Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-26 @ 5:02 AM
Study NCT ID:
NCT05058950
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22720}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "Study was terminated early as part of Biogen's ongoing research and development portfolio management efforts.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-19', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-17', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of the Classifier in Distinguishing Between Individuals With and Without MCI', 'timeFrame': 'Up to Month 23', 'description': 'A classifier is a mathematical function that uses collected data to calculate the probability that an individual belongs in a given category. The reference standard for the classifier is clinical diagnosis of MCI in normal clinical care or in a research cohort.'}, {'measure': 'Correlation Between the Cognitive Wellness Score and the Neuropsychological Testing Battery Score', 'timeFrame': 'Up to Month 23', 'description': 'To develop and validate a cognitive wellness score that tracks fluctuations in cognitive performance over time using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and Specificity of the Classifier in Predicting Between Individuals Who Do and Do Not Develop MCI', 'timeFrame': 'Up to Month 23', 'description': 'A classifier is a mathematical function that uses collected data to calculate the probability that an individual belongs in a given category. The reference standard for the classifier is clinical diagnosis of MCI in normal clinical care or in a research cohort.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment', 'Normal Aging']}, 'referencesModule': {'references': [{'pmid': '40038507', 'type': 'DERIVED', 'citation': 'Butler PM, Yang J, Brown R, Hobbs M, Becker A, Penalver-Andres J, Syz P, Muller S, Cosne G, Juraver A, Song HH, Saha-Chaudhuri P, Roggen D, Scotland A, Silveira N, Demircioglu G, Gabelle A, Hughes R, Erkkinen MG, Langbaum JB, Lingler JH, Price P, Quiroz YT, Sha SJ, Sliwinski M, Porsteinsson AP, Au R, Bianchi MT, Lenyoun H, Pham H, Patel M, Belachew S. Smartwatch- and smartphone-based remote assessment of brain health and detection of mild cognitive impairment. Nat Med. 2025 Mar;31(3):829-839. doi: 10.1038/s41591-024-03475-9. Epub 2025 Mar 4.'}], 'seeAlsoLinks': [{'url': 'https://www.intuitionstudy.com/', 'label': 'For additional information about the study: https://www.intuitionstudy.com/'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives are to develop and validate a classifier using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage to distinguish individuals with normal cognition from those with mild cognitive impairment (MCI) and to develop and validate a cognitive wellness score that tracks fluctuations in cognitive performance over time using multimodal passive sensor data and metrics derived from normal iPhone and Apple Watch usage.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '86 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population include participants with or without mild cognitive impairment.', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Fluent in spoken and written English\n* Minimum 8 years of education or 8th grade equivalent.\n* Willing to authorize the use of confidential health information in accordance with applicable privacy regulations.\n* Willing to wear an Apple Watch for daily use for the duration of the study.\n* Willing to use their personal iPhone for routine daily use for the duration of the study.\n* Technical requirements:\n\niPhone models: iPhone 8 or newer iOS versions: current publicly available iOS version\n\n* Access to one of the following personal computing devices. Microsoft Windows based personal computers (laptops and desktops) Mac personal computers (laptops and desktops) Apple iPad tablets\n* Access to WiFi or hardwired internet access in participant's place of residence.\n* Active email address for enrollment account creation and for use in relaying study information.\n* Active mobile telephone number for use in relaying study information when appropriate.\n* Primary address within the United States (50 states and Washington, DC; not a post office (PO) box).\n\nKey Exclusion Criteria:\n\n* Inability to comply with study requirements.\n* Any self-reported medical history of dementia (such as Alzheimer's disease, frontotemporal dementia, dementia with Lewy body, vascular dementia, rapidly progressive dementia, or Parkinson's disease dementia).\n* Self-reported dependence on others to perform core activities of daily living, including feeding, dressing, bathing, toileting, or grooming.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT05058950', 'acronym': 'Intuition', 'briefTitle': 'An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'An Observational Study Using Multimodal Sensors to Measure Cognitive Health in Adults and Distinguish Mild Cognitive Impairment From Normal Aging', 'orgStudyIdInfo': {'id': '285PI401'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Phenotyped in Research Objectively: Cognitively Normal', 'description': 'Participants with age ≥50 years and with a label of "cognitively normal" or its equivalent based on a clinical or research evaluation in the past 24 months will be enrolled virtually.'}, {'label': 'Phenotyped in Research Objectively: MCI', 'description': 'Participants with age ≥50 years, with a label of "MCI" or its equivalent based on a clinical or research evaluation in the past 24 months will be enrolled virtually.'}, {'label': 'Phenotyped in Research Objectively: Exploratory Biomarker', 'description': 'Participants with age ≥50 years, with documented positive result for an Alzheimer\'s disease biomarker, and with a label of "subjective cognitive complaints" or "cognitively normal" or its equivalent based on a clinical or research evaluation in the past 24 months will be enrolled virtually.'}, {'label': 'Aging Across Adulthood: MCI', 'description': 'Participants with age ≥50 years, with a diagnosis of MCI, mild neurocognitive disorder (MND), or cognitively impaired, not demented (CIND) will be enrolled virtually from the community.'}, {'label': 'Aging Across Adulthood: Subjective Cognitive Complaint', 'description': 'Participants with age ≥50 years and positive screen result from Cognitive Function Instrument (CFI) will be enrolled virtually from the community.'}, {'label': 'Aging Across Adulthood: Cognitively Normal With Risk Factor For Dementia', 'description': 'Participants with age ≥60 years and self-reported history of a minimum of 2-4 risk factors for cognitive decline will be enrolled virtually from the community.'}, {'label': 'Aging Across Adulthood: Cognitively Normal Without Risk Factors For Dementia', 'description': 'Participants with age ≥60 years having missing descriptor of minimal risk factors for cognitive decline will be enrolled virtually from the community.'}, {'label': 'Aging Across Adulthood: Cognitively Normal', 'description': 'Participants with age 21 to 59 years will be enrolled virtually from the community.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02142', 'city': 'Cambridge', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Virtual App-Based Study', 'geoPoint': {'lat': 42.3751, 'lon': -71.10561}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'ipdSharing': 'YES', 'description': "In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Apple Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}