Sabri, OsamaSabbagh, Marwan N.Seibyl, JohnBarthel, HenrykAkatsu, HiroyasuOuchi, YasuomiSenda, KoheiMurayama, ShigeoIshii, KenjiTakao, MasakiBeach, Thomas G.Rowe, Christopher C.Leverenz, James B.Ghetti, BernardinoIronside, James W.Catafau, Ana M.Stephens, Andrew W.Mueller, AndreKoglin, NormanHoffman, AnjaRoth, KatrinReininger, CorneliaSchulz-Schaeffer, Walter J.2015-08-122015-08-122015Sabri, O., Sabbagh, M. N., Seibyl, J., Barthel, H., Akatsu, H., Ouchi, Y., ... & Florbetaben Phase 3 Study Group. (2015). Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer disease: Phase 3 study. Alzheimer's & Dementia.https://hdl.handle.net/1805/6631Background 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.en-USAttribution-NonCommercial 3.0 United StatesamyloidPETflorbetabenhistopathologyArticle