FACE Phase II (a Stage II Trial)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2028-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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MCI Subjective Cognitive Decline (SCD) Mild Behavioral Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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unsupervised cognitive training with personalized engine

total 6 week intervention

Group Type EXPERIMENTAL

Cognitive Remediation

Intervention Type BEHAVIORAL

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

unsupervised cognitive training without personalized engine

Group Type ACTIVE_COMPARATOR

Cognitive Remediation II

Intervention Type BEHAVIORAL

traditional computerized cognitive training

Interventions

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Cognitive Remediation

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

Intervention Type BEHAVIORAL

Cognitive Remediation II

traditional computerized cognitive training

Intervention Type BEHAVIORAL

Other Intervention Names

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traditional computerized cognitive training

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes