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18F-AV-1451 Autopsy Study

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ClinicalTrials.gov Identifier: NCT02516046
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Brief Summary:
This study is designed to test the relationship between ante-mortem 18F-AV-1451 Positron Emission Tomography (PET) imaging and tau neurofibrillary pathology associated with Alzheimer's disease (AD), as measured at autopsy.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: 18F-AV-1451 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Clinico-Pathological Study of the Correspondence Between 18F-AV-1451 PET Imaging and Post-Mortem Assessment of Tau Pathology
Study Start Date : September 2015
Actual Primary Completion Date : June 13, 2018
Actual Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autopsy Cohort
End-of-life subjects (life expectancy ≤ 6 months) consenting to brain donation at autopsy.
Drug: 18F-AV-1451
Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451. Some subjects may receive a second injection after 6 months have passed since the first injection.
Other Name: [F-18]T807




Primary Outcome Measures :
  1. Diagnostic Performance Individual Readers (NFT Score) [ Time Frame: 80-100 minutes post injection ]
    Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem 18F-AV-1451 PET imaging for detection of a pattern of 18F-AV-1451 neocortical uptake that corresponds to neurofibrillary tangles (NFT) Score of B3 (Hyman et al., 2012; Montine et al., 2012).

  2. Diagnostic Performance Individual Readers (NIA-AA Autopsy Diagnosis) [ Time Frame: 80-100 minutes post injection ]
    Sensitivity and specificity of 5 independent readers' interpretations of ante-mortem 18F-AV-1451 PET imaging for detection of a pattern of 18F-AV-1451 neocortical uptake that corresponds to high levels of AD neuropathologic change as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria.


Secondary Outcome Measures :
  1. Diagnostic Performance (NFT Score) [ Time Frame: 80-100 minutes post injection ]
    Sensitivity and specificity of majority interpretation from primary outcome 1.

  2. Diagnostic Performance (NIA-AA Autopsy Diagnosis) [ Time Frame: 80-100 minutes post injection ]
    Sensitivity and specificity of majority interpretation from primary outcome 2.

  3. Inter-Reader Agreement (NFT Score) [ Time Frame: 80-100 minutes post injection ]
    Fleiss' Kappa statistics will be used to assess inter-reader agreement for the diagnostic decisions associated with primary outcome 1.

  4. Inter-Reader Agreement (NIA-AA Autopsy Diagnosis) [ Time Frame: 80-100 minutes post injection ]
    Fleiss' Kappa statistics will be used to assess inter-reader agreement for the diagnostic decisions associated with primary outcome 2.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a projected life expectancy of ≤ 6 months
  • Can tolerate a 20 minute PET scan
  • Give informed consent or have a legally authorized representative to consent for study procedures and brain donation consistent with the legal requirements of the State in which they die

Exclusion Criteria:

  • Aggressively being treated with life sustaining measures
  • Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment
  • Clinically significant infectious disease
  • Currently receiving any investigational medications except with permission from the study sponsor
  • Participated in an experimental study with an amyloid or tau targeting agent
  • Suspected encephalopathy due to alcoholism or end-stage liver disease
  • Females of childbearing potential
  • History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation

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): NCT02516046


  Hide Study Locations
Locations
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Cherlin Research
Los Gatos, California, United States, 95032
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
California Research Foundation
San Diego, California, United States, 92103
Pacific Research Network
San Diego, California, United States, 92103
Ray Dolby Brain Health Center
San Francisco, California, United States, 94114
Syrentis Clinical Research
Santa Ana, California, United States, 92705
United States, Florida
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States, 33912
Galiz Research
Hialeah, Florida, United States, 33016
Merritt Island Medical Research
Merritt Island, Florida, United States, 32952
Miami Jewish Health Systems
Miami, Florida, United States, 33137
D de la Vega MD Research Group
Miami, Florida, United States, 33185
Bioclinica
Orlando, Florida, United States, 32806
United States, Georgia
Emory University Brain Health Center
Atlanta, Georgia, United States, 30329
United States, Massachusetts
Alzheimer's Disease Center
Quincy, Massachusetts, United States, 02169
United States, Nevada
Steinberg Diagnostics
Henderson, Nevada, United States, 89052
United States, New York
Adirondack Medical Research Center
Glens Falls, New York, United States, 12801
Clarity Clinical Research, LLC
Syracuse, New York, United States, 13210
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Valley Medical Primary Care
Centerville, Ohio, United States, 45459
Hospice of the Western Reserve
Cleveland, Ohio, United States, 44119
United States, Oklahoma
American Clinical Trials, LLC (Site 1216)
Oklahoma City, Oklahoma, United States, 73112
Oklahoma Behavioral Health
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Houston Methodist Research Institute
Houston, Texas, United States, 77030
Sante Clinical Research
Kerrville, Texas, United States, 78028
United States, Washington
Overlake Internal Medicine Associates, PS
Bellevue, Washington, United States, 98004
University of Washington Medicine
Seattle, Washington, United States, 98104
Australia, Victoria
University of Melbourne
Parkville, Victoria, Australia, 3010
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.