Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-07 @ 9:10 PM
Study NCT ID:
NCT04277767
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2020-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Ophthalmologic Tests and EEG Imaging in Alzheimer's Disease
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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-30', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-02-18', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OCT retinal and choroidal thickness', 'timeFrame': '2 days', 'description': 'retinal structural anatomy'}, {'measure': 'Retinal Photography vascular caliber', 'timeFrame': '2 days', 'description': 'use Retinal Photography to detect vascular caliber'}, {'measure': 'functional connection strength in the brain network', 'timeFrame': '7 days', 'description': 'record resting-state EEG, use graph theory to calculate the functional connection strength'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AD EEG OCT biomarker'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease (AD) is a prevalent, long-term progressive degenerative disorder with great social impact. It is currently thought that, in addition to neurodegeneration, vascular changes also play a role in the pathophysiology of the disease. Meantime, EEG resting state has also demonstrated significant change in patients with AD in neuroscience research area. Thus, the combination of these sensitive biomarkers would lead to a potential new biomarker for detection of AD, which has higher specificity and sensitivity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We would recruit three groups of elders. One is the control group without cognitive impairment, one is the aMCI group which is deemed as the pre-stage of AD, and also the AD group.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Alzheimer's Disease\n\nExclusion Criteria:\n\n* neurologic disorders\n* psychiatric disorders"}, 'identificationModule': {'nctId': 'NCT04277767', 'briefTitle': "The Role of Ophthalmologic Tests and EEG Imaging in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}, 'officialTitle': "The Combination of Ophthalmologic Tests and EEG Imaging as a New Biomarker for Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'AD2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild cognitive impairment (MCI)', 'description': 'observational', 'interventionNames': ['Diagnostic Test: observational']}, {'label': 'Patients with mild to moderate AD', 'description': 'observational', 'interventionNames': ['Diagnostic Test: observational']}, {'label': 'Normal controls', 'description': 'observational', 'interventionNames': ['Diagnostic Test: observational']}], 'interventions': [{'name': 'observational', 'type': 'DIAGNOSTIC_TEST', 'description': 'No intervention', 'armGroupLabels': ['Normal controls', 'Patients with mild to moderate AD', 'mild cognitive impairment (MCI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Li Gu, Dr.', 'role': 'CONTACT', 'email': 'guli7@mail2.sysu.edu.cn', 'phone': '15889937313', 'phoneExt': '+86'}, {'name': 'Jin yuan, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jin Yuan, phD', 'role': 'CONTACT', 'email': 'yuanjincornea@126.com', 'phone': '13825141659'}, {'name': 'Li Gu, phD', 'role': 'CONTACT', 'email': 'guli7@mail2.sysu.edu.cn', 'phone': '+8615889937313'}], 'overallOfficials': [{'name': 'Jin Yuan, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhongshan Ophthalmological Center, Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongshan Ophthalmic Center, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant dean', 'investigatorFullName': 'Jin Yuan', 'investigatorAffiliation': 'Zhongshan Ophthalmic Center, Sun Yat-sen University'}}}}