University of Pittsburgh Brain Health Initiative
BHI
Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players
1 other identifier
observational
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 18, 2019
CompletedFirst Submitted
Initial submission to the registry
January 5, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 13, 2025
June 1, 2025
7 years
January 5, 2021
June 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Clinical Syndromes of Neurodegeneration
1-week
Study Arms (2)
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.
Interventions
Comprehensive testing of cognitive function and brain health.
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
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.
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
Participants will undergo an executive history and physical exam of all body systems.
These assessments will involve a series of tests and questionnaires that focus on physical function.
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,
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
PET imaging of the brain using tau and amyloid ligands.
PET imaging of the brain using an amyloid ligand.
PET imaging of the brain using a tau ligand.
Eligibility Criteria
1. Professional Football Players: There will be 2 cohorts of former professional football players in this group: (a) random sample, and (b) non-random sample. 1. 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. 2. Non-Random participants: We will also enroll a non-random cohort of former professional football players that will be comprised of volunteers. 2. 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.
You may qualify if:
- Former professional football player/exposed group:
- Professional football retiree aged 29-59
- Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season
- Fluent in English (translations are not available/validated for most neuropsychological tests)
- Control/unexposed group:
- Age 29-59 male
- High school education or beyond
- Fluent in English (translations are not available/validated for most neuropsychological tests)
You may not qualify if:
- Control/unexposed group:
- Played organized football beyond high school
- History of severe TBI
- Current unstable cardiovascular disorder
- For both groups:
- Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.
- Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- David Okonkwo, MD, PhDlead
- National Football League Scientific Advisory Boardcollaborator
- Avid Radiopharmaceuticals, Inc.collaborator
- Harvard Universitycollaborator
Study Sites (1)
University of Pittsburgh Department of Neurosurgery
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (2)
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.
PMID: 14568808BACKGROUNDPetersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available.
PMID: 12904814BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David O Okonkwo, MD, PhD
University of Pittsburgh Department of Neurological Surgery
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 5, 2021
First Posted
January 14, 2021
Study Start
November 18, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share