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Trial record 27 of 33 for:    alzheimer's disease | Recruiting Studies | United States, Florida | Adult, Senior | Phase 2, 3 | Industry

18F-AV-1451 Autopsy Study

This study is currently recruiting participants.
Verified November 2017 by Avid Radiopharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT02516046
First Posted: August 5, 2015
Last Update Posted: November 30, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
  Purpose
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 Intervention Phase
Alzheimer's Disease Drug: 18F-AV-1451 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Diagnostic Performance Individual Readers (NFT Score) [ Time Frame: Autopsy within 9 months of scan ]
    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) Scores of B2/B3 (Hyman et al., 2012; Montine et al., 2012).

  • Diagnostic Performance Individual Readers (NIA-AA Autopsy Diagnosis) [ Time Frame: Autopsy within 9 months of scan ]
    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 intermediate or high levels of AD neuropathologic change as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. Primary outcome 2 analysis will only be conducted if primary outcome 1 analysis is successful.


Secondary Outcome Measures:
  • Diagnostic Performance (NFT Score) [ Time Frame: Autopsy within 9 months of scan ]
    Sensitivity and specificity of majority interpretation from primary outcome 1.

  • Diagnostic Performance (NIA-AA Autopsy Diagnosis) [ Time Frame: Autopsy within 9 months of scan ]
    Sensitivity and specificity of majority interpretation from primary outcome 2.

  • Inter-Reader Agreement (NFT Score) [ Time Frame: Autopsy within 9 months of scan ]
    Fleiss' Kappa statistics will be used to assess inter-reader agreement for the diagnostic decisions associated with primary outcome 1.

  • Inter-Reader Agreement (NIA-AA Autopsy Diagnosis) [ Time Frame: Autopsy within 9 months of scan ]
    Fleiss' Kappa statistics will be used to assess inter-reader agreement for the diagnostic decisions associated with primary outcome 2.


Estimated Enrollment: 200
Study Start Date: September 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Avid Clinical Operations 215-298-0700 clinicaloperations@avidrp.com

  Show 39 Study Locations
Sponsors and Collaborators
Avid Radiopharmaceuticals
Investigators
Study Chair: Chief Medical Officer Avid Radiopharmaceuticals, Inc.
  More Information