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NCT04263337 · ClinicalTrials.gov registry record · Phase 1
NFL LONG Prospective Study
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Active
- Registry status
- Phase 1
- Development phase
- 250
- Enrollment target
NCT04263337: Active Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT04263337 is a Phase 1 study that is active but no longer recruiting, run by University of North Carolina, Chapel Hill. The registered enrollment target is 250 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (317% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04263337, a Phase 1 study, is active but no longer recruiting, sponsored by University of North Carolina, Chapel Hill.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 250 participants
- Enrollment target
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.
Primary Outcome
Positron Emission Tomography (PET) Scan- Standard uptake value ratio (SUVR) of the following tracers: Tau tracer, \[18 F\]Flortaucipir; AV1415 Amyloid tracer, Pittsburgh compound-B (11C-PiB); Neuroinflammation tracer, \[18 F\] peripheral benzodiazepine receptor (PBR111)
Interventions
- DRUG [11C] PiB
- DRUG [18F] PBR111
- DRUG [18F] Flortaucipir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
What the registry record for NCT04263337 still lists
NCT04263337 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (317% higher).
The record links to 0 conditions, and to 3 interventions - of which [11C] PiB is the first listed.
NCT04263337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04263337 about?
NCT04263337 is a clinical study titled "NFL LONG Prospective Study". 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 clini...
What is the current status of trial NCT04263337?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2020-03-12. Estimated completion is 2028-08.
What interventions are being tested in trial NCT04263337?
The interventions under investigation include: [11C] PiB (DRUG), [18F] PBR111 (DRUG), [18F] Flortaucipir (DRUG).
Who is sponsoring clinical trial NCT04263337?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04263337's enrollment target sits among peer trials
250 173rd of 2000 higher than 1,816 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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