MCIPhase 1/2NCT07130669
FACE Phase II (a Stage II Trial)
A Phase 1/2 study testing Cognitive Remediation and Cognitive Remediation II in people with MCI and Subjective Cognitive Decline (SCD), run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- MCI, Subjective Cognitive Decline (SCD), Mild Behavioral Impairment
- What is being tested?
- Cognitive Remediation and Cognitive Remediation II
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2025to 31 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University CogT Lab
Palo Alto, California, 94304-0000
Daniela Buchillon-Almeida, 650-725-0581, dbuchill@stanford.edu
About this study
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)
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.
- Being tested
- Cognitive Remediation, Cognitive Remediation II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive RemediationBehavioural
computerized cognitive training with a closed-loop human machine interface that monitor facial expression as engagement status of the person
Cognitive Remediation IIBehavioural
Also called traditional computerized cognitive training
traditional computerized cognitive training
| Study group | Role | What they receive |
|---|---|---|
| unsupervised cognitive training with personalized engine | Experimental | total 6 week intervention Receives: Behavioral: Cognitive Remediation |
| unsupervised cognitive training without personalized engine | Active comparator | Not described Receives: Behavioral: Cognitive Remediation II |
What is being measured
The primary outcome is the main question the study is designed to answer.
multi-modal effective engagement index (AID)
facial expression+ECG
Measured: up to 8 weeks, throughout the intervention sessions
Secondary outcomes (4)
the time spent on training
Measured: up to 8 weeks, throughout the intervention sessions
self-report perceived fatigue
likert scale, 6 items, summarized as 0-10 points
Measured: up to 8 weeks, throughout the intervention sessions
memory
BVMT-R delayed recall t score
Measured: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13
executive function
EXAMINER composite score
Measured: baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start31 Oct 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Lin, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130669
- Sponsor's protocol ID
- 82182
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07130669
- Acronym / sponsor ID
- 82182
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unsupervised cognitive training with personalized engine | Experimental | Behavioral: Cognitive Remediationtotal 6 week intervention |
| unsupervised cognitive training without personalized engine | Active comparator | Behavioral: Cognitive Remediation II |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediationcomputerized cognitive training with a closed-loop human machine interface that monitor facial expression as engagement status of the person | Behavioural | unsupervised cognitive training with personalized engine |
| Cognitive Remediation IIAlso: traditional computerized cognitive trainingtraditional computerized cognitive training | Behavioural | unsupervised cognitive training without personalized engine |
Primary outcome
multi-modal effective engagement index (AID)
Time frame: up to 8 weeks, throughout the intervention sessions
facial expression+ECG
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Remediation and Cognitive Remediation II in people with MCI and Subjective Cognitive Decline (SCD), run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Vankee Lin, PhD (650-725-0581, CogTLab_Stanford@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
multi-modal effective engagement index (AID) (time frame: up to 8 weeks, throughout the intervention sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.