Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447719
First received: May 20, 2011
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

This study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by histopathological assessment. The study will address the following specific aims:

  1. To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
  2. To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.

Condition Intervention Phase
Alzheimer's Disease
Drug: florbetapir F 18
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07

Resource links provided by NLM:


Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:
  • Sensitivity Analysis in All Autopsy Population [ Time Frame: at autopsy within 24 months of florbetapir PET scan ] [ Designated as safety issue: No ]
    Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).

  • Specificity Analysis in All Autopsy Population [ Time Frame: at autopsy within 24 months of florbetapir PET scan ] [ Designated as safety issue: No ]
    Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).

  • Correlation of Florbetapir-PET Image and Amyloid Plaque Density [ Time Frame: at autopsy within 24 months of florbetapir PET scan ] [ Designated as safety issue: No ]
    Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.


Secondary Outcome Measures:
  • Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan [ Time Frame: at autopsy within 12 months of florbetapir PET scan ] [ Designated as safety issue: No ]
    Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).

  • Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan [ Time Frame: at autopsy within 12 months of florbetapir PET scan ] [ Designated as safety issue: No ]
    Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative).


Enrollment: 110
Study Start Date: March 2010
Study Completion Date: July 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: florbetapir F 18
    No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.
    Other Names:
    • 18F-AV-45
    • Amyvid
    • florbetapir
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects are enrolled in this study if they:

  • Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07 (NCT00857415)
  • Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die
  • Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if required by the IRB
  • Reconfirm their consent to a research brain autopsy, if required by the IRB.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447719

Locations
United States, Arizona
Research Site
Phoeniz, Arizona, United States, 85006
Research Site
Sun City, Arizona, United States, 85351
United States, Arkansas
Research Site
Little Rock, Arkansas, United States, 72211
United States, California
Research Site
Irvine, California, United States, 92697
United States, Florida
Research Site
Fort Myers, Florida, United States, 33912
Research Site
Miami, Florida, United States, 33137
Research Site
Miami Beach, Florida, United States, 33140
Research Site
Miami Springs, Florida, United States, 33166
Research Site
Orlando, Florida, United States, 32835
Research Site
Sarasota, Florida, United States, 34231
Research Site
St. Petersburg, Florida, United States, 33709
Research Site
West Palm Beach, Florida, United States, 33407
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21221
United States, Mississippi
Research Site
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Research Site
St. Louis, Missouri, United States, 63141
United States, New York
Research Site
Albany, New York, United States, 12208
Research Site
New Hyde Park, New York, United States, 11040
United States, North Carolina
Research Site
Durham, North Carolina, United States, 27710
United States, Ohio
Research Site
Centerville, Ohio, United States, 45459
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73112
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29425
United States, Tennessee
Research Site
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
Avid Radiopharmaceuticals
  More Information

No publications provided

Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01447719     History of Changes
Other Study ID Numbers: 18F-AV-45-A16
Study First Received: May 20, 2011
Results First Received: April 6, 2012
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014