Clinical Evaluation of Flortaucipir F 18

Completed · Phase 2

Conditions studied: Alzheimer's Disease, Traumatic Brain Injury, Depression

In brief

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 and analysis to facilitate companion studies including, but not limited to, longitudinal studies of aging, depression, and traumatic brain injury.

Key facts

Study ID

NCT02278367

Run by

Avid Radiopharmaceuticals

People needed

179

Starts

2014-12-01

Expected to finish

2019-06-26

Last updated by the study team

2020-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects who have a historical volumetric magnetic resonance imaging (MRI) as part of the companion study

You may not qualify if…

• 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

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• Yale University — New Haven, Connecticut, United States
• Cleveland Clinic Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Center for Vital Longevity at the University of Texas at Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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