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Completed

NCT Number: NCT02278354

Tau Imaging in Professional Fighters

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Flortaucipir F18

Drug

IV injection, 370 megabecquerel (MBq) (10 mCi)

Other names: [F-18]T807, 18F-AV-1451, LY3191748, Tauvid

Brain PET scan

Procedure

positron emission tomography (PET) scan of the brain 75-105 minutes post injection

Primary outcomes

  1. Flortaucipir Imaging (Quantitative) Between Cognitive Groups

    Time frame: baseline scan

    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.

  2. Flortaucipir Imaging (Quantitative) Between Fighter Groups

    Time frame: baseline scan

    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.

  3. Flortaucipir Imaging (Qualitative) Between Cognitive Groups

    Time frame: baseline scan

    Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.

  4. Flortaucipir Imaging (Qualitative) Between Fighter Groups

    Time frame: baseline scan

    Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Collaborators

  • The Cleveland Clinic

Registry information

Official study title

18F-AV-1451 PET Imaging in Professional Fighters

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2014
Registry last updated
Sep 10, 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.

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