FACE Phase II (a Stage II Trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive Remediation, Cognitive Remediation II.
- Who it may be relevant to
- Registry conditions: MCI, Subjective Cognitive Decline (SCD), Mild Behavioral Impairment. Basic parameters: 60 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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)
Overview
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.
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
Primary outcome measures
- multi-modal effective engagement index (AID) [Time frame: up to 8 weeks, throughout the intervention sessions]
Secondary outcome measures (4)
- the time spent on training [Time frame: up to 8 weeks, throughout the intervention sessions]
- self-report perceived fatigue [Time frame: up to 8 weeks, throughout the intervention sessions]
- memory [Time frame: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13]
- executive function [Time frame: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Stanford University CogT Lab — Palo Alto
Identifiers
NCT: NCT07130669 · 82182