Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2015-02-18
2017-02-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy
NCT02079766
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
NCT02167594
Clinical Evaluation of Flortaucipir F 18
NCT02278367
Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein
NCT03071224
Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects
NCT02103894
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Flortaucipir F18
IV injection, 370 megabecquerel (MBq) (10 mCi)
Brain PET scan
positron emission tomography (PET) scan of the brain 75-105 minutes post injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Cleveland Clinic
OTHER
Avid Radiopharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18F-AV-1451-A11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.