Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 4:42 AM
Study NCT ID:
NCT03641768
Status:
WITHDRAWN
Last Update Posted:
2018-10-16
First Post:
2018-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], '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'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding not received', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2018-08-20', 'studyFirstSubmitQcDate': '2018-08-20', 'lastUpdatePostDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cortical thickness as measured by MRI scans', 'timeFrame': 'Baseline'}, {'measure': 'Beta amyloid plaques as measured by PET scans', 'timeFrame': 'Baseline'}, {'measure': 'Tau proteins as measured by PET scans', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Alzheimer Dementia', 'PTSD', 'MRI'], 'conditions': ['Alzheimer Dementia', 'Posttraumatic Stress Disorder', 'Traumatic Brain Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about how trauma, posttraumatic stress disorder (PTSD), and mild traumatic brain injury that can occur during deployment affect the brain. The investigators also want to learn how PTSD and mild traumatic brain injury can affect the chance of developing Alzheimer disease later in life. The investigators will study this by using magnetic resonance imaging and positron emission tomography scans to obtain pictures of the brain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 65\n* Previously enrolled in studies of OEF/OIF veterans by the same investigators\n* Free of implanted metal objects or mental shards in eyes\n* Fluent in English and capable of consenting\n\nExclusion Criteria:\n\n* Axis I disorders other than Major Depressive Disorder or PTSD\n* Current substance abuse or lifetime substance dependence (other than nicotine)\n* High risk for suicide\n* Claustrophobia\n* Neurological disorders\n* Learning disability or developmental delay\n* Major medical conditions'}, 'identificationModule': {'nctId': 'NCT03641768', 'briefTitle': 'Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics', 'orgStudyIdInfo': {'id': 'Pro00100030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteers', 'description': 'Volunteers with no trauma history', 'interventionNames': ['Device: MRI', 'Device: PET', 'Device: 18F-Florbetapir', 'Device: Radioligand 18F-AV-1451']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trauma only', 'description': 'Volunteers that do not have PTSD but have had similar trauma to those with PTSD', 'interventionNames': ['Device: MRI', 'Device: PET', 'Device: 18F-Florbetapir', 'Device: Radioligand 18F-AV-1451']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PTSD only', 'description': 'Volunteers with PTSD but no traumatic brain injury', 'interventionNames': ['Device: MRI', 'Device: PET', 'Device: 18F-Florbetapir', 'Device: Radioligand 18F-AV-1451']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PTSD and TBI', 'description': 'Volunteers with PTSD and mild traumatic brain injury', 'interventionNames': ['Device: MRI', 'Device: PET', 'Device: 18F-Florbetapir', 'Device: Radioligand 18F-AV-1451']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'You will be asked to undergo a scan of your brain called an MRI. The MRI scan can measure the functioning of your brain.', 'armGroupLabels': ['Healthy volunteers', 'PTSD and TBI', 'PTSD only', 'Trauma only']}, {'name': 'PET', 'type': 'DEVICE', 'description': 'You will be asked to undergo a scan of brain called a positron emission tomography (PET) scan. The PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how your brain is functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working.', 'armGroupLabels': ['Healthy volunteers', 'PTSD and TBI', 'PTSD only', 'Trauma only']}, {'name': '18F-Florbetapir', 'type': 'DEVICE', 'otherNames': ['PET tracer for Amyloid-beta'], 'description': 'At the Duke University PET Center you will be in a quiet dimly lit space with only ambient room sound, with your eyes open and ears unplugged. Your safety will be monitored by a physician and nurse. 18F-florbetapir will be administered to you as a bolus injection through a peripheral vein followed by a flush and 10 minute continuous brain PET imaging will begin 50 minutes post-injection.', 'armGroupLabels': ['Healthy volunteers', 'PTSD and TBI', 'PTSD only', 'Trauma only']}, {'name': 'Radioligand 18F-AV-1451', 'type': 'DEVICE', 'otherNames': ['PET tracer for Tau protein'], 'description': 'At the Duke University PET Center you will be in a quiet dimly lit space with only ambient room sound, with your eyes open and ears unplugged. Your safety will be monitored by a physician and nurse. 18F-florbetapir will be administered to you as a bolus injection through a peripheral vein followed by a flush and 10 minute continuous brain PET imaging will begin 50 minutes post-injection.', 'armGroupLabels': ['Healthy volunteers', 'PTSD and TBI', 'PTSD only', 'Trauma only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Rajendra Morey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}