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Tau Imaging in Professional Fighters

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Flortaucipir F18

Brain PET scan

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

All Subjects

Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights
Can tolerate Positron Emission Tomography (PET) scan procedures
Have the ability to provide informed consent

Subjects with cognitive impairment

Have subjective cognitive complaints or objective decline or impairment as determined by the investigator

Exclusion Criteria:

Have behavior dysfunction that is likely to interfere with imaging
Are claustrophobic or otherwise unable to tolerate the imaging procedure
Have current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram
A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation
Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session
Have current drug or alcohol dependence or alcohol dependence within the past 2 years

Sites / Locations

Cleveland Clinic Lou Ruvo Center for Brain Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Active Professional Fighters

Retired Professional Fighters

Arm Description

Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan

Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan

Outcomes

Primary Outcome Measures

Flortaucipir Imaging (Quantitative) Between Cognitive Groups

Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Flortaucipir Imaging (Quantitative) Between Fighter Groups

Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.

Flortaucipir Imaging (Qualitative) Between Cognitive Groups

Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.

Flortaucipir Imaging (Qualitative) Between Fighter Groups

Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups

Secondary Outcome Measures

Full Information

NCT ID

NCT02278354

First Posted

October 28, 2014

Last Updated

August 21, 2020

Sponsor

Avid Radiopharmaceuticals

Collaborators

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02278354

Brief Title

Tau Imaging in Professional Fighters

Official Title

18F-AV-1451 PET Imaging in Professional Fighters

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

February 18, 2015 (Actual)

Primary Completion Date

February 3, 2017 (Actual)

Study Completion Date

February 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avid Radiopharmaceuticals

Collaborators

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Subjects enrolled in the Professional Fighters Brain Health Study (PFBHS) will receive flortaucipir to explore its use as a biomarker for brain injury related to repetitive head trauma and to 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

Alzheimer's Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Professional Fighters

Arm Type

Experimental

Arm Description

Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan

Arm Title

Retired Professional Fighters

Arm Type

Experimental

Arm Description

Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan

Intervention Type

Drug

Intervention Name(s)

Flortaucipir F18

Other Intervention Name(s)

[F-18]T807, 18F-AV-1451, LY3191748, Tauvid

Intervention Description

IV injection, 370 megabecquerel (MBq) (10 mCi)

Intervention Type

Procedure

Intervention Name(s)

Brain PET scan

Intervention Description

positron emission tomography (PET) scan of the brain 75-105 minutes post injection

Primary Outcome Measure Information:

Title

Flortaucipir Imaging (Quantitative) Between Cognitive Groups

Description

Time Frame

baseline scan

Title

Flortaucipir Imaging (Quantitative) Between Fighter Groups

Description

Time Frame

baseline scan

Title

Flortaucipir Imaging (Qualitative) Between Cognitive Groups

Description

Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.

Time Frame

baseline scan

Title

Flortaucipir Imaging (Qualitative) Between Fighter Groups

Description

Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups

Time Frame

baseline scan

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All Subjects Currently enrolled in the PFBHS protocol and have participated in a minimum of 10 professional fights Can tolerate Positron Emission Tomography (PET) scan procedures Have the ability to provide informed consent Subjects with cognitive impairment Have subjective cognitive complaints or objective decline or impairment as determined by the investigator Exclusion Criteria: Have behavior dysfunction that is likely to interfere with imaging Are claustrophobic or otherwise unable to tolerate the imaging procedure Have current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram A history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs that are known to cause QT-prolongation Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session Have current drug or alcohol dependence or alcohol dependence within the past 2 years

Facility Information:

Facility Name

Cleveland Clinic Lou Ruvo Center for Brain Health

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

12. IPD Sharing Statement

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Tau Imaging in Professional Fighters

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