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NOT YET RECRUITING
NCT07130669
PHASE1/PHASE2

FACE Phase II (a Stage II Trial)

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

Official title: A Facial Expression-based Personalization Engine (FPE) for Monitoring and Modulating Real-time Effective Engagement in Cognitive Training in Older Adults at Risk for AD/ADRD (CogT FACE Study Phase II)

Key Details

Gender

All

Age Range

60 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-10-31

Completion Date

2028-08-31

Last Updated

2025-08-19

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Cognitive Remediation

computerized cognitive training with a closed-loop human machine interface that monitor facial expression as engagement status of the person

BEHAVIORAL

Cognitive Remediation II

traditional computerized cognitive training

Locations (1)

Stanford University CogT Lab

Palo Alto, California, United States