Journal article
Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study
O Sabri, MN Sabbagh, J Seibyl, H Barthel, H Akatsu, Y Ouchi, K Senda, S Murayama, K Ishii, M Takao, TG Beach, CC Rowe, JB Leverenz, B Ghetti, JW Ironside, AM Catafau, AW Stephens, A Mueller, N Koglin, A Hoffmann Show all
Alzheimer S and Dementia | Published : 2015
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% C..
View full abstractGrants
Awarded by Japan Society for the Promotion of Science
Funding Acknowledgements
Medical writing support was provided by Dan Booth (Bioscript Medical, London, UK) and funded by Piramal Imaging S.A. Additional statistical analysis was carried out by Santi Bullich (Piramal Imaging GmbH).The trial was funded by Bayer Pharma AG, Berlin (Germany), and Piramal Imaging S.A., Matran (Switzerland). Bayer Pharma AG was involved in the design of the study; Bayer Pharma AG and Piramal Imaging SA were involved in the conduct of the study; collection, management, analysis, and interpretation of the data; and in the preparation, review, and approval of the manuscript.