Brain Imaging for Concussion in Former NFL Players
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial investigates the long-term brain health of former NFL players who have experienced concussions. Researchers use advanced brain imaging techniques, including [11C] PiB, [18F] Flortaucipir, and [18F] PBR111, to understand how these injuries might affect cognitive functioning over time. The trial invites former NFL players who have retired and experienced concussions, as well as healthy males with no history of contact sports, to participate. The study aims to inform future treatments for those at risk of brain health issues due to sports-related concussions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking insights into brain health.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that [11C] PiB effectively images amyloid deposits in the brain, particularly in patients with traumatic brain injury (TBI). Researchers have used this tracer safely in various settings, with no significant side effects reported.
Research indicates that [18F] Flortaucipir is well-tolerated in older adults, including those with head injuries. This tracer helps detect tau protein build-up, linked to Alzheimer's disease and other conditions, without highlighting any major safety concerns.
For [18F] PBR111, specific data is limited. However, PET tracers like [18F] PBR111 are generally considered safe in medical imaging. As this trial is in its early phase, the primary goal is to assess the safety and tolerability of these tracers.
Overall, studies suggest that these imaging tracers are well-tolerated in humans, but the trial will further investigate their safety in former NFL players.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it uses advanced brain imaging techniques with [11C] PiB, [18F] Flortaucipir, and [18F] PBR111 to study concussions in former NFL players. Unlike traditional methods that rely heavily on cognitive testing and subjective assessments, these imaging agents can potentially provide a clearer picture of brain changes by highlighting abnormal protein deposits associated with concussion-related brain damage. This approach could lead to more precise diagnosis and better understanding of how repeated head injuries affect brain health over time, paving the way for targeted treatments in the future.
What evidence suggests that this trial's treatments could be effective for concussions in former NFL players?
In this trial, [11C] PiB, [18F] Flortaucipir, and [18F] PBR111 study brain changes in former NFL players with different cognitive functions and concussion histories. Research has shown that [11C] PiB effectively identifies amyloid deposits in the brain, linked to traumatic brain injuries (TBI). This compound adheres more to areas with amyloid build-up, aiding in detecting brain changes after concussions. Studies have found that [18F] Flortaucipir detects tau protein build-up in the brain, another marker often seen in brain injuries and conditions like chronic traumatic encephalopathy (CTE). Meanwhile, researchers have studied [18F] PBR111 as a method to track brain swelling after repeated head injuries. Together, these imaging agents provide important insights into brain changes related to concussions, helping researchers understand their long-term effects.14678
Who Is on the Research Team?
Michael McCrea, PhD
Principal Investigator
Medical College of Wisconsin
Jason Mihalik, PhD
Principal Investigator
University of North Carolina, Chapel Hill
William Meehan, MD
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This study is for former NFL players aged between 50-70 who have retired from professional football and have at least one year of NFL experience. It's also for individuals without prior exposure to football or other collision sports and concussions, matched by age and intellectual functioning to the player group.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
In-Person Neurobiopsychosocial Research Evaluation 1
Participants undergo a detailed neuropsychological assessment, patient-reported outcomes, and symptom validity measures, including proteomic and genomic studies, MRI, and PET imaging
Annual Follow-Up
Annual follow-up surveys of health status and life function are administered for 5 years
In-Person Neurobiopsychosocial Research Evaluation 2
A subset of participants return for a second research assessment of neurobiopsychosocial function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- [11C] PiB
- [18F] Flortaucipir
- [18F] PBR111
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Boston Children's Hospital
Collaborator
Medical College of Wisconsin
Collaborator
National Football League
Collaborator