• 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 Hoffmann, Katrin Roth, Cornelia Reininger, Walter J Schulz-Schaeffer, and Florbetaben Phase 3 Study Group.
• Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany. Electronic address: osama.sabri@medizin.uni-leipzig.de.
• Alzheimers Dement. 2015 Aug 1; 11 (8): 964-74.

BackgroundEvaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other dementias.MethodsOpen-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.ResultsBrain 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.ConclusionsFlorbetaben 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 RegistrationClinicalTrials.govNCT01020838.Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

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