Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-30 @ 9:02 PM
Study NCT ID:
NCT06572332
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-14
First Post:
2024-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simulation-informed Modelling and Personalized Evaluation (SIMPLE) in Ageing Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-11', 'studyFirstSubmitDate': '2024-08-25', 'studyFirstSubmitQcDate': '2024-08-25', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated brain age', 'timeFrame': 'Baseline', 'description': "Using the structural and functional connectivity, individual's brain age is calculated based on the connectivity features of core brain networks."}, {'measure': 'Cognitive maintenance', 'timeFrame': 'Baseline', 'description': 'The dynamic change of cognitive status is used to evaluate cognitive maintenance. The performance of global cognition is used to determine the cognitive status, including mild neurocognitive disorder (NCD) and major NCD. The global cognition is measured by mini-mental state examination (MMSE).'}, {'measure': 'Plasma β-amyloid', 'timeFrame': 'Baseline', 'description': 'The levels of Aβ42 and Aβ40 in the plasma samples will be quantified by enzyme-linked immunosorbent assay.'}], 'secondaryOutcomes': [{'measure': 'Brain-predicted age difference (brain-PAD)', 'timeFrame': 'Baseline', 'description': 'The brain-PAD score is computed as the difference between estimated brain age and chronological age (brain age minus chronological age).'}, {'measure': 'Complex attention', 'timeFrame': 'Baseline', 'description': 'Attention network test (ANT) is an individually administered computerized task designed to evaluate three attentional components.'}, {'measure': 'Memory and learning', 'timeFrame': 'Baseline', 'description': 'Word list learning test consisting of fifteen semantically non-associated words that is presented consecutively over three trials of immediate recall and a 20-min delayed recall.'}, {'measure': 'Executive function', 'timeFrame': 'Baseline', 'description': 'Executive function is measured by the category verbal fluency test (CVFT).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Brain age', 'Deep learning', 'Healthy longevity', 'Resilence', 'Cognitive maintenance', 'Simulation', 'Imaging phenotypes'], 'conditions': ['Neurodegenerative Diseases', 'Aging', 'Brain', 'Cognitive Dysfunction']}, 'descriptionModule': {'briefSummary': "Multimodal magnetic resonance imaging (MRI), detecting brain structural and functional changes, has emerged as a powerful and promising technique to study individual's brain, as T1-weighted scans can detect morphometric features, diffusion tensor imaging (DTI) scans can quantify structural connectivity, and functional MRI can capture the features of functional connectivity. Notably, with the advances in quantitative methods, computational models of brain age and brain-predicted age difference (brain-PAD) detecting the ageing effects on individual's brain features are becoming increasingly popular in clinical studies, which might revolutionize the diagnostic and prognostic phonotypes of age-related brain diseases globally.", 'detailedDescription': "The score of brain-PAD has threefold explanations: a. negative score representing decelerated brain ageing (brain age\\<chronological age); b. positive score representing accelerated brain ageing (brain age\\>chronological age); c. score equal to zero, representing normal brain ageing (brain age=chronological age). The score of brain-PAD indicates the brain ageing pattern with the interaction of lifestyle and cognitive status at individual level. For example, based on structural MRI scans, a younger brain age or a negative score of brain-PAD was found to be associated with better cognition, which indicates the potential utilities of brain age matrices in predicting individual's cognitive maintenance and healthy longevity"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ageing adults and adults with sleep disturbances.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Chinese old adults are the ones who are over 60 years of chronological age.\n* Sleep disturbance: individual's subjective sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI) with a total score \\>5.\n\nExclusion Criteria:\n\n* History of bipolar disorders or psychosis.\n* History of major neurological deficits, including stroke, transient ischemic attack or brain tumor.\n* Unable to participant magnetic resonance imaging (MRI) scanning."}, 'identificationModule': {'nctId': 'NCT06572332', 'briefTitle': 'Simulation-informed Modelling and Personalized Evaluation (SIMPLE) in Ageing Populations', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Simulation-informed Modelling and Personalized Evaluation (SIMPLE): A Computational Study of MRI-based Brain Age Matrices', 'orgStudyIdInfo': {'id': '2023.171'}}, 'contactsLocationsModule': {'locations': [{'zip': '100000', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Tai Po Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Hanna Lu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'LU Hanna', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}