Skip to main content
OpenTrials
Completed

NCT Number: NCT01447719

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

florbetapir F 18

Drug

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

Primary outcomes

  1. Sensitivity Analysis in All Autopsy Population

    Time frame: at autopsy within 24 months of florbetapir PET scan

    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).

  2. Specificity Analysis in All Autopsy Population

    Time frame: at autopsy within 24 months of florbetapir PET 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).

  3. Correlation of Florbetapir-PET Image and Amyloid Plaque Density

    Time frame: at autopsy within 24 months of florbetapir PET scan

    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 outcomes

  1. Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan

    Time frame: at autopsy within 12 months of florbetapir PET 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).

  2. Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan

    Time frame: at autopsy within 12 months of florbetapir PET 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).

Other outcomes

  1. Median Sensitivity and Specificity vs. CERAD Diagnosis

    Time frame: at autopsy within 24 months of florbetapir PET scan

    Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria).

  2. Individual Reader Results (All Scans With Autopsy)

    Time frame: at autopsy within 24 months of florbetapir PET scan

    Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy.

  3. Individual Reader Results (Autopsy Within 1 Year of Scan)

    Time frame: at autopsy within 12 months of florbetapir PET scan

    Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy.

Sponsors and collaborators

Lead sponsor

Avid Radiopharmaceuticals

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2011
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.