Tau Imaging in Professional Fighters

Avid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Flortaucipir F18; Procedure: Brain PET scan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02278354

18F-AV-1451-A11

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

Active Professional Fighters

Experimental group

Description:

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

Treatment:

Drug: Flortaucipir F18

Procedure: Brain PET scan

Retired Professional Fighters

Experimental group

Description:

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

Treatment:

Drug: Flortaucipir F18

Procedure: Brain PET scan