Status:
COMPLETED
Clinical Evaluation of Flortaucipir F 18
Lead Sponsor:
Avid Radiopharmaceuticals
Conditions:
Alzheimer's Disease
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is designed to expand the database of flortaucipir F 18 safety and tau binding as measured by PET imaging and to provide standardized conditions for flortaucipir PET use, data collection an...
Eligibility Criteria
Inclusion
- Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.
- Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study
Exclusion
- Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Have a screening electrocardiogram with a corrected QT interval (QTc) \> 450 msec if male or QTc \> 470 msec if female
- Have a history of additional risk factors for Torsades de Pointes (TdP) or are taking drugs known to cause QT-prolongation. Patients with a prolonged QTc interval in the setting of intraventricular conduction block may be enrolled with sponsor approval
- Have a history of drug or alcohol dependence within the last year, or prior prolonged history of dependence unless approved by the sponsor
- Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have a history of relevant severe drug allergy or hypersensitivity
- Are patients who have received an investigational medication within 30 days prior to the planned imaging session for this study
- Are patients with current clinically significant unstable medical comorbidities
- Are patients who have received a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT02278367
Start Date
December 1 2014
End Date
June 26 2019
Last Update
September 10 2020
Active Locations (5)
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1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
Yale University
New Haven, Connecticut, United States, 06510
3
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104