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18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02079766
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Brief Summary:
This study will explore the use of flortaucipir as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.

Condition or disease Intervention/treatment Phase
Chronic Traumatic Encephalopathy Drug: florbetapir F 18 Drug: Flortaucipir F18 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy
Study Start Date : June 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: High Risk of CTE
Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
 Drug: florbetapir F 18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • Amyvid
  • 18F-AV-45

Drug: Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • T807
  • 18F-AV-1451
  • LY3191748
Experimental: Control
Flortaucipir PET scans in former non-contact athletes
 Drug: florbetapir F 18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • Amyvid
  • 18F-AV-45

Drug: Flortaucipir F18
370 megabecquerel (MBq) IV single-dose
Other Names:
  • T807
  • 18F-AV-1451
  • LY3191748


Outcome Measures
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Primary Outcome Measures :
  1. Flortaucipir Visual Read as CTE Biomarker [ Time Frame: Baseline scan ]
    Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.

  2. Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only) [ Time Frame: baseline scan ]
    The relationship between flortaucipir uptake and clinical presentation, as measured by the Mini-Mental State Examination (MMSE). Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. Specified in statistical analysis plan to only be conducted in High Risk of CTE group.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) or the Long-Term Consequences of Repetitive Brain Injury in Athletes study protocols
  • Can tolerate up to two PET imaging sessions
  • Have the ability to provide informed consent for study procedures

Exclusion Criteria:

  • Claustrophobia
  • 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
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): NCT02079766


Locations
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United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
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Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
More Information
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Publications of Results:

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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02079766    
Other Study ID Numbers: 18F-AV-1451-A07
First Posted: March 6, 2014    Key Record Dates
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Brain Diseases
Brain Injuries, Traumatic
Chronic Traumatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Brain Injuries
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Injury, Chronic
Neurodegenerative Diseases