drugset / Trial / NCT01447719

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

NCT01447719

Phase 3 Completed 110 enrolled Avid Radiopharmaceuticals
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2010-03
Primary completion
2011-03
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject florbetapir Diagnostic / imaging agent

Indications