Multicentre phase 3 trial on florbetaben for β-amyloid brain PET in Alzheimer disease

Objectives This phase 3 trial was carried out to substantiate that florbetaben PET can detect β-amyloid in the brain based on a regional comparison between scan and the respective post mortem specimen.

Methods 238 end-of-life patients were recruited from 17 centers across 4 continents. 204 of these individuals underwent MRI and florbetaben PET scanning and contributed 6 pre-specified regions for the efficacy analysis. 10 healthy individuals were also included to support specificity. Regional MRI-PET co-registered data were analyzed by 3 independent blinded readers. Visual assessment of PET scans using the method proposed for clinical practice was also performed.

Results A total 31 brains were included in the analysis. The regions were removed by the onsite pathologist, embedded in paraffin and sent to a central laboratory. The paraffin sections were sliced, silver- and immuno-stained for further analysis. To facilitate exact co-localization with the ante mortem MR-PET scans, the entire autopsy was photodocumented. These specimens were analyzed by a consensus panel of pathologists blinded to all clinical and imaging data.

Conclusions The results and methodological aspects of this pivotal trial will be presented.

Research Support This trial was supported by Bayer Healthcare Berlin (Germany)