FACE Phase II (a Stage II Trial)

NCT07130669 | Recruiting Phase 1 DMC

• 1 other identifier: 82182
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• multi-modal effective engagement index (AID)

  facial expression+ECG

  up to 8 weeks, throughout the intervention sessions

Secondary Outcomes (4)

• 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

• memory

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

• executive function

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

Study Arms (2)

unsupervised cognitive training with personalized engine

EXPERIMENTAL

total 6 week intervention

Behavioral: Cognitive Remediation

unsupervised cognitive training without personalized engine

ACTIVE COMPARATOR

Behavioral: Cognitive Remediation II

Interventions

Cognitive Remediation BEHAVIORAL

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

unsupervised cognitive training with personalized engine

Cognitive Remediation II BEHAVIORAL

traditional computerized cognitive training

Also known as: traditional computerized cognitive training

unsupervised cognitive training without personalized engine

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University CogT Lab

Palo Alto, California, 94304-0000, United States

RECRUITING

MeSH Terms

Interventions

Cognitive Remediation

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Feng Vankee Lin, PhD

CONTACT

650-725-0581; CogTLab_Stanford@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 19, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)