Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-27 @ 7:50 AM
Study NCT ID:
NCT04926259
Status:
UNKNOWN
Last Update Posted:
2021-11-26
First Post:
2021-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-23', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-12', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'standardized uptake value ratio (SUVR)', 'timeFrame': 'From right after tracer injection to 2-hours post-injection', 'description': 'the ratio of radioactivity in a cerebral region to that in the cerebellum as a reference'}, {'measure': 'Aβ42 in CSF', 'timeFrame': 'Within 2 hours prior to tracer injection', 'description': 'Aβ42 (amyloid beta isoform 42) is significantly lower in the cerebrospinal fluid of patients with neurodegenerative diseases and is one of the biomarkers used clinically to diagnose neurodegenerative diseases'}, {'measure': 't-tau in CSF', 'timeFrame': 'Within 2 hours prior to tracer injection', 'description': 't-tau (total tau) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration'}, {'measure': 'p-tau in CSF', 'timeFrame': 'Within 2 hours prior to tracer injection', 'description': 'p-tau (tau phosphorylated at Thr-181) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration'}, {'measure': 'NfL in CSF', 'timeFrame': 'Within 2 hours prior to tracer injection', 'description': 'NfL (neurofilament light chain) is significantly increased in the cerebrospinal fluid of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration'}, {'measure': 'NfL in the blood', 'timeFrame': 'Within 2 hours prior to tracer injection', 'description': 'NfL is significantly increased in the blood of patients with neurodegeneration and is one of the biomarkers used clinically to diagnose neurodegeneration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neurodegenerative Disorders']}, 'descriptionModule': {'briefSummary': "Alzheimer's disease, Parkinson's disease, and Huntington's disease are common neurodegenerative diseases. Tau is a microtubule-associated protein, and aggregated tau resulting from hyperphosphorylation is a pathological feature of a group of neurodegenerative diseases known as tauopathies. The 18F-T807 (AV1451) molecular probe is a novel molecularly targeted imaging agent that exhibits high affinity and good selectivity for tau.", 'detailedDescription': 'In this study, 18F-T807 (AV1451) molecular probe PET/CT was used to monitor the regional distribution and the degree of deposition in patients with neurodegenerative diseases, and compared with clinical symptoms to evaluate its value in the early differential diagnosis of neurodegenerative diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients or their families complain of significant memory impairment;\n* Objective memory impairment (e.g., tests of article identification, recall, delayed memory);\n* Be able to obtain complete diagnosis and treatment records and be able to carry out long-term follow-up;\n* Signed written consent.\n\nExclusion Criteria:\n\n* Psychiatric disorders: including anxiety disorder, affective disorder, severe psychosis, or drug-induced psychosis;\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT04926259', 'briefTitle': 'Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Fujian Medical University'}, 'officialTitle': 'Tau PET Imaging With 18F-T807(AV1451) in Neurodegenerative Disorders', 'orgStudyIdInfo': {'id': 'MRCTA, ECFAH of FMU [2021]129'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-T807, PET/CT', 'description': 'PET/CT perform after injecting 18F-T807', 'interventionNames': ['Drug: 18F-T807']}], 'interventions': [{'name': '18F-T807', 'type': 'DRUG', 'description': 'Intravenous injection of one dose of 10mCi (370MBq, ±5%) 18F-T807. Each subject receive a single intravenous injection of 18F-T807, and undergo PET/CT imaging within the specificed time.', 'armGroupLabels': ['18F-T807, PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaobo Yao, PhD', 'role': 'CONTACT', 'email': 'yaoshaobo008@163.com', 'phone': '059187981618'}], 'facility': 'Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'centralContacts': [{'name': 'Shaobo Yao, PhD', 'role': 'CONTACT', 'email': 'yaoshaobo008@163.com', 'phone': '86-0591-87981618'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Fujian Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Nuclear Medicine Department', 'investigatorFullName': 'Shaobo Yao, PhD', 'investigatorAffiliation': 'First Affiliated Hospital of Fujian Medical University'}}}}