title: Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: phase 3 study.
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 (18)F-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.
  
  
  BACKGROUND
  ClinicalTrials.govNCT01020838.
authors.affiliation: Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany. Electronic address: osama.sabri@medizin.uni-leipzig.de.
authors.forename: Osama
authors.initials: O
authors.lastname: Sabri
authors.affiliation: Banner Sun Health Research Institute, Sun City, AZ, USA.
authors.forename: Marwan N
authors.initials: MN
authors.lastname: Sabbagh
authors.affiliation: Molecular Neuroimaging LLC, New Haven, CT, USA.
authors.forename: John
authors.initials: J
authors.lastname: Seibyl
authors.affiliation: Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany.
authors.forename: Henryk
authors.initials: H
authors.lastname: Barthel
authors.affiliation: Fukushimura Hospital, Toyohashi, Japan; Department of Community-based Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya City, Aichi, Japan; Department of Neurology, Nagoya City University Graduate School of Medical Sciences, Nagoya City, Aichi, Japan.
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Akatsu
authors.affiliation: Department of Biofunctional Imaging, Medical Photonics Research Center, Hamamatsu University School of Medicine, Hamamatsu, Japan.
authors.forename: Yasuomi
authors.initials: Y
authors.lastname: Ouchi
authors.affiliation: Koseikai Hospital, Toyohashi, Japan.
authors.forename: Kohei
authors.initials: K
authors.lastname: Senda
authors.affiliation: Department of Neurology and Neuropathology, Tokyo Metropolitan Geriatric Hospital & Institute of Gerontology, Tokyo, Japan; Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
authors.forename: Shigeo
authors.initials: S
authors.lastname: Murayama
authors.affiliation: Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishii
authors.affiliation: Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan; Mihara Memorial Hospital, Isesaki, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Takao
authors.affiliation: Banner Sun Health Research Institute, Sun City, AZ, USA.
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Beach
authors.affiliation: Department of Molecular Imaging, Austin Health, University of Melbourne, Melbourne, VIC, Australia.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Rowe
authors.affiliation: VA-Puget Sound Health Care System and University of Washington, Seattle, WA, USA.
authors.forename: James B
authors.initials: JB
authors.lastname: Leverenz
authors.affiliation: Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Bernardino
authors.initials: B
authors.lastname: Ghetti
authors.affiliation: Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, Scotland.
authors.forename: James W
authors.initials: JW
authors.lastname: Ironside
authors.affiliation: Piramal Imaging GmbH, Berlin, Germany.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Catafau
authors.affiliation: Piramal Imaging GmbH, Berlin, Germany.
authors.forename: Andrew W
authors.initials: AW
authors.lastname: Stephens
authors.affiliation: Piramal Imaging GmbH, Berlin, Germany.
authors.forename: Andre
authors.initials: A
authors.lastname: Mueller
authors.affiliation: Piramal Imaging GmbH, Berlin, Germany.
authors.forename: Norman
authors.initials: N
authors.lastname: Koglin
authors.affiliation: Bayer Pharma AG, Berlin, Germany.
authors.forename: Anja
authors.initials: A
authors.lastname: Hoffmann
authors.affiliation: Bayer Pharma AG, Berlin, Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: Roth
authors.affiliation: Bayer Pharma AG, Berlin, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Reininger
authors.affiliation: Department of Neuropathology, University Medical Center Göttingen, Göttingen, Germany.
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Schulz-Schaeffer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000000981:diagnostic imaging / Q000378:metabolism / Q000473:pathology; D016229:Amyloid beta-Peptides / Q000378:metabolism*; D000704:Analysis of Variance; D000814:Aniline Compounds / Q000493:pharmacokinetics*; D001921:Brain / Q000000981:diagnostic imaging / Q000378:metabolism / Q000473:pathology; D015331:Cohort Studies; D003933:Diagnosis; D005260:Female; D006801:Humans; D007091:Image Processing, Computer-Assisted; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D058225:Plaque, Amyloid / Q000473:pathology*; D049268:Positron-Emission Tomography; D011569:Psychiatric Status Rating Scales; D012372:ROC Curve; D011859:Radiography; D013267:Stilbenes / Q000493:pharmacokinetics*
chemical_list: D016229:Amyloid beta-Peptides; D000814:Aniline Compounds; D013267:Stilbenes; C527756:4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene
keywords: Amyloid; Florbetaben; Histopathology; PET