Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study
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 the18 F-labeled β-amyloid tracer florbetaben by compari...
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| Published in | Alzheimer's & dementia Vol. 11; no. 8; pp. 964 - 974 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.08.2015
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| Subjects | |
| Online Access | Get full text |
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| 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 the18 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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| AbstractList | 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% 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. 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 the18 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. 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. 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 18F-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. |
| Author | Beach, Thomas G Ironside, James W Hoffmann, Anja Ishii, Kenji Ghetti, Bernardino Schulz-Schaeffer, Walter J Koglin, Norman Stephens, Andrew W Senda, Kohei Murayama, Shigeo Rowe, Christopher C Sabbagh, Marwan N Takao, Masaki Seibyl, John Mueller, Andre Reininger, Cornelia Leverenz, James B Roth, Katrin Catafau, Ana M Barthel, Henryk Sabri, Osama Akatsu, Hiroyasu Ouchi, Yasuomi |
| Author_xml | – sequence: 1 fullname: Sabri, Osama – sequence: 2 fullname: Sabbagh, Marwan N – sequence: 3 fullname: Seibyl, John – sequence: 4 fullname: Barthel, Henryk – sequence: 5 fullname: Akatsu, Hiroyasu – sequence: 6 fullname: Ouchi, Yasuomi – sequence: 7 fullname: Senda, Kohei – sequence: 8 fullname: Murayama, Shigeo – sequence: 9 fullname: Ishii, Kenji – sequence: 10 fullname: Takao, Masaki – sequence: 11 fullname: Beach, Thomas G – sequence: 12 fullname: Rowe, Christopher C – sequence: 13 fullname: Leverenz, James B – sequence: 14 fullname: Ghetti, Bernardino – sequence: 15 fullname: Ironside, James W – sequence: 16 fullname: Catafau, Ana M – sequence: 17 fullname: Stephens, Andrew W – sequence: 18 fullname: Mueller, Andre – sequence: 19 fullname: Koglin, Norman – sequence: 20 fullname: Hoffmann, Anja – sequence: 21 fullname: Roth, Katrin – sequence: 22 fullname: Reininger, Cornelia – sequence: 23 fullname: Schulz-Schaeffer, Walter J |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/25824567$$D View this record in MEDLINE/PubMed |
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| Copyright | The Authors 2015 The Authors 2015 The Alzheimer's Association Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved. |
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| Keywords | Florbetaben Amyloid Histopathology PET |
| Language | English |
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| Notes | Contributed equally. Osama Sabri received research grants, consultant and speaker honoraria and travel expenses from Bayer Healthcare/Piramal Imaging. Marwan W. Sabbagh has contracts or grants with Bayer Healthcare, Piramal Imaging, Navidea Biopharmaceuticals, Avid, GE Healthcare, Avanir, Elan, Functional Neuromodulation, Eisai, Pfizer, and Genentech, is a consultant for Lilly, Avid, Piramal Imaging, Biogen and Eisai, and receives royalties from Ten Speed and Wiley. John Seibyl holds equity interest in Molecular Neuroimaging and is a consultant to Piramal Imaging and GE Healthcare. Henryk Barthel received research grants, consultant and speaker honoraria and travel expenses from Bayer Healthcare/Piramal Imaging. Work by Hiroyasu Akatsu was partially supported by funding from Bayer. Kenji Ishii has been a paid consultant to GE Healthcare. Thomas G. Beach is a consultant for Avid Radiopharmaceuticals, GE Healthcare and Navidea Biopharmaceuticals, and has a research contract with Navidea Biopharmaceuticals. Christopher C. Rowe has received research grants from Bayer Schering Pharma. James B. Leverenz is a consultant with Bayer, Citibank, Piramal Imaging, and Navidea Biopharmaceuticals. James W. Ironside was a consultant with Covance UK, Bayer and Piramal Imaging and has received honoraria from Springer and Elsevier. Bernardino Ghetti was a consultant with Bayer and Piramal Imaging and has a research contract with Eli Lilly. Ana M. Catafau, Andrew W. Stephens, Andre Mueller, and Norman Koglin are employees of Piramal Imaging GmbH, Berlin, Germany. Anja Hoffmann and Katrin Roth are employees of Bayer Pharma AG, Berlin, Germany. Cornelia Reininger was an employee of Bayer Healthcare and is now an employee of Navidea Biopharmaceuticals as Chief Medical Officer. Walter J. Schulz‐Schaeffer received research grants from Bayer Healthcare and Piramal Imaging. The other authors declare no competing interests. Conflict of interest disclosures Listed in the Acknowledgments section. |
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| PublicationTitle | Alzheimer's & dementia |
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| Snippet | Abstract Background Evaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other... Evaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other dementias.... Background Evaluation of brain β‐amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other... |
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| SubjectTerms | Aged Aged, 80 and over Alzheimer Disease - diagnostic imaging Alzheimer Disease - metabolism Alzheimer Disease - pathology Amyloid Amyloid beta-Peptides - metabolism Analysis of Variance Aniline Compounds - pharmacokinetics Brain - diagnostic imaging Brain - metabolism Brain - pathology Cohort Studies Diagnosis Female Florbetaben Histopathology Humans Image Processing, Computer-Assisted Magnetic Resonance Imaging Male Middle Aged Neurology PET Plaque, Amyloid - pathology Positron-Emission Tomography Psychiatric Status Rating Scales Radiography ROC Curve Stilbenes - pharmacokinetics |
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| Title | Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study |
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