Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-26 @ 8:08 AM
Study NCT ID:
NCT05655650
Status:
RECRUITING
Last Update Posted:
2022-12-19
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Biomarkers in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma, blood cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-09', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The score change in Hong Kong List Learn Test (HKLLT)', 'timeFrame': 'Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit', 'description': 'The Hong Kong List Learn Test would be administered to assess the cognitive status for all group of study subjects'}, {'measure': 'The score change in Montreal Cognitive Assessment Hong Kong (HK-MoCA)', 'timeFrame': 'Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit', 'description': 'The Montreal Cognitive Assessment Hong Kong would be administered to assess the cognitive status for all group of study subjects'}, {'measure': 'The score change Clinical Dementia Rating (CDR)', 'timeFrame': 'Baseline, 1 year, 2 year, 3 year ,4 year ,5 year and 6 year visit after baseline visit', 'description': 'The Clinical Dementia Rating would be administered to assess the cognitive status for all group of study subjects'}, {'measure': 'Amount of amyloid β with 11C-Pittsburgh compound B', 'timeFrame': 'Baseline', 'description': 'Positron emission tomography imaging with 11C-Pittsburgh compound B would quantify the amount of amyloid β. Amyloid β is one of the biomarkers associate Alzheimer Disease'}, {'measure': 'Amount of amyloid tau with T807 tracer', 'timeFrame': 'Baseline', 'description': 'Positron emission tomography imaging with T807 tracer would quantify the amount of tau protein. tau protein is one of the biomarkers associate with Alzheimer Disease'}, {'measure': 'Amount of glucose hypometabolism', 'timeFrame': 'Baseline', 'description': 'Positron emission tomography imaging with 18F-FDG tracer would quantify the amount of glucose hypometabolism. glucose hypometabolism is one of the biomarkers associate with Alzheimer Disease'}, {'measure': 'arterial spin labeling magnetic resonance perfusion (ASL-MRP)', 'timeFrame': 'Baseline', 'description': 'Arterial spin labeling (ASL) perfusion is a MRI technique to quantify tissue blood flow of all group of subjects'}, {'measure': 'Change of Automatic Retinal Imaging', 'timeFrame': 'Baseline, 6th year follow up', 'description': 'There is a close anatomical correlation between both the macrovascular and the microvascular blood supply to the brain and the retina, and both vascular networks share similar vascular regulatory processes. Automatic Retinal Imaging is used to investigate microcirculations in retinal'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer Disease'], 'conditions': ['Neuro-Degenerative Disease', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease is a severe neurodegenerative disorder of the brain that is characterized by progressive loss of memory and cognitive decline. With the ageing population, AD is a major public health problem affecting nearly 35 million people worldwide with numbers projected to rise to 115.4 million by 2050. AD is the only cause of death among the top ten causes that has no prevention or cure . It is believed that novel treatment of AD needs to start early or even at the prodromal stage in order to be effective. Therefore, there is an urgent need to find accurate methods of early detection before patients with AD develop clinical dementia.\n\nThis study aims to identify biomarkers for AD in local Chinese population. this study hypothesizes blood-based proteomics, retinal imaging, ASL-MRP and tau PET can improve the accuracy and staging of AD.", 'detailedDescription': 'This is a cohort study. It involves baseline and 6 yearly follow ups. At baseline, all participants will go through a list of cognitive assessments, blood taking, Brain MRI scan, Brain PET scan and retinal imaging.\n\nAt the first five yearly follow ups, cognitive assessment will be performed. For the sixth yearly follow up, automatic retinal image will be performed in addition to cognitive assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AD subjects will be recruited from neurology cognitive disorder clinic of Prince of Wales Hospital. Age match normal control will be recruited from existing normal control studies.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chinese ethnicity\n* \\[For dementia group, clinical diagnosis of "probable Alzheimer\'s disease" according to recommendation from the National Institute on Aging-Alzheimer\'s Association workgroups (NIA-AA)\n\nExclusion Criteria:\n\n* Clinical diagnosis of non-AD dementia\n* contraindication for MRI or PET'}, 'identificationModule': {'nctId': 'NCT05655650', 'acronym': 'SEEDS', 'briefTitle': "Identifying Biomarkers in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': "Identifying Biomarkers in Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'SEEDS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal cognition', 'description': '75 subject without any of the following: subjective memory complaint and cognitive impairment base on cognitive assessments'}, {'label': 'Subjective Cognitive Disorder', 'description': '75 subjects without cognitive impairment based on cognitive cognitive assessments but with subject memory complaint'}, {'label': 'Mild Cognitive Impairment', 'description': '75 subjects with both subjective memory complaints and mild cognitive impairment base on cognitive assessments'}, {'label': 'Dementia', 'description': '75 subjects with both subjective memory complaints and moderate to severe cognitive impairment base on cognitive assessments'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'state': 'Hong Hong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Elyia Han, Bachelor', 'role': 'CONTACT', 'email': 'elyiahan@cuhk.edu.hk', 'phone': '+852 26975027'}, {'name': 'Vincent Mok, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Pualine Kwan', 'role': 'CONTACT', 'email': 'paulinekwan@cuhk.edu.hk', 'phone': '+852 26352160'}, {'name': 'Elyia Han', 'role': 'CONTACT', 'email': 'elyiahan@cuhk.edu.hk', 'phone': '+852 2697 5027'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vincent Mok', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}