Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-28 @ 6:02 PM
Study NCT ID:
NCT06924359
Status:
RECRUITING
Last Update Posted:
2025-04-11
First Post:
2025-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-06', 'studyFirstSubmitDate': '2025-04-06', 'studyFirstSubmitQcDate': '2025-04-06', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Multimodal Ophthalmic Imaging parameter values among groups', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Concentration difference of plasma biomarkers (Aβ42/40, p - tau181, p - tau217, NfL and GFAP） among groups', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer's Disease (AD)']}, 'descriptionModule': {'briefSummary': "With the accelerating global aging population, dementia has become a pressing worldwide issue. This project aims to identify specific plasma biomarkers and ocular indicators for the early detection of Alzheimer's disease (AD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'AD, MCI, SCD and CN', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female participants aged ≥ 50 years;\n* Participants diagnosed with Alzheimer's Disease (AD), mild cognitive decline (MCI), subjective cognitive decline (SCD), or cognitively normal (CN);\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Presence of other neurological disorders and systemic diseases that may cause cognitive impairment;\n* Inability to cooperate with cognitive assessments;\n* Refusal to undergo blood sampling."}, 'identificationModule': {'nctId': 'NCT06924359', 'acronym': 'MOIPAD', 'briefTitle': "Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': "Multimodal Ophthalmic Imaging and Plasma Biomarkers for the Early Detection of Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'AD-BIOPR-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Different stages of Alzheimer's disease", 'interventionNames': ['Diagnostic Test: Multimodal Ophthalmic Imaging and plasma biomarker']}], 'interventions': [{'name': 'Multimodal Ophthalmic Imaging and plasma biomarker', 'type': 'DIAGNOSTIC_TEST', 'description': 'Multimodal Ophthalmic Imaging and plasma biomarkers (Aβ42/40, p-tau181, p-tau217, NfL and GFAP）.', 'armGroupLabels': ["Different stages of Alzheimer's disease"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yong an Prof.Sun', 'role': 'CONTACT', 'email': 'sya@bjmu.edu.cn', 'phone': '83572371'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}