FACE Phase II (a Stage II Trial) | NCT07130669

Studies
FACE Phase II (a Stage II Trial)

NCT07130669

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Apr 24, 2026Actual

Enrollment

80Estimated

Phase

Phase 1Phase 2

Conditions

MCI
Subjective Cognitive Decline (SCD)
Mild Behavioral Impairment

Interventions

Cognitive Remediation
Cognitive Remediation II

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2025Actual

Primary Completion Date

May 31, 2028Estimated

Completion Date

Aug 31, 2028Estimated

First Submitted Date

Aug 5, 2025

First Submission Date that Met QC Criteria

Aug 11, 2025

First Posted Date

Aug 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2026

Last Update Posted Date

Apr 24, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Feng Lin, Associate Professor, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
multi-modal effective engagement index (AID)	facial expression+ECG	up to 8 weeks, throughout the intervention sessions

Secondary Outcomes

Measure	Description	Time Frame
the time spent on training		up to 8 weeks, throughout the intervention sessions
self-report perceived fatigue	likert scale, 6 items, summarized as 0-10 points	up to 8 weeks, throughout the intervention sessions

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Feng Vankee Lin, PhD	Contact	650-725-0581		CogTLab_Stanford@stanford.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University CogT Lab	Recruiting	Palo Alto	California	94304-0000	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072466	Cognitive Remediation

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided