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

Phase 2

Completed

• Conditions: Chronic Traumatic Encephalopathy
• Interventions: Drug: florbetapir F 18; Drug: Flortaucipir F18

• Registration Number: NCT02079766
• Lead Sponsor: Avid Radiopharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-06
• Study Start: 2014-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Disposition First Submitted: 2017-02-08
• Disposition First Submitted QC: 2017-02-08
• Disposition First Posted: 2017-02-09
• Results First Submitted: 2020-06-27
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-03
• Last Update Submitted: 2020-09-03
• Results First Posted: 2020-09-07
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Risk of CTE	florbetapir F 18	Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
Control	florbetapir F 18	Flortaucipir PET scans in former non-contact athletes
High Risk of CTE	Flortaucipir F18	Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
Control	Flortaucipir F18	Flortaucipir PET scans in former non-contact athletes

Primary Outcome Measures

Name	Time	Method
Flortaucipir Visual Read as CTE Biomarker	Baseline scan	Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.
Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)	baseline scan	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.

Trial Locations

Locations (2)

Banner Alzheimer's Institute; 🇺🇸 Phoenix, Arizona, United States

Boston University; 🇺🇸 Boston, Massachusetts, United States