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

NCT ID: NCT02079766

Last Updated: 2020-09-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Chronic Traumatic Encephalopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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High Risk of CTE

Flortaucipir PET scans in subjects at high risk of developing CTE (former National Football League players)

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

370 megabecquerel (MBq) IV single-dose

Flortaucipir F18

Intervention Type DRUG

370 megabecquerel (MBq) IV single-dose

Control

Flortaucipir PET scans in former non-contact athletes

Group Type EXPERIMENTAL

florbetapir F 18

Intervention Type DRUG

370 megabecquerel (MBq) IV single-dose

Flortaucipir F18

Intervention Type DRUG

370 megabecquerel (MBq) IV single-dose

Interventions

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florbetapir F 18

370 megabecquerel (MBq) IV single-dose

Intervention Type DRUG

Flortaucipir F18

370 megabecquerel (MBq) IV single-dose

Intervention Type DRUG

Other Intervention Names

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Amyvid 18F-AV-45 T807 18F-AV-1451 LY3191748

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chief Medical Officer

Role: STUDY_CHAIR

Avid Radiopharmaceuticals, Inc.

Locations

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Banner Alzheimer's Institute

Phoenix, Arizona, United States

Site Status

Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30969506 (View on PubMed)

Other Identifiers

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18F-AV-1451-A07

Identifier Type: -

Identifier Source: org_study_id

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