Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2019-11-18
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Cognitive/Neuropsychological Testing
Comprehensive testing of cognitive function and brain health.
Vestibular/Ocular-Motor Testing
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
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.
MRI, High-Resolution
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
Health & Physical Exam
Participants will undergo an executive history and physical exam of all body systems.
Physical Function
These assessments will involve a series of tests and questionnaires that focus on physical function.
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.
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
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
PET brain imaging
PET imaging of the brain using tau and amyloid ligands.
[C-11]6-OH-BTA-1
PET imaging of the brain using an amyloid ligand.
[F-18]AV-1451
PET imaging of the brain using a tau ligand.
Control Groups
Friends and brothers of the Former Professional Football Player group.
Cognitive/Neuropsychological Testing
Comprehensive testing of cognitive function and brain health.
Vestibular/Ocular-Motor Testing
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
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.
MRI, High-Resolution
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
Health & Physical Exam
Participants will undergo an executive history and physical exam of all body systems.
Physical Function
These assessments will involve a series of tests and questionnaires that focus on physical function.
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.
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
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
PET brain imaging
PET imaging of the brain using tau and amyloid ligands.
[C-11]6-OH-BTA-1
PET imaging of the brain using an amyloid ligand.
[F-18]AV-1451
PET imaging of the brain using a tau ligand.
Interventions
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Cognitive/Neuropsychological Testing
Comprehensive testing of cognitive function and brain health.
Vestibular/Ocular-Motor Testing
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
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.
MRI, High-Resolution
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
Health & Physical Exam
Participants will undergo an executive history and physical exam of all body systems.
Physical Function
These assessments will involve a series of tests and questionnaires that focus on physical function.
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.
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
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
PET brain imaging
PET imaging of the brain using tau and amyloid ligands.
[C-11]6-OH-BTA-1
PET imaging of the brain using an amyloid ligand.
[F-18]AV-1451
PET imaging of the brain using a tau ligand.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Professional football retiree aged 29-59
2. Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season
3. Fluent in English (translations are not available/validated for most neuropsychological tests)
Control/unexposed group:
1. Age 29-59 male
2. High school education or beyond
3. Fluent in English (translations are not available/validated for most neuropsychological tests)
Exclusion Criteria
1. Played organized football beyond high school
2. History of severe TBI
3. Current unstable cardiovascular disorder
For both groups:
1. Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.
2. Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia
29 Years
59 Years
MALE
Yes
Sponsors
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National Football League Scientific Advisory Board
UNKNOWN
Avid Radiopharmaceuticals, Inc.
UNKNOWN
Harvard University
OTHER
David Okonkwo, MD, PhD
OTHER
Responsible Party
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David Okonkwo, MD, PhD
Professor
Principal Investigators
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David O Okonkwo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Department of Neurological Surgery
Locations
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University of Pittsburgh Department of Neurosurgery
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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Brain Health Initiative
Identifier Type: -
Identifier Source: org_study_id
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