Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study

Osama Sabri*, Marwan N. Sabbagh, John Seibyl, Henryk Barthel, Hiroyasu Akatsu, Yasuomi Ouchi, Kohei Senda, Shigeo Murayama, Kenji Ishii, Masaki Takao, Thomas G. Beach, Christopher C. Rowe, James B. Leverenz, Bernardino Ghetti, James W. Ironside, Ana M. Catafau, Andrew W. Stephens, Andre Mueller, Norman Koglin, Anja HoffmannKatrin Roth, Cornelia Reininger, Walter J. Schulz-Schaeffer

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Abstract Background Evaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other dementias. Methods Open-label, nonrandomized, multicenter, phase 3 study to validate the 18F-labeled β-amyloid tracer florbetaben by comparing in vivo PET imaging with post-mortem histopathology. Results Brain images and tissue from 74 deceased subjects (of 216 trial participants) were analyzed. Forty-six of 47 neuritic β-amyloid-positive cases were read as PET positive, and 24 of 27 neuritic β-amyloid plaque-negative cases were read as PET negative (sensitivity 97.9% [95% confidence interval or CI 93.8-100%], specificity 88.9% [95% CI 77.0-100%]). In a subgroup, a regional tissue-scan matched analysis was performed. In areas known to strongly accumulate β-amyloid plaques, sensitivity and specificity were 82% to 90%, and 86% to 95%, respectively. Conclusions Florbetaben PET shows high sensitivity and specificity for the detection of histopathology-confirmed neuritic β-amyloid plaques and may thus be a valuable adjunct to clinical diagnosis, particularly for the exclusion of AD. Trial registration ClinicalTrials.gov NCT01020838.

Original languageEnglish
Article number1958
Pages (from-to)964-974
Number of pages11
JournalAlzheimer's & Dementia
Volume11
Issue number8
DOIs
Publication statusPublished - 1 Aug 2015

Keywords

  • Amyloid
  • Florbetaben
  • Histopathology
  • PET

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