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Clinical Evaluation of Flortaucipir F 18

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278367
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Traumatic Brain Injury Depression Drug: Flortaucipir F18 Procedure: Brain PET scan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of 18F-AV-1451
Actual Study Start Date : December 2014
Actual Primary Completion Date : June 26, 2019
Actual Study Completion Date : June 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Flortaucipir PET Scans Drug: Flortaucipir F18
IV injection, 370 MBq (10 mCi), up to two doses
Other Names:
  • [F-18]T807
  • 18F-AV-1451
  • LY3191748
  • Tauvid

Procedure: Brain PET scan
positron emission tomography (PET) scan of the brain


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events Related to Flortaucipir Administration [ Time Frame: within 48 hours of drug administration ]

    Frequency of treatment-emergent adverse events considered related to flortaucipir administration by the study investigator. Related events with a frequency > 1.5% are reported.

    (note: all treatment-emergent adverse events, regardless of relatedness designation, are reported in "Adverse Events" section below).


  2. Flortaucipir PET Scan SUVr [ Time Frame: baseline and follow-up scans ]
    Standard Uptake Value Ratio (SUVr) using a weighted cortical average. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Subjects should meet inclusion and exclusion criteria for the companion protocol in addition to the criteria below.

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278367


Locations
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United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06510
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Center for Vital Longevity at the University of Texas at Dallas
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Avid Radiopharmaceuticals
  Study Documents (Full-Text)

Documents provided by Avid Radiopharmaceuticals:
Study Protocol  [PDF] September 5, 2014
Statistical Analysis Plan  [PDF] December 6, 2019

More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02278367    
Other Study ID Numbers: 18F-AV-1451-A14
First Posted: October 30, 2014    Key Record Dates
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Injuries
Brain Injuries, Traumatic
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries