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

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.

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Key information

Conditions

Chronic Traumatic Encephalopathy Brain Damage, Chronic Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Injury, Chronic Central Nervous System Diseases Chronic Disease Craniocerebral Trauma Disease Attributes Nervous System Diseases Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Banner Alzheimer's Institute, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

florbetapir F 18

Drug

370 megabecquerel (MBq) IV single-dose

Other names: Amyvid, 18F-AV-45

Flortaucipir F18

Drug

370 megabecquerel (MBq) IV single-dose

Other names: T807, 18F-AV-1451, LY3191748

Primary outcomes

Flortaucipir Visual Read as CTE Biomarker

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 6, 2014
Registry last updated: Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed