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History of Changes for Study: NCT02079766
18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
Latest version (submitted September 3, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 4, 2014 None (earliest Version on record)
2 July 2, 2014 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 December 19, 2014 Eligibility, Study Status, Contacts/Locations, Outcome Measures, Study Design and Sponsor/Collaborators
4 February 5, 2015 Contacts/Locations and Study Status
5 April 2, 2015 Study Status and Contacts/Locations
6 November 18, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 February 8, 2017 Study Status
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Results Submission Events
8 September 3, 2020 Study Status, Arms and Interventions, More Information, Adverse Events, Outcome Measures, Baseline Characteristics, Participant Flow, References, Study Design, Study Description and Study Identification
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Study NCT02079766
Submitted Date:  March 4, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: 18F-AV-1451-A07
Brief Title: 18F-AV-1451 and Florbetapir F 18 PET 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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2014
Overall Status: Not yet recruiting
Study Start: April 2014
Primary Completion: December 2014 [Anticipated]
Study Completion: December 2014 [Anticipated]
First Submitted: March 4, 2014
First Submitted that
Met QC Criteria:
March 4, 2014
First Posted: March 6, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 4, 2014
Last Update Posted: March 6, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Avid Radiopharmaceuticals
Responsible Party: Sponsor
Collaborators: Boston University
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study will explore the use of 18F-AV-1451 as a biomarker for chronic traumatic encephalopathy (CTE) and examine the relationship between clinical presentation and tau deposition.
Detailed Description:
Open or close this module Conditions
Conditions: Chronic Traumatic Encephalopathy
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: High Risk of CTE
Subjects at high risk of developing CTE (former National Football League players) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of florbetapir F 18 and a single IV injection, 370 MBq (10 mCi) of 18F-AV-1451.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Names:
  • T807
Experimental: Control
Control subjects (former non-contact athletes) will receive a single IV injection, 370 megabecquerel (MBq) [10 millicurie (mCi)] of florbetapir F 18 and a single IV injection, 370 MBq (10 mCi) of 18F-AV-1451.
Drug: florbetapir F 18
Other Names:
  • Amyvid
  • 18F-AV-45
Drug: 18F-AV-1451
Other Names:
  • T807
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
2. 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).
Open or close this module Eligibility
Minimum Age: 40 Years
Maximum Age: 69 Years
Sex: Male
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Male subjects consented and currently enrolled in the Diagnosing and Evaluating Traumatic Encephalopathy Using Clinical Tests (DETECT) study protocol
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Avid Clinical Operations
Telephone: 215-298-0700
Email: clinicaloperations@avidrp.com
Study Officials: Chief Medical Officer
Study Chair
Avid Radiopharmaceuticals, Inc.
Locations: United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02118
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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