University of Pittsburgh Brain Health Initiative

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.

Conditions

• Traumatic Brain Injury

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.

Sponsors & Collaborators

• National Football League Scientific Advisory Board

  collaborator UNKNOWN

• Avid Radiopharmaceuticals, Inc.

  collaborator UNKNOWN

• Harvard University

  collaborator OTHER

• David Okonkwo, MD, PhD

  lead OTHER

Principal Investigators

• David O Okonkwo, MD, PhD · University of Pittsburgh Department of Neurological Surgery

Eligibility

Min Age

29 Years

Max Age

59 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-18

Primary Completion

2026-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• United States

Study Locations