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| Name | Class |
|---|---|
| National Football League | OTHER |
| Avid Radiopharmaceuticals, Inc. | UNKNOWN |
| Harvard University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Former Professional Football Players | Former professional football players who played in at least 3 professional seasons, with at least 3 games each season. |
| |
| Control Groups | Friends and brothers of the Former Professional Football Player group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive/Neuropsychological Testing | Diagnostic Test | Comprehensive testing of cognitive function and brain health. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rates of Brain Health versus Cognitive Impairment | The diagnosis of cognitive impairment is based on the ADRC National Alzheimer's Coordinating Center (NACC) criteria for mild cognitive impairment. This criteria is adjudicated following a comprehensive neuropsychological exam, and includes: (1) Self- or informant-reported cognitive complaint, (2) Objective cognitive impairment, (3) Preserved independence in functional abilities, and (4) No dementia. | 1-week |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Syndromes of Neurodegeneration | The determination of trauma-related neurodegeneration will be based on: 1) presence of cognitive deficits, and/or neuromotor manifestations, and/or behavioral/mood-related symptoms; 2) PET scans demonstrating abnormal amyloid and/or tau deposition; 3) quantitative MR evidence of cortical volume loss and/or white matter injury; and 4) elevated CSF tau/Aβ42 ratio. These multiple measures will be combined to arrive at a single overall outcome measure. This will be adjudicated at a blinded Diagnostic Consensus Conference comprised of experts from each field. |
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Inclusion criteria:
Former professional football player/exposed group:
Control/unexposed group:
Exclusion criteria:
Control/unexposed group:
For both groups:
Females will not be included in the study population. Participants will be prior professional football players, age 29-59, that are eligible for a pension. Control participants will be group-matched for age and gender and therefore females will not be included in the study population.
Professional Football Players:
There will be 2 cohorts of former professional football players in this group: (a) random sample, and (b) non-random sample.
Random-Sample participants
Recruitment of random-sample former professional football players will be conducted via collaboration with the Football Players Health Study (FPHS) at Harvard University. Subjects for the Brain Health Initiative (BHI) will include a random sample of enrollees in the FPHS who meet basic eligibility for BHI.
Non-Random participants:
We will also enroll a non-random cohort of former professional football players that will be comprised of volunteers.
Controls:
There will be 3 cohorts of unexposed controls in this group: (a) friends of former players, (b) brothers or former players, and (c) general population. Football players will be invited to refer friend(s) and/or brother(s), but it is not required for participation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathryn L Edelman, MS | Contact | 412-624-1077 | dunfeekl@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| David O Okonkwo, MD, PhD | University of Pittsburgh Department of Neurological Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Department of Neurosurgery | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14568808 | Background | Lopez OL, Jagust WJ, DeKosky ST, Becker JT, Fitzpatrick A, Dulberg C, Breitner J, Lyketsos C, Jones B, Kawas C, Carlson M, Kuller LH. Prevalence and classification of mild cognitive impairment in the Cardiovascular Health Study Cognition Study: part 1. Arch Neurol. 2003 Oct;60(10):1385-9. doi: 10.1001/archneur.60.10.1385. | |
| 12904814 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 9, 2018 | Aug 4, 2023 |
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| Vestibular/Ocular-Motor Testing | Diagnostic Test | A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes. |
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| Sleep Evaluation | Diagnostic Test | 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. |
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| MRI, High-Resolution | Diagnostic Test | A high-resolution MRI to provide qualitative and quantitative assessments of brain structure. |
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| Health & Physical Exam | Diagnostic Test | Participants will undergo an executive history and physical exam of all body systems. |
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| Physical Function | Diagnostic Test | These assessments will involve a series of tests and questionnaires that focus on physical function. |
|
| Blood Testing and Biomarker Analysis | Diagnostic Test | 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. An optional lumbar puncture will be performed and CSF samples (20-30 mL) stored in the NCTC Biorepository until shipment to the CLIA-certified laboratory. Both CSF and blood samples will be analyzed for t-tau, p-tau, and Aβ42 and stored for future testing, |
|
| Applanation Tonometry | Diagnostic Test | Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer. |
|
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| PET brain imaging | Diagnostic Test | PET imaging of the brain using tau and amyloid ligands. |
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| [C-11]6-OH-BTA-1 | Drug | PET imaging of the brain using an amyloid ligand. |
|
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| [F-18]AV-1451 | Drug | PET imaging of the brain using a tau ligand. |
|
|
| 1-week |
| Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available. |
| SAP_000.pdf |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D010808 | Physical Examination |
| D006403 | Hematologic Tests |
| C507573 | (N-methyl-C-11)-2-(4-methylamino-phenyl)-6-hydroxybenzothiazole |
| C475519 | 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole |
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |
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