Tau Imaging in Professional Fighters
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ClinicalTrials.gov Identifier: NCT02278354 |
Recruitment Status :
Completed
First Posted : October 30, 2014
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer's Disease | Drug: Flortaucipir F18 Procedure: Brain PET scan | Phase 1 |
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 |

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

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

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
United States, Nevada | |
Cleveland Clinic Lou Ruvo Center for Brain Health | |
Las Vegas, Nevada, United States, 89106 |
Documents provided by Avid Radiopharmaceuticals:
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |