Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study
Year: 2015
Type: article
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. TRIAL REGISTRATION: ClinicalTrials.govNCT01020838.
Source: Alzheimer s & Dementia
Authors: 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, Florbetaben Phase 3 Study Group
Institutions: University Hospital Leipzig, Leipzig University, Banner Sun Health Research Institute, Nagoya City University, Fukushimura Hospital, Hamamatsu University, Hamamatsu University School of Medicine, Tokyo Metropolitan Institute of Gerontology, Tokyo Metropolitan Geriatric Hospital, Institute of Gerontology, The University of Tokyo, Institute of Brain and Blood Vessels, The University of Melbourne, Austin Health, University of Washington, VA Puget Sound Health Care System, Indiana University Indianapolis, Indiana University School of Medicine, University of Edinburgh, Piramal (Germany), Bayer (Germany), Universitätsmedizin Göttingen
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,200
OpenAlex ID: W2169508236