FACE Phase II (a Stage II Trial)

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07130669
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • MCI
  • Mild Behavioral Impairment
  • Subjective Cognitive Decline (SCD)

Eligibility Criteria

Sex
ALL
Age
60 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 31, 2025
Status verified
Apr 2026
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: unsupervised cognitive training with personalized engine
    total 6 week intervention
  • Active Comparator: unsupervised cognitive training without personalized engine

Primary Outcome Measure

multi-modal effective engagement index (AID) [ Time Frame: up to 8 weeks, throughout the intervention sessions ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University CogT LabPalo AltoCalifornia94304-0000
Daniela Buchillon-Almeida
[email protected]
650-725-0581

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Stanford University CogT Lab· Palo Alto, CA

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