18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Primary Purpose
Chronic Traumatic Encephalopathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
florbetapir F 18
Flortaucipir F18
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Traumatic Encephalopathy
Eligibility 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
Sites / Locations
- Banner Alzheimer's Institute
- Boston University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
High Risk of CTE
Control
Arm Description
Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
Flortaucipir PET scans in former non-contact athletes
Outcomes
Primary Outcome Measures
Flortaucipir Visual Read as CTE Biomarker
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02079766
First Posted
March 4, 2014
Last Updated
September 3, 2020
Sponsor
Avid Radiopharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02079766
Brief Title
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
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 Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Traumatic Encephalopathy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Risk of CTE
Arm Type
Experimental
Arm Description
Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)
Arm Title
Control
Arm Type
Experimental
Arm Description
Flortaucipir PET scans in former non-contact athletes
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
Amyvid, 18F-AV-45
Intervention Description
370 megabecquerel (MBq) IV single-dose
Intervention Type
Drug
Intervention Name(s)
Flortaucipir F18
Other Intervention Name(s)
T807, 18F-AV-1451, LY3191748
Intervention Description
370 megabecquerel (MBq) IV single-dose
Primary Outcome Measure Information:
Title
Flortaucipir Visual Read as CTE Biomarker
Description
Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.
Time Frame
Baseline scan
Title
Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)
Description
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.
Time Frame
baseline scan
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30969506
Citation
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.
Results Reference
result
Learn more about this trial
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
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