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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
110
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.
Research Site
Phoenix, Arizona, United States
Research Site
Sun City, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Irvine, California, United States
Research Site
Fort Myers, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Miami Beach, Florida, United States
Research Site
Miami Springs, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Sarasota, Florida, United States
...and 12 more locations
Sensitivity Analysis in All Autopsy Population
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).
Time frame: at autopsy within 24 months of florbetapir PET scan
Specificity Analysis in All Autopsy Population
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).
Time frame: at autopsy within 24 months of florbetapir PET scan
Correlation of Florbetapir-PET Image and Amyloid Plaque Density
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.
Time frame: at autopsy within 24 months of florbetapir PET scan
Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan
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).
Time frame: at autopsy within 12 months of florbetapir PET scan
Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan
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).
Time frame: at autopsy within 12 months of florbetapir PET scan
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