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ENROLLING BY INVITATION
NCT04263337
PHASE1

NFL LONG Prospective Study

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

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.

Official title: Neurologic Function Across the Lifespan: A Prospective, LONGitudinal, and Translational Study for Former National Football League Players

Key Details

Gender

MALE

Age Range

50 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2020-03-12

Completion Date

2025-12

Last Updated

2025-06-19

Healthy Volunteers

Yes

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.

Locations (3)

Boston Children's Hospital

Waltham, Massachusetts, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States