Tau Imaging in Professional Fighters

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.

Official Title
-----------------
18F-AV-1451 PET Imaging in Professional Fighters

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Flortaucipir F18
* Procedure: Brain PET scan


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Professional Fighters<br>Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan | Drug: Flortaucipir F18<br>* IV injection, 370 megabecquerel (MBq) (10 mCi)<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain 75-105 minutes post injection<br>|
| Experimental: Retired Professional Fighters<br>Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan | Drug: Flortaucipir F18<br>* IV injection, 370 megabecquerel (MBq) (10 mCi)<br>* Other names: Tauvid;Procedure: Brain PET scan<br>* positron emission tomography (PET) scan of the brain 75-105 minutes post injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flortaucipir Imaging (Quantitative) Between Cognitive Groups | 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. | baseline scan | 
| Flortaucipir Imaging (Quantitative) Between Fighter Groups | 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. | baseline scan | 
| Flortaucipir Imaging (Qualitative) Between Cognitive Groups | Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups. | baseline scan | 
| Flortaucipir Imaging (Qualitative) Between Fighter Groups | Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups | baseline scan |