Recruiting
Phase 1
Phase 2

FPE & Cognitive Training

Sponsor:

Stanford University

Code:

NCT07130669

Conditions

MCI

Subjective Cognitive Decline (SCD)

Mild Behavioral Impairment

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Cognitive Remediation

Cognitive Remediation II

Study Details

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

Study ID

NCT07130669

Start date

Oct 31, 2025

Status verified date

Apr, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: unsupervised cognitive training with personalized engine

total 6 week intervention

active comparator: unsupervised cognitive training without personalized engine

Interventions

Cognitive Remediation

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

Cognitive Remediation II

traditional computerized cognitive training

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Stanford University CogT Lab

Recruiting

Palo Alto, California, United States, 94304-0000

Contacts

Daniela Buchillon-Almeida

650-725-0581dbuchill@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stanford University on 2026-04-24.