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

September 3, 2020 updated by: Avid Radiopharmaceuticals

18F-AV-1451 and Florbetapir F 18 PET Imaging in Subjects With Repetitive Brain Trauma at High Risk for Chronic Traumatic Encephalopathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • 18F-AV-1451
  • LY3191748
  • T807
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:
  • 18F-AV-1451
  • LY3191748
  • T807

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
Baseline scan
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.
baseline scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avid Radiopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (Estimate)

March 6, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 3, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18F-AV-1451-A07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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