FACE Phase II (a Stage II Trial)

Not Applicable

Not yet recruiting

• Conditions: MCI; Subjective Cognitive Decline (SCD); Mild Behavioral Impairment

• Registration Number: NCT07130669
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-10-31
• Primary Completion: 2028-05-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
multi-modal effective engagement index (AID)	up to 8 weeks, throughout the intervention sessions	facial expression+ECG

Secondary Outcome Measures

Name	Time	Method
the time spent on training	up to 8 weeks, throughout the intervention sessions
self-report perceived fatigue	up to 8 weeks, throughout the intervention sessions	likert scale, 6 items, summarized as 0-10 points
memory	baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13	BVMT-R delayed recall t score
executive function	baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13	EXAMINER composite score

Trial Locations

Locations (1)

Stanford University CogT Lab; 🇺🇸 Palo Alto, California, United States