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Alzheimers Dement. 2015 Aug;11(8):964-74. doi: 10.1016/j.jalz.2015.02.004. Epub 2015 Mar 28.

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

Author information

1
Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany. Electronic address: osama.sabri@medizin.uni-leipzig.de.
2
Banner Sun Health Research Institute, Sun City, AZ, USA.
3
Molecular Neuroimaging LLC, New Haven, CT, USA.
4
Department of Nuclear Medicine, University of Leipzig, Leipzig, Germany.
5
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.
6
Department of Biofunctional Imaging, Medical Photonics Research Center, Hamamatsu University School of Medicine, Hamamatsu, Japan.
7
Koseikai Hospital, Toyohashi, Japan.
8
Department of Neurology and Neuropathology, Tokyo Metropolitan Geriatric Hospital & Institute of Gerontology, Tokyo, Japan; Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
9
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan.
10
Tokyo Metropolitan Institute of Gerontology, Tokyo, Japan; Mihara Memorial Hospital, Isesaki, Japan.
11
Department of Molecular Imaging, Austin Health, University of Melbourne, Melbourne, VIC, Australia.
12
VA-Puget Sound Health Care System and University of Washington, Seattle, WA, USA.
13
Department of Pathology and Laboratory Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
14
Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, Scotland.
15
Piramal Imaging GmbH, Berlin, Germany.
16
Bayer Pharma AG, Berlin, Germany.
17
Department of Neuropathology, University Medical Center Göttingen, Göttingen, Germany.

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.

KEYWORDS:

Amyloid; Florbetaben; Histopathology; PET

PMID:
25824567
DOI:
10.1016/j.jalz.2015.02.004
[Indexed for MEDLINE]
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