Cerebral amyloid-β PET with florbetaben (18 F) in patients with Alzheimer's disease and healthy controls: a multicentre phase 2 diagnostic study

Summary Background Imaging with amyloid-β PET can potentially aid the early and accurate diagnosis of Alzheimer's disease. Florbetaben (18 F) is a promising18 F-labelled amyloid-β-targeted PET tracer in clinical development. We aimed to assess the sensitivity and specificity of florbetaben (18...

Full description

Saved in:
Bibliographic Details
Published in:Lancet neurology 2011-05, Vol.10 (5), p.424-435
Main Authors: Barthel, Henryk, Dr, Gertz, Hermann-Josef, MD, Dresel, Stefan, MD, Peters, Oliver, MD, Bartenstein, Peter, MD, Buerger, Katharina, MD, Hiemeyer, Florian, PhD, Wittemer-Rump, Sabine M, PhD, Seibyl, John, MD, Reininger, Cornelia, MD, Sabri, Osama, MD
Format: Article
Language:English
Subjects:
Aged
Alzheimer Disease - diagnosis
Alzheimer Disease - diagnostic imaging
Alzheimer Disease - metabolism
Amyloid beta-Peptides
Apolipoproteins E - genetics
Apolipoproteins E - metabolism
Diagnosis, Differential
Female
Fluorine Radioisotopes
Humans
Male
Middle Aged
Neurology
Positron-Emission Tomography - methods
Positron-Emission Tomography - standards
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Summary Background Imaging with amyloid-β PET can potentially aid the early and accurate diagnosis of Alzheimer's disease. Florbetaben (18 F) is a promising18 F-labelled amyloid-β-targeted PET tracer in clinical development. We aimed to assess the sensitivity and specificity of florbetaben (18 F) PET in discriminating between patients with probable Alzheimer's disease and elderly healthy controls. Methods We did a multicentre, open-label, non-randomised phase 2 study in 18 centres in Australia, Germany, Switzerland, and the USA. Imaging with florbetaben (18 F) PET was done on patients with probable Alzheimer's disease (age 55 years or older, mini-mental state examination [MMSE] score=18–26, clinical dementia rating [CDR]=0·5–2·0) and age-matched healthy controls (MMSE ≥28, CDR=0). Our primary objective was to establish the diagnostic efficacy of the scans in differentiating between patients with probable disease and age-matched healthy controls on the basis of neocortical tracer uptake pattern 90–110 min post-injection. PET images were assessed visually by three readers masked to the clinical diagnosis and all other clinical findings, and quantitatively by use of pre-established brain volumes of interest to obtain standard uptake value ratios (SUVRs), taking the cerebellar cortex as the reference region. This study is registered with ClinicalTrials.gov , number NCT00750282. Findings 81 participants with probable Alzheimer's disease and 69 healthy controls were assessed. Independent visual assessment of the PET scans showed a sensitivity of 80% (95% CI 71–89) and a specificity of 91% (84–98) for discriminating participants with Alzheimer's disease from healthy controls. The SUVRs in all neocortical grey-matter regions in participants with Alzheimer's disease were significantly higher (p
ISSN:1474-4422
1474-4465
DOI:10.1016/S1474-4422(11)70077-1