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Tau Imaging in Professional Fighters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278354
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Flortaucipir F18 Procedure: Brain PET scan Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-AV-1451 PET Imaging in Professional Fighters
Actual Study Start Date : February 18, 2015
Actual Primary Completion Date : February 3, 2017
Actual Study Completion Date : February 3, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
 Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
  • [F-18]T807
  • 18F-AV-1451
  • LY3191748
  • Tauvid

Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Experimental: Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
 Drug: Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Other Names:
  • [F-18]T807
  • 18F-AV-1451
  • LY3191748
  • Tauvid

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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278354


Locations
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United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
Sponsors and Collaborators
Avid Radiopharmaceuticals
The Cleveland Clinic
  Study Documents (Full-Text)

Documents provided by Avid Radiopharmaceuticals:
Study Protocol  [PDF] July 13, 2015
Statistical Analysis Plan  [PDF] June 9, 2017

More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02278354    
Other Study ID Numbers: 18F-AV-1451-A11
First Posted: October 30, 2014    Key Record Dates
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders