18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
NCT ID: NCT02079766
Last Updated: 2020-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2014-06-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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High Risk of CTE
Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
florbetapir F 18
370 megabecquerel (MBq) IV single-dose
Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
Control
Flortaucipir PET scans in former non-contact athletes
florbetapir F 18
370 megabecquerel (MBq) IV single-dose
Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
Interventions
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florbetapir F 18
370 megabecquerel (MBq) IV single-dose
Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Can tolerate up to two PET imaging sessions
* Have the ability to provide informed consent for study procedures
Exclusion Criteria
* 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
MALE
Yes
Sponsors
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Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Chief Medical Officer
Role: STUDY_CHAIR
Avid Radiopharmaceuticals, Inc.
Locations
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Banner Alzheimer's Institute
Phoenix, Arizona, United States
Boston University
Boston, Massachusetts, United States
Countries
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References
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Stern RA, Adler CH, Chen K, Navitsky M, Luo J, Dodick DW, Alosco ML, Tripodis Y, Goradia DD, Martin B, Mastroeni D, Fritts NG, Jarnagin J, Devous MD Sr, Mintun MA, Pontecorvo MJ, Shenton ME, Reiman EM. Tau Positron-Emission Tomography in Former National Football League Players. N Engl J Med. 2019 May 2;380(18):1716-1725. doi: 10.1056/NEJMoa1900757. Epub 2019 Apr 10.
Other Identifiers
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18F-AV-1451-A07
Identifier Type: -
Identifier Source: org_study_id
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