Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-28 @ 2:58 PM
Study NCT ID:
NCT06918704
Status:
RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BID WM Digital Intervention in Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-14', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Working Memory', 'timeFrame': 'Immediately before the intervention, Immediately after the intervention, 6 months after the intervention', 'description': 'Working memory performance will be assessed with a delayed match-to-sample task.'}], 'secondaryOutcomes': [{'measure': 'Inhibitory Control', 'timeFrame': 'Immediately before the intervention, Immediately after the intervention, 6 months after the intervention', 'description': 'Inhibitory control will be assessed with the Stroop task.'}, {'measure': 'Inhibitory Control', 'timeFrame': 'Immediately before the intervention, Immediately after the intervention, 6 months after the intervention', 'description': 'Inhibitory control performance will be assessed by distractors within a delayed match-to-sample task.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognitive Training', 'Working Memory', 'Inhibitory Contorl'], 'conditions': ['Working Memory', 'Inhibitory Control']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if engaging with an digital intervention may improve cognitive function. The main questions it aims to answer are:\n\n1. Does engagement in with a digital intervention improve working memory?\n2. Does engagement in with a digital intervention improve inhibitory control?\n\nResearchers will compare two different digital interventions to assess whether they may be helpful in improving cognitive function.\n\nParticipants will conduct study activities remotely (e.g., at-home):\n\n1. Baseline Assessment. Complete a series of cognitive assessments and surveys.\n2. Intervention. Engage in a digital intervention for up to 8 weeks.\n3. Post Intervention Assessment. Complete the same cognitive assessments and surveys as the Baseline Assessment.\n4. Follow-Up Assessment. Six months after the intervention ends, participants will complete the same cognitive assessments and surveys as the Baseline Assessment.', 'detailedDescription': 'During the Baseline Assessment, participants will complete web-based cognitive assessments and surveys. The assessments will address various cognitive functions including working memory, long-term memory, inhibitory control, and sustained attention. Surveys will include a characterization of expectancy for the intervention, ratings of stress, and background health information. The Baseline Assessment will take up to 120 minutes and can be completed across more than one session.\n\nDuring the Intervention, participants will be provided an iPad tablet to engage with the assigned intervention app. Participants will be randomly assigned to one of two intervention apps. Regardless of the assigned intervention, participants will engage with the app for 25-45 minutes of training per day, 5 days a week for up to 8 weeks for a total of 1000 minutes of training.\n\nAfter the intervention, participants will complete a Post Intervention Assessment and 6 month later, a Follow-Up Assessment. Both of these assessment periods will consist of the same cognitive assessments and surveys as conducted during the Baseline Assessment.\n\nUpon completion of all study activities, participants will be able to keep the iPad as a gift for their voluntary participation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum of 12 years of education\n* English fluency\n* Normal or corrected-to-normal vision\n* Normal or corrected-to-normal vision\n* Medically healthy older adults including those with below-average cognitive performance or mild cognitive impairment patients without dementia\n\nExclusion Criteria:\n\n* Under the age of 60\n* Clinical diagnosis of neurological or psychiatric disorder\n* Visually or hearing impaired without correction to normal\n* Clinical diagnosis of dementia or AD8 score of \\>3\n* Regularly (one or more times per week) practicing an instrument within the last year\n* 10 or more years of formal musical instrument training'}, 'identificationModule': {'nctId': 'NCT06918704', 'briefTitle': 'BID WM Digital Intervention in Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Behavioral Intervention Development Core - Working Memory Digital Intervention in Aging', 'orgStudyIdInfo': {'id': '24-42925'}, 'secondaryIdInfos': [{'id': 'P30AG086635', 'link': 'https://reporter.nih.gov/quickSearch/P30AG086635', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coherence Intervention', 'description': 'Participants in this arm will engage with the Coherence Intervention.', 'interventionNames': ['Behavioral: Coherence']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Worder Intervention', 'description': 'Participants in this arm will engage with the Worder intervention.', 'interventionNames': ['Behavioral: Worder']}], 'interventions': [{'name': 'Coherence', 'type': 'BEHAVIORAL', 'description': 'Coherence is a music-based rhythm training app.', 'armGroupLabels': ['Coherence Intervention']}, {'name': 'Worder', 'type': 'BEHAVIORAL', 'description': 'Worder is a word search app.', 'armGroupLabels': ['Worder Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94621', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Melissa Arioli', 'role': 'CONTACT', 'email': 'Bid.Core@ucsf.edu', 'phone': '(415) 506-7321'}], 'overallOfficials': [{'name': 'Theodore Zanto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'De-identified data to be shared includes demographic, cognitive assessments, survey, and behavioral outcomes.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}