18F-AV-1451 PET Imaging in Professional Fighters
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Flortaucipir Imaging (Quantitative) Between Fighter Groups
Study Overview
Brief Summary
Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to examine the relationship between clinical presentation and tau deposition.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All Subjects
- •Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
- •Can tolerate Positron Emission Tomography (PET) scan procedures
- •Have the ability to provide informed consent
- •Subjects with cognitive impairment
- •Have subjective cognitive complaints or objective decline or impairment as determined by the investigator
Exclusion Criteria
- •Have behavior dysfunction that is likely to interfere with imaging
- •Are claustrophobic or otherwise unable to tolerate the imaging procedure
- •Have current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
- •A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
- •Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- •Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
- •Have current drug or alcohol dependence or alcohol dependence within the past 2 years
Arms & Interventions
Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Intervention: Brain PET scan (Procedure)
Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Intervention: Brain PET scan (Procedure)
Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Intervention: Flortaucipir F18 (Drug)
Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Intervention: Flortaucipir F18 (Drug)
Outcomes
Primary Outcomes
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Time Frame: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Time Frame: baseline scan
Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Time Frame: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.
Flortaucipir Imaging (Qualitative) Between Fighter Groups
Time Frame: baseline scan
Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups
Secondary Outcomes
No secondary outcomes reported