Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT05479318
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Global Approach to Tackle Cognitive Decline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1502}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-07-26', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Record of any vascular risk factors', 'timeFrame': 'Baseline', 'description': 'medical history of hypertension, diabetes mellitus, hyperlipidemia, smoking and drinking, record unit as yes or no'}, {'measure': 'Record of triglyceride level', 'timeFrame': 'Baseline', 'description': 'triglyceride level, as one of vascular risk factors, unit as mmol/L'}, {'measure': 'Record of high-density-lipoprotein level,', 'timeFrame': 'Baseline', 'description': 'high-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L'}, {'measure': 'Record of low-density-lipoprotein level,', 'timeFrame': 'Baseline', 'description': 'low-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L'}, {'measure': 'Record of total cholesterol level,', 'timeFrame': 'Baseline', 'description': 'total cholesterol level, as one of the vascular risk factors, unit as mmol/L'}, {'measure': 'Record of glycated hemoglobin', 'timeFrame': 'Baseline', 'description': 'glycated hemoglobin, as one of the vascular risk factors, unit as percentage'}, {'measure': 'Record of fasting blood glucose', 'timeFrame': 'Baseline', 'description': 'fasting blood glucose from blood results, as one of vascular risk factors, unit as mmol/L'}, {'measure': 'Record of blood pressure', 'timeFrame': 'Baseline', 'description': 'Blood pressure, as one of vascular risk factors, unit as mmHg'}, {'measure': 'Record of pulse', 'timeFrame': 'Baseline', 'description': 'Pulse rate, as one of vascular risk factors, unit as bpm'}, {'measure': 'Change of Mini-Mental State Examination', 'timeFrame': 'Baseline and 3rd year follow up', 'description': 'Mini-Mental State Examination is used for measuring general cognition including the domains of attention and processing speed, executive function, memory, visuospatial function, and animal fluency.'}, {'measure': 'Change of Montreal Cognitive Assessment', 'timeFrame': 'Baseline, 1 yr, 2yr and 3rd year follow ups', 'description': 'Montreal Cognitive Assessment is used for measuring general cognition including the domains of attention and processing speed, executive function, memory, visuospatial function, and animal fluency.'}, {'measure': 'Changes of brain white matter abnormalities', 'timeFrame': 'Baseline and 1 yr, 2yr and 3rd year follow ups', 'description': 'brain white matter abnormalities can be observed through the FLAIR sequence of brain MRI images'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The number of people suffering from dementia in Asia (22.9 million) is more than twice the numbers in Europe (10.5 million) or the Americas (9.4 million), as recorded in the global impact of dementia in the World Alzheimer Report 2015.1 This dementia tsunami will continue to rise and the estimated number is 67 million in 2050 in Asia alone, which will be 2 to 3 times higher than the estimates for Europe (19 million) or the Americas (30 million). Devising and implementing preventive strategies against dementia is of paramount importance. The proposed project will be able to establish the associations between VRFs and cognition across cohorts with cultural, ethnical, and demographical variations. This study will generate data for evidence-based knowledge for globally implementable and effective preventive strategies for cognitive impairment and dementia.', 'detailedDescription': 'Participants will be retrospectively selected from a Hong Kong Chinese cohort, a Singaporean cohort, a British cohort, two European cohorts, and an Australian cohort.\n\nSubjects from the above listed cohorts who fit the study criteria will be selected for this study.\n\nDemographical information, clinical, vascular risk factors, MRI images and cognitive data will be retrieved from the cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be retrospectively selected from 7 cohorts from Hong Kong, Australia, Singapore and Europe areas.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elderly community-dwelling individuals aged over 60 years old;\n2. those with at least 2 time points of detailed cognitive measurements, with 2-3 years of assessment interval;\n3. with at least 1 timepoint of MRI (T1, FLAIR, and DTI).\n\nExclusion Criteria:\n\n1. subjects with stroke, dementia, and other neurological diseases at baseline;\n2. those without longitudinal cognitive data;\n3. those without MRI data available.'}, 'identificationModule': {'nctId': 'NCT05479318', 'briefTitle': 'A Global Approach to Tackle Cognitive Decline', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Global Approach to Tackle Cognitive Decline', 'orgStudyIdInfo': {'id': '2022.119'}}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Shatin', 'state': 'N.T.', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Bonnie Yin Ka Lam', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'The University of New South Wales', 'class': 'OTHER'}, {'name': 'University of Oxford', 'class': 'OTHER'}, {'name': 'University College, London', 'class': 'OTHER'}, {'name': 'Umeå University', 'class': 'OTHER'}, {'name': 'Max Planck Institute for Human Development', 'class': 'OTHER'}, {'name': 'National University of Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Bonnie Yin Ka LAM', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}