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NCT Number: NCT07130669

FACE Phase II (a Stage II Trial)

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.

Recruiting

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Key information

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Stanford University CogT Lab

Palo Alto, California, 94304-0000, United States

Location status: Recruiting

Location contact

Daniela Buchillon-Almeida

CONTACT

[email protected]

650-725-0581

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking
  • Aged 60-89
  • Living in a home, or independent- or assisted-living facility
  • Adequate visual and hearing acuity
  • Anti-depressants, antipsychotics, and/or anxiolytics have been stable for at least 7 days
  • Memory medications have been stable for at least 3 months
  • Absence of neurological/vascular disorder (For neurological disorders with minor symptoms check with PI on case-by-case basis)

Exclusion criteria

  • be enrolled in another intervention study aimed at improving cognition
  • live in nursing home
  • diagnosed with Multiple Sclerosis, TBI, chronic heart failure, Parkinson's disease, dementia

Treatment and study plan

Cognitive Remediation

Behavioral

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

Cognitive Remediation II

Behavioral

traditional computerized cognitive training

Other names: traditional computerized cognitive training

Primary outcomes

  1. multi-modal effective engagement index (AID)

    Time frame: up to 8 weeks, throughout the intervention sessions

    facial expression+ECG

Secondary outcomes

  1. the time spent on training

    Time frame: up to 8 weeks, throughout the intervention sessions

  2. self-report perceived fatigue

    Time frame: up to 8 weeks, throughout the intervention sessions

    likert scale, 6 items, summarized as 0-10 points

  3. memory

    Time frame: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13

    BVMT-R delayed recall t score

  4. executive function

    Time frame: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13

    EXAMINER composite score

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Vankee Lin, PhD

CONTACT

[email protected]

650-725-0581

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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