Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-02-23 @ 4:09 PM
Study NCT ID:
NCT02289118
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tau Imaging in Young Onset Dementia
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2014-11-05', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine and compare the similarities and differences in regional brain uptake of [18F]T807 by using standardized uptake value ratio (SUVr) in patients with typical AD, PCA and lvPPA', 'timeFrame': '2 years'}, {'measure': 'Correlate patterns of [18F]T807 binding based on standardized uptake value ratio (SUVr) with MRI-based regional volumetric (mm3) and cortical thickness (mm) measures', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Correlate CSF markers of amyloid (Aβ1-42) and/or tau (total tau, phospho-tau) pathology (pg/mL) to uptake of [18F]T807 based on standardized uptake value ratio (SUVr).', 'timeFrame': '2 years'}, {'measure': 'Correlate [18F]T807 binding based on standardized uptake value ratio (SUVr) with standard cognitive tests.', 'timeFrame': '2 years', 'description': 'Neurocognitive test results'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease, Early Onset", 'Logopenic Progressive Aphasia', 'Posterior Cortical Atrophy (PCA)']}, 'descriptionModule': {'briefSummary': "The central goal of this study is to determine and compare the similarities and differences in regional brain uptake of \\[18F\\]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). The investigators will correlate patterns of \\[18F\\]T807 binding with magnetic resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20 participants, 45-70 years old, with clinical evidence of young onset focal dementia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with early onset AD (symptoms preceding age 65)', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participants will be 45 - 70 years of age\n2. MMSE \\> 10 at screening visit.\n3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.\n4. Participants must be willing and able to comply with scheduled visits and imaging procedures.\n5. A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI either as a part of this study\n6. Participants must identify a study partner who is willing to accompany the patient to study visits\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast feeding at the time of screening scan will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening\n2. Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician\n3. QTc \\> 450 msec on screening ECG.\n4. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study (e.g. moderate to large stroke or history of moderate or severe traumatic brain injury (TBI))."}, 'identificationModule': {'nctId': 'NCT02289118', 'briefTitle': 'Tau Imaging in Young Onset Dementia', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': '[18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia', 'orgStudyIdInfo': {'id': '820665'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic Imaging', 'description': '\\[18F\\]T807 imaging tracer.', 'interventionNames': ['Drug: [18F]-T807 imaging tracer']}], 'interventions': [{'name': '[18F]-T807 imaging tracer', 'type': 'DRUG', 'otherNames': ['AV-1451'], 'description': 'Tau Imaging tracer', 'armGroupLabels': ['Diagnostic Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'David Wolk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}