Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:52 AM
Study NCT ID:
NCT07353502
Status:
RECRUITING
Last Update Posted:
2026-01-20
First Post:
2025-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
miR-342-5p/AnkG Pathway in Early AD Synaptic Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-18', 'studyFirstSubmitDate': '2025-09-17', 'studyFirstSubmitQcDate': '2026-01-18', 'lastUpdatePostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between miR-342-5p/AnkG Pathway and Synaptic Proteins', 'timeFrame': 'Within 12 weeks after enrollment', 'description': 'Quantitative Reverse Transcription-Polymerase Chain Reaction (QT-PCR) detection of microRNA-342-5p (miR-342-5p), Cytometric Bead Array (CBA) method detection of Ankyrin-G (AnkG), and Electrochemiluminescence (ECL) technology detection of neurogranin. Then analyze the correlation between miR-342-5p/AnkG and the synaptic protein neurogranin'}], 'secondaryOutcomes': [{'measure': 'The correlation between miR-342-5p/AnkG pathway and cognitive function and brain atrophy', 'timeFrame': 'Within 12 weeks after enrollment', 'description': 'miR-342-5p was detected by qRT-PCR, AnkG was measured by CBA method, cognitive function was evaluated using neuropsychological scales, and hippocampal atrophy was assessed by structural MRI.Then analyze the correlation between miR-342-5p/AnkG and cognitive function and hippocampal atrophy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Biomarker in Early Diagnosis']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease is the most common memory loss disease among the elderly. This disease affects the patient's memory, language, attention, and behavioral abilities. Current research has found that in the early stages of the disease, synaptic connections between brain nerve cells become abnormal, but the specific cause is still unclear. Investigators' previous research discovered that in the brains of diseased mice, certain special substances (the miR 342 5p/AnkG-mediated pathway) might be related to this abnormality, and these substances can be detected in both blood and cerebrospinal fluid. Therefore, investigators want to further explore the specific mechanisms of abnormal nerve cell connections, seek biomarkers for early detection of the disease, and provide new ideas for early diagnosis in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria for AD group:\n\n1. Meet the diagnostic criteria for "probable AD dementia" established by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer\'s Disease and Related Disorders Association (NINCDS-ADRDA)\n2. MMSE score between 0-23 points, Clinical Dementia Rating (CDR) score ≥0.5 points, Hachinski Ischemic Score \\<4 points\n3. Brain MRI showing bilateral temporal lobe and hippocampal atrophy\n4. Age ≥50 years\n\nInclusion criteria for control group:\n\n1. Healthy subjects with age matched to the AD group\n2. Normal cognitive function and good activities of daily living\n3. No dementia patients among first-degree relatives\n4. Negative brain MRI and neurological examination\n\nExclusion Criteria:\n\n1. Dementia or cognitive impairment caused by other diseases\n2. History of substance abuse\n3. Progressive primary aphasia\n4. Previous traumatic brain injury\n5. Patients with comorbid depression, schizophrenia, or severe diseases of the cardiovascular, hepatic, renal, or hematological systems\n6. Impaired consciousness and inability to cooperate\n7. Other conditions unsuitable for inclusion'}, 'identificationModule': {'nctId': 'NCT07353502', 'briefTitle': 'miR-342-5p/AnkG Pathway in Early AD Synaptic Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine'}, 'officialTitle': "Effects of miR-342-5p/AnkG Pathway-Mediated Axon Initial Segment Filtering Injury on Early Synaptic Dysfunction in Alzheimer's Disease and Its Clinical Applications", 'orgStudyIdInfo': {'id': 'KY-2025-070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AD Group', 'description': "Alzheimer's disease patients, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid.", 'interventionNames': ['Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.']}, {'type': 'OTHER', 'label': 'Healthy control group', 'description': 'Healthy control, collect peripheral blood, and if the patient agrees, also collect cerebrospinal fluid.', 'interventionNames': ['Other: Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.']}], 'interventions': [{'name': 'Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.', 'type': 'OTHER', 'description': 'Collect peripheral blood, and if the patient consents, also collect cerebrospinal fluid.', 'armGroupLabels': ['AD Group', 'Healthy control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '322000', 'city': 'Yiwu', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'xuhua xu', 'role': 'CONTACT'}], 'facility': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'Xu-hua Xu', 'role': 'CONTACT', 'email': 'fupinglangying@zju.edu.cn', 'phone': '+8613705790560'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Share after the paper is published, on the platform determined by the journal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}