Phase 1
N=35
Tau Imaging in Professional Fighters
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02278354 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Flortaucipir Imaging (Quantitative) Between Cognitive Groups — 1.0048; 0.971; 0.9731; 0.9357 standardized uptake value ratio (SUVr)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Flortaucipir F18 (Drug); Brain PET scan (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flortaucipir Imaging (Quantitative) Between Cognitive Groups |
1.0048; 0.971; 0.9731; 0.9357; 0.9867; 0.9305 | — |
| PRIMARY Flortaucipir Imaging (Quantitative) Between Fighter Groups |
0.9965; 0.9794; 0.9816; 0.9273; 0.9838; 0.9334 | — |
| PRIMARY Flortaucipir Imaging (Qualitative) Between Cognitive Groups |
16; 12; 2; 0; 0; 0 | — |
| PRIMARY Flortaucipir Imaging (Qualitative) Between Fighter Groups |
10; 18; 0; 2; 0; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02278354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.