18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.

Official Title
-----------------
18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy

Conditions
-----------------
Chronic Traumatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: florbetapir F 18
* Drug: Flortaucipir F18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences of Repetitive Brain Injury in Athletes study protocols Can tolerate up to two PET imaging sessions Have the ability to provide informed consent for study procedures Exclusion Criteria: Claustrophobia Current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG History of risk factors for Torsades de Pointes or are taking drugs known to cause QT-prolongation Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer that the investigator believes would affect study participation or scan results Have had a non-study related radiopharmaceutical imaging or treatment within 7 days prior to study PET imaging sessions
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Risk of CTE<br>Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players) | Drug: florbetapir F 18<br>* 370 megabecquerel (MBq) IV single-dose<br>* Other names: 18F-AV-45;Drug: Flortaucipir F18<br>* 370 megabecquerel (MBq) IV single-dose<br>* Other names: LY3191748;|
| Experimental: Control<br>Flortaucipir PET scans in former non-contact athletes | Drug: florbetapir F 18<br>* 370 megabecquerel (MBq) IV single-dose<br>* Other names: 18F-AV-45;Drug: Flortaucipir F18<br>* 370 megabecquerel (MBq) IV single-dose<br>* Other names: LY3191748;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flortaucipir Visual Read as CTE Biomarker | Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'. | Baseline scan | 
| Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only) | The relationship between flortaucipir uptake and clinical presentation, as measured by the Mini-Mental State Examination (MMSE). Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. Specified in statistical analysis plan to only be conducted in High Risk of CTE group. | baseline scan |