[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100416894":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":81,"centralContacts":86,"locations":92,"responsibleParty":123,"collaborators":127,"id":135,"slug":136,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":143,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":10,"studyType":150,"phases":10,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":95,"whyStopped":10,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Former Professional Football Players",null,"Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.",[13,14,15,16,17,18,19,20,21,22,23],"Diagnostic Test: Cognitive\u002FNeuropsychological Testing","Diagnostic Test: Vestibular\u002FOcular-Motor Testing","Diagnostic Test: Sleep Evaluation","Diagnostic Test: MRI, High-Resolution","Diagnostic Test: Health & Physical Exam","Diagnostic Test: Physical Function","Diagnostic Test: Blood Testing and Biomarker Analysis","Diagnostic Test: Applanation Tonometry","Diagnostic Test: PET brain imaging","Drug: [C-11]6-OH-BTA-1","Drug: [F-18]AV-1451",{"label":25,"type":10,"description":26,"interventionNames":27},"Control Groups","Friends and brothers of the Former Professional Football Player group.",[13,14,15,16,17,18,19,20,21,22,23],[29,34,38,42,46,50,54,58,64,68,75],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"DIAGNOSTIC_TEST","Cognitive\u002FNeuropsychological Testing","Comprehensive testing of cognitive function and brain health.",[25,9],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Vestibular\u002FOcular-Motor Testing","A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.",[25,9],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":10},"Sleep Evaluation","A full assessment of sleep health, including insomnia (duration, frequency, daytime consequences) and other sleep disorders such as obstructive sleep apnea. Overnight sleep study is included.",[25,9],{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":10},"MRI, High-Resolution","A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.",[25,9],{"type":30,"name":47,"description":48,"armGroupLabels":49,"otherNames":10},"Health & Physical Exam","Participants will undergo an executive history and physical exam of all body systems.",[25,9],{"type":30,"name":51,"description":52,"armGroupLabels":53,"otherNames":10},"Physical Function","These assessments will involve a series of tests and questionnaires that focus on physical function.",[25,9],{"type":30,"name":55,"description":56,"armGroupLabels":57,"otherNames":10},"Blood Testing and Biomarker Analysis","A blood draw will be performed to measure standard clinical labs as part of a full history and physical, as well as additional analysis of biomarkers indicative of brain health.\n\nAn optional lumbar puncture will be performed and CSF samples (20-30 mL) stored in the NCTC Biorepository until shipment to the CLIA-certified laboratory.\n\nBoth CSF and blood samples will be analyzed for t-tau, p-tau, and Aβ42 and stored for future testing,",[25,9],{"type":30,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Applanation Tonometry","Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.",[25,9],[63],"Continuous arterial pressure",{"type":30,"name":65,"description":66,"armGroupLabels":67,"otherNames":10},"PET brain imaging","PET imaging of the brain using tau and amyloid ligands.",[25,9],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"DRUG","[C-11]6-OH-BTA-1","PET imaging of the brain using an amyloid ligand.",[25,9],[74],"Pittsburgh Compound B",{"type":69,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"[F-18]AV-1451","PET imaging of the brain using a tau ligand.",[25,9],[80],"[F-18]T807, LY3191748",[82],{"name":83,"affiliation":84,"role":85},"David O Okonkwo, MD, PhD","University of Pittsburgh Department of Neurological Surgery","PRINCIPAL_INVESTIGATOR",[87],{"name":88,"role":89,"phone":90,"phoneExt":10,"email":91},"Kathryn L Edelman, MS","CONTACT","412-624-1077","dunfeekl@upmc.edu",[93],{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"University of Pittsburgh Department of Neurosurgery","RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-79.99589,40.44062,{"lat":105,"lon":104},[108,110,114,115,117,119,121],{"name":109,"role":89,"phone":90,"phoneExt":10,"email":91},"Kathryn Edelman, MS",{"name":111,"role":89,"phone":112,"phoneExt":10,"email":113},"Jane Sharpless, MS","412-648-2176","sharplessjm@upmc.edu",{"name":83,"role":85,"phone":10,"phoneExt":10,"email":10},{"name":116,"role":85,"phone":10,"phoneExt":10,"email":10},"James Mountz, MD, PhD",{"name":118,"role":85,"phone":10,"phoneExt":10,"email":10},"Michael Collins, PhD",{"name":120,"role":85,"phone":10,"phoneExt":10,"email":10},"Oscar Lopez, MD",{"name":122,"role":85,"phone":10,"phoneExt":10,"email":10},"Anthony Kontos, PhD",{"type":124,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","David Okonkwo, MD, PhD","Professor",[128,130,133],{"name":129,"class":6},"National Football League",{"name":131,"class":132},"Avid Radiopharmaceuticals, Inc.","UNKNOWN",{"name":134,"class":6},"Harvard University","100416894","university-of-pittsburgh-brain-health-initiative-100416894",false,"NCT04708613","University of Pittsburgh Brain Health Initiative","Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players","BHI","Inclusion criteria:\n\nFormer professional football player\u002Fexposed group:\n\n1. Professional football retiree aged 29-59\n2. Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season\n3. Fluent in English (translations are not available\u002Fvalidated for most neuropsychological tests)\n\nControl\u002Funexposed group:\n\n1. Age 29-59 male\n2. High school education or beyond\n3. Fluent in English (translations are not available\u002Fvalidated for most neuropsychological tests)\n\nExclusion criteria:\n\nControl\u002Funexposed group:\n\n1. Played organized football beyond high school\n2. History of severe TBI\n3. Current unstable cardiovascular disorder\n\nFor both groups:\n\n1. Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.\n2. Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia",true,"MALE","29 Years","59 Years",{"count":148,"type":149},300,"ESTIMATED","OBSERVATIONAL","This project will define the prevalence of brain health (i.e., normal cognitive, neuromotor, behavioral function) in living professional football retirees and group-matched controls through a comprehensive assessment of clinical, neuroimaging, and biomarker measures.",[153],"Traumatic Brain Injury",[155,156,157,158],"Brain Health","Football","Contact Sport","Concussion","2026-06-17",{"date":161,"type":162},"2026-06-22","ACTUAL",{"date":164,"type":162},"2019-11-18",{"date":166,"type":149},"2026-12",{"name":125,"class":6},1]