Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study
Open accessAbstract
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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These and other studies strongly support the concept of AD as an amyloid-provoked or facilitated tauopathy, although there is also evidence that both pathologies act in synergy.
“These and other studies 13,24,133,134 strongly support the concept of AD as being an amyloid-provoked, or facilitated, tauopathy, although there is also evidence that both pathologies act in synergy 135 .”
From The amyloid hypothesis in Alzheimer disease: new insights from new therapeutics (2022) · cites this paper as [135]
Positron emission tomography ligands have been shown to provide a minimally invasive estimate of the neuropathological features of Alzheimer disease, such as amyloid-β neuritic plaque deposition.
“Positron emission tomography (PET) ligands have been shown to provide a minimally invasive estimate of the neuropathological features of AD, such as Aβ neuritic plaque deposition.15,16,17,18”
From Positron Emission Tomography Imaging With [ <sup>18</sup> F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes (2020) · cites this paper as [18]
Large autopsy studies have demonstrated a high sensitivity and specificity for amyloid positron emission tomography to distinguish individuals with subsequent autopsy findings of no or sparse neuritic plaque from individuals with moderate to frequent plaque.
“For example, large autopsy studies have demonstrated a high sensitivity and specificity for amyloid PET to distinguish individuals with subsequent autopsy findings of no or sparse neuritic plaque from individuals with moderate to frequent plaque.16,17,18”
From Positron Emission Tomography Imaging With [ <sup>18</sup> F]flortaucipir and Postmortem Assessment of Alzheimer Disease Neuropathologic Changes (2020) · cites this paper as [18]
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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
- Venue
- Alzheimer's & Dementia
- Publisher
- Wiley
- Published
- 2015-03-27
- Volume
- 11
- Issue
- 8
- Pages
- 964-974
- ISSN
- 1552-5260 (ISSN-L)
- 1552-5279
- 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 · 2014: 1
- FWCI
- 39.00
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- 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
- Health Sciences › Medicine › Physiology › 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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