NCT04708613 · David Okonkwo, MD, PhD
University of Pittsburgh Brain Health Initiative
(BHI)
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Cognitive/Neuropsychological Testing
Comprehensive testing of cognitive function and brain health.
DIAGNOSTIC_TEST
Vestibular/Ocular-Motor Testing
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
DIAGNOSTIC_TEST
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.
DIAGNOSTIC_TEST
MRI, High-Resolution
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
DIAGNOSTIC_TEST
Health & Physical Exam
Participants will undergo an executive history and physical exam of all body systems.
DIAGNOSTIC_TEST
Physical Function
These assessments will involve a series of tests and questionnaires that focus on physical function.
DIAGNOSTIC_TEST
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,
DIAGNOSTIC_TEST
Applanation Tonometry
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
DIAGNOSTIC_TEST
PET brain imaging
PET imaging of the brain using tau and amyloid ligands.
DRUG
[C-11]6-OH-BTA-1
PET imaging of the brain using an amyloid ligand.
DRUG
[F-18]AV-1451
PET imaging of the brain using a tau ligand.
Primary outcome measures
Rates of Brain Health versus Cognitive Impairment
Time frame: 1-week
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
Where
- Pittsburgh, Pennsylvania
Collaborators
National Football League, Avid Radiopharmaceuticals, Inc., Harvard University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations