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Clinical Evaluation of 18F-AV-1451

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 : Active, not recruiting
First Posted : October 30, 2014
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
This study is designed to expand the database of 18F-AV-1451 safety and tau binding as measured by PET imaging and to provide standardized conditions for 18F-AV-1451 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: 18F-AV-1451 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
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 : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 18F-AV-1451 PET Scans
Subjects will receive a single IV bolus injection of 370 MBq (10 mCi) of 18F-AV-1451. With prior sponsor approval, subjects in longitudinal companion studies may receive up to two injections of 18F-AV-1451 within a 12 month period.
Drug: 18F-AV-1451
370 megabecquerel (MBq) (10 millicurie [mCi])
Other Name: [F-18]T807




Primary Outcome Measures :
  1. Safety Assessment: Adverse event frequency related to 18F-AV-1451 administration [ Time Frame: 48 hours ]
    Adverse event frequency related to 18F-AV-1451 administration

  2. Efficacy Assessment: 18F-AV-1451 standard uptake value ratios (SUVRs) [ Time Frame: 80-100 minutes post injection ]
    18F-AV-1451 standard uptake value ratios (SUVRs) will be compared across diagnostic groups in the companion studies



Information from the National Library of Medicine

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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 MRI as part of the companion study

Exclusion Criteria:

  • Have clinically significant cardiac, hepatic, renal, pulmonary, metabolic, or endocrine disturbances
  • Have a screening ECG with 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 under an FDA IND protocol 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

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

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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
Last Update Posted: January 18, 2020
Last Verified: December 2019
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