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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

Tracking Information
First Submitted Date  ICMJE March 4, 2014
First Posted Date  ICMJE March 6, 2014
Results First Submitted Date  ICMJE June 27, 2020
Results First Posted Date  ICMJE September 7, 2020
Last Update Posted Date September 7, 2020
Study Start Date  ICMJE June 2014
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2020)
  • 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'.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2014)
  • CTE Biomarker Analysis [ Time Frame: Up to 100 minutes post injection ]
    18F-AV-1451 uptake and florbetapir F 18 standard uptake value ratio (SUVR) will be compared in subjects with a high risk of CTE and controls.
  • Relationship Between Clinical Presentation and Tau Deposition [ Time Frame: Up to 100 minutes post injection ]
    The relationship among 18F-AV-1451 uptake, florbetapir SUVR, and measurements including neuropsychological assessment battery (NAB) List and Story Learning tests, Trail Making Test - Parts A and B, Wisconsin Card Sorting Test, Wechsler Adult Intelligence Scale - Revised (WAIS-R), Animal Fluency, NAB Naming Test, NAB Map Reading Test and Mini-Mental State Examination (MMSE).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Official Title  ICMJE 18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Chronic Traumatic Encephalopathy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: High Risk of CTE
    Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
    Interventions:
    • Drug: florbetapir F 18
    • Drug: Flortaucipir F18
  • Experimental: Control
    Flortaucipir PET scans in former non-contact athletes
    Interventions:
    • Drug: florbetapir F 18
    • Drug: Flortaucipir F18
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2020)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2014)
30
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02079766
Other Study ID Numbers  ICMJE 18F-AV-1451-A07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Avid Radiopharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Avid Radiopharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
PRS Account Avid Radiopharmaceuticals
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP