Tau Imaging in Professional Fighters

Alzheimer's Disease Clinical Trial

Official title:

18F-AV-1451 PET Imaging in Professional Fighters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02278354
• Other study ID #: 18F-AV-1451-A11
• Status: Completed
• Phase: Phase 1
• Start date: February 18, 2015
• Est. completion date: February 3, 2017

Study information

• Verified date: August 2020
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 3, 2017
• Est. primary completion date: February 3, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)

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

Locations

Country	Name	City	State
United States	Cleveland Clinic Lou Ruvo Center for Brain Health	Las Vegas	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals	The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline scan
Primary	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.	baseline scan
Primary	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.	baseline scan
Primary	Flortaucipir Imaging (Qualitative) Between Fighter Groups	Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups	baseline scan