Cited by 604Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsMedical Imaging Techniques and Applications

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Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study

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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., Florbetaben Phase 3 Study Group·2015·Alzheimer's & Dementia

DOI 10.1016/j.jalz.2015.02.004

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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.gov NCT01020838 .

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Authors: Sabri, O., Sabbagh, M. N., Seibyl, J., Barthel, H., Akatsu, H., Ouchi, Y., Senda, K., Murayama, S., Ishii, K., Takao, M., Beach, T. G., Rowe, C. C., Leverenz, J. B., Ghetti, B., Ironside, J. W., Catafau, A. M., Stephens, A. W., Mueller, A., Koglin, N., Hoffmann, A., Roth, K., Reininger, C., Schulz‐Schaeffer, W. J., & Florbetaben Phase 3 Study Group
Affiliations: University Hospital Leipzig (DE)
Banner Sun Health Research Institute (US)
Molecular Neuroimaging LLC New Haven CT USA
Nagoya City University (JP)
Hamamatsu University (JP)
Koseikai Hospital Toyohashi Japan
Tokyo Metropolitan Institute of Gerontology (JP)
Institute of Brain and Blood Vessels (JP)
The University of Melbourne (AU)
University of Washington (US)
Indiana University Indianapolis (US)
University of Edinburgh (GB)
Piramal (Germany) (DE)
Piramal Imaging GmbH Berlin Germany
Bayer (Germany) (DE)
Universitätsmedizin Göttingen (DE)
Corresponding author: Sabri, Osama
ORCID: Sabri, Osama
Sabbagh, Marwan N.
Seibyl, John
Barthel, Henryk
Akatsu, Hiroyasu
Ouchi, Yasuomi
Murayama, Shigeo
Ishii, Kenji
Takao, Masaki
Beach, Thomas G.
Rowe, Christopher C.
Leverenz, James B.
Ghetti, Bernardino
Ironside, James W.
Stephens, Andrew W.
Koglin, Norman
Roth, Katrin
Schulz‐Schaeffer, Walter J.
Venue: Alzheimer's & Dementia
Publisher: Wiley
Published: 2015-03-27
Volume: 11
Issue: 8
Pages: 964-974
ISSN: 1552-5260 (ISSN-L)
1552-5279
DOI: 10.1016/j.jalz.2015.02.004
OpenAlex: W2169508236
Cited by: 602
References: 33
Citations by year: 2026: 57 · 2025: 64 · 2024: 59 · 2023: 50 · 2022: 56 · 2021: 64 · 2020: 61 · 2019: 46 · 2018: 42 · 2017: 47 · 2016: 42 · 2015: 13
FWCI: 39.00
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
creativecommons.org/licenses/by-nc-nd/4.0/ (vor)
Locations: Alzheimer s & Dementia (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
GRO (submittedVersion)
Funders: Bioscript Medical
Piramal Imaging S.A
Bayer Pharma AG
Piramal Imaging S.A.
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Medical Imaging Techniques and Applications
Keywords: florbetaben, amyloid PET
MeSH terms: Aged, Aged, 80 and over, Alzheimer Disease, Analysis of Variance, Aniline Compounds, Brain, Diagnosis, Female, Humans, Image Processing, Computer-Assisted, Magnetic Resonance Imaging, Male, Middle Aged, Psychiatric Status Rating Scales, Radiography, ROC Curve, Stilbenes, Cohort Studies, Amyloid beta-Peptides, Positron-Emission Tomography, Plaque, Amyloid

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Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study

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