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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
Last Update Posted : April 14, 2017
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 18F-AV-1451 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: 18F-AV-1451 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 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
Study Start Date : December 2014
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) will receive a single intravenous (IV) bolus injection of 370 megabecquerel (MBq) (10 millicurie [mCi]) of 18F-AV-1451.
 Drug: 18F-AV-1451
Other Name: [F-18]T807
Experimental: Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) will receive a single IV bolus injection of 370 MBq (10mCi) of 18F-AV-1451.
 Drug: 18F-AV-1451
Other Name: [F-18]T807


Outcome Measures
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Primary Outcome Measures :
  1. 18F-AV-1451 Uptake [ Time Frame: 75-105 minutes post injection ]
    Standard Uptake Value Ratios (SUVRs) by subject enrollment group (active/retired and cognitive impaired/normal) will be compared to detect differences across the enrollment 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
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
Last Update Posted: April 14, 2017
Last Verified: April 2017
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