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18F-AV-1451 High Resolution Autopsy Study

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: NCT02350634
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Description
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Brief Summary:
The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: 18F-AV-1451 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology
Study Start Date : June 2015
Actual Primary Completion Date : May 18, 2018
Actual Study Completion Date : May 18, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Autopsy Cohort
End-of-life subjects (life expectancy < 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of 18F-AV-1451.
 Drug: 18F-AV-1451
Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.
Other Name: [F-18]T807


Outcome Measures
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Primary Outcome Measures :
  1. Relationship of 18F-AV-1451 scan and pathology [ Time Frame: autopsy within 6 months of scan ]
    Correlation between 18F-AV-1451 standard uptake value ratio (SUVr) and neuropathology at autopsy.


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Projected life expectancy ≤ 6 months

Exclusion Criteria:

  • Primary brain tumor, known metastases to the brain, central nervous system lymphoma
  • Major, focal structural brain lesion
  • Aggressively being treated with life sustaining measures
  • Clinically significant infectious disease
  • History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation
  • Have received or participated in a trial with investigational medications in the past 30 days
  • Females of childbearing potential who are pregnant or not using adequate contraception
Contacts and Locations
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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): NCT02350634


Locations
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United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
United States, California
University of California, San Francisco
San Francisco, California, United States, 94121
Sponsors and Collaborators
Avid Radiopharmaceuticals
More Information
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Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02350634    
Other Study ID Numbers: 18F-AV-1451-A13
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders