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Title: Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer disease: Phase 3 study.
Austin Authors: Sabri, Osama;Sabbagh, Marwan N;Seibyl, John;Barthel, Henryk;Akatsu, Hiroyasu;Ouchi, Yasuomi;Senda, Kohei;Murayama, Shigeo;Ishii, Kenji;Takao, Masaki;Beach, Thomas G;Rowe, Christopher C ;Leverenz, James B;Ghetti, Bernardino;Ironside, James W;Catafau, Ana M;Stephens, Andrew W;Mueller, Andre;Koglin, Norman;Hoffmann, Anja;Roth, Katrin;Reininger, Cornelia;Schulz-Schaeffer, Walter J
Institutional Author: Florbetaben Phase 3 Study Group
Affiliation: Molecular Neuroimaging LLC, New Haven, CT, USA
Mihara Memorial Hospital, Isesaki, Japan
Banner Sun Health Research Institute, Sun City, AZ, USA
Department of Molecular Imaging and Therapy, Austin Health, Heidelberg, Victoria, Australia
University of Melbourne, Melbourne, Victoria, Australia
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.
Department of Neurology and Neuropathology, Tokyo Metropolitan Geriatric Hospital & Institute of Gerontology, Tokyo, Japan
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, IN, USA
VA-Puget Sound Health Care System and University of Washington, Seattle, WA, USA
Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany
Department of Biofunctional Imaging, Medical Photonics Research Center, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Koseikai Hospital, Toyohashi, Japan.
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan
Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, Scotland
Piramal Imaging GmbH, Berlin, Germany
Bayer Pharma AG, Berlin, Germany
Department of Neuropathology, University Medical Center Göttingen, Göttingen, Germany
Issue Date: 28-Mar-2015
Publication information: Alzheimer's & Dementia : the Journal of the Alzheimer's Association 2015; 11(8): 964-74
Abstract: Evaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other dementias.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.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.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.ClinicalTrials.govNCT01020838.
Gov't Doc #: 25824567
DOI: 10.1016/j.jalz.2015.02.004
ORCID: 0000-0003-3910-2453
PubMed URL: 25824567
Type: Journal Article
Subjects: Amyloid
Appears in Collections:Journal articles

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