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

Avid Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Traumatic Encephalopathy

Treatments: Drug: Flortaucipir F18; Drug: florbetapir F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT02079766

18F-AV-1451-A07

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Male

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

High Risk of CTE

Experimental group

Description:

Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)

Treatment:

Drug: florbetapir F 18

Drug: Flortaucipir F18

Control

Experimental group

Description:

Flortaucipir PET scans in former non-contact athletes

Treatment:

Drug: florbetapir F 18

Drug: Flortaucipir F18