Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 10:44 AM
Study NCT ID:
NCT07130669
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FACE Phase II (a Stage II Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072466', 'term': 'Cognitive Remediation'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'multi-modal effective engagement index (AID)', 'timeFrame': 'up to 8 weeks, throughout the intervention sessions', 'description': 'facial expression+ECG'}], 'secondaryOutcomes': [{'measure': 'the time spent on training', 'timeFrame': 'up to 8 weeks, throughout the intervention sessions'}, {'measure': 'self-report perceived fatigue', 'timeFrame': 'up to 8 weeks, throughout the intervention sessions', 'description': 'likert scale, 6 items, summarized as 0-10 points'}, {'measure': 'memory', 'timeFrame': 'baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13', 'description': 'BVMT-R delayed recall t score'}, {'measure': 'executive function', 'timeFrame': 'baseline assessment at week 0, post-intervention assessment at week 7, followup assessment at week 13', 'description': 'EXAMINER composite score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['MCI', 'Subjective Cognitive Decline (SCD)', 'Mild Behavioral Impairment']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. English speaking\n2. Aged 60-89\n3. Living in a home, or independent- or assisted-living facility\n4. Adequate visual and hearing acuity\n5. Anti-depressants, antipsychotics, and/or anxiolytics have been stable for at least 7 days\n6. Memory medications have been stable for at least 3 months\n7. Absence of neurological/vascular disorder (For neurological disorders with minor symptoms check with PI on case-by-case basis)\n\nExclusion Criteria:\n\n1. be enrolled in another intervention study aimed at improving cognition\n2. live in nursing home\n3. diagnosed with Multiple Sclerosis, TBI, chronic heart failure, Parkinson's disease, dementia"}, 'identificationModule': {'nctId': 'NCT07130669', 'briefTitle': 'FACE Phase II (a Stage II Trial)', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '82182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'unsupervised cognitive training with personalized engine', 'description': 'total 6 week intervention', 'interventionNames': ['Behavioral: Cognitive Remediation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'unsupervised cognitive training without personalized engine', 'interventionNames': ['Behavioral: Cognitive Remediation II']}], 'interventions': [{'name': 'Cognitive Remediation', 'type': 'BEHAVIORAL', 'description': 'computerized cognitive training with a closed-loop human machine interface that monitor facial expression as engagement status of the person', 'armGroupLabels': ['unsupervised cognitive training with personalized engine']}, {'name': 'Cognitive Remediation II', 'type': 'BEHAVIORAL', 'otherNames': ['traditional computerized cognitive training'], 'description': 'traditional computerized cognitive training', 'armGroupLabels': ['unsupervised cognitive training without personalized engine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304-0000', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Oceanna Li', 'role': 'CONTACT', 'email': 'CogTLab_Stanford@stanford.edu', 'phone': '650-725-0581'}], 'facility': 'Stanford University CogT Lab', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'centralContacts': [{'name': 'Feng Vankee Lin, PhD', 'role': 'CONTACT', 'email': 'CogTLab_Stanford@stanford.edu', 'phone': '650-725-0581'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Feng Lin', 'investigatorAffiliation': 'Stanford University'}}}}