NFL LONG Prospective Study

Summary

The purpose of this 5-year prospective research study is to characterize the association between concussions, sub-concussive exposure, and long-term neurologic health outcomes in former NFL players. To achieve the study aims, the investigators will conduct detailed research visits that include clinical outcome assessments, blood-based biomarkers, advanced magnetic resonance imaging (MRI), positron emission tomography (PET) using investigational tracers and genetic testing. Ultimately, the goal of this study is to translate the findings from this study into clinical, interventional studies for at risk former NFL players.

Conditions

• Concussion, Brain

Interventions

DRUG

[11C] PiB

Per study protocol static PET images will be acquired after IV infusion of CPiB to generate standard uptake values (SUVs). PET imaging is necessary in order to address the primary and secondary outcome measures as a component of neurological health (i.e., presence of proteinopathies empirically associated with neurodegenerative disease, cognitive decline, and neurological signs/symptoms). All groups will participate in this portion of the protocol.

DRUG

[18F] PBR111

Per study protocol static PET images will be acquired after IV infusion of F-PBR111 to generate standard uptake values (SUVs). PET imaging is necessary in order to address the primary and secondary outcome measures as a component of neurological health (i.e., presence of proteinopathies empirically associated with neurodegenerative disease, cognitive decline, and neurological signs/symptoms). All groups will participate in this portion of the protocol.

DRUG

[18F] Flortaucipir

Per study protocol static PET images will be acquired after IV infusion of F-T807 to generate standard uptake values (SUVs). PET imaging is necessary in order to address the primary and secondary outcome measures as a component of neurological health (i.e., presence of proteinopathies empirically associated with neurodegenerative disease, cognitive decline, and neurological signs/symptoms). All groups will participate in this portion of the protocol.

Sponsors & Collaborators

• Boston Children's Hospital

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• National Football League

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• William Meehan, MD · Boston Children's Hospital

• Michael McCrea, PhD · Medical College of Wisconsin

• Jason Mihalik, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

70 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-12

Primary Completion

2028-08-31

Completion

2028-08-31

FDA Drug

Yes

Countries

• United States

Study Locations