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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


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Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.