training and cognitive plasticity. A Stage II intervention efficacy study will be conducted to compare effective engagement and adherence in unsupervised cognitive training between training programs with vs. without FPE in older adults at risk for AD/ADRD. The proposed FPE may assist in monitoring and improving effective engagement and adherence in older adults with unsupervised cognitive training. In the current application, FPE in a cognitive training program called speed of processing training will be tested. However, such FPE may be embedded to any computerized cognitive training in future studies to help address adherence related issues.
Eligibility Criteria
Inclusion Criteria: 1. English speaking 2. Aged 60-89 3. Living in a home, or independent- or assisted-living facility 4. Adequate visual and hearing acuity 5. Anti-depressants, antipsychotics, and/or anxiolytics have been stable for at least 7 days 6. Memory medications have been stable for at least 3 months 7. Absence of neurological/vascular disorder (For neurological disorders with minor symptoms check with PI on case-by-case basis) Exclusion Criteria: 1. be enrolled in another intervention study aimed at improving cognition 2. live in nursing home 3. diagnosed with Multiple Sclerosis, TBI, chronic heart failure, Parkinson's disease, dementia
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07130669 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 89 Years, studying MCI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07130669 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07130669 currently recruiting?
Yes, NCT07130669 is actively recruiting participants. Contact the research team at CogTLab_Stanford@stanford.edu for enrollment information.
Where is the NCT07130669 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT07130669 clinical trial?
NCT07130669 is sponsored by Stanford University. The trial plans to enroll 80 participants.