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Bayer HealthCare Pharmaceuticals Initiates Phase III Trial with Florbetaben PET Tracer for Imaging of Cerebral beta-Amyloid Plaques, a Pathological Hallmark of Alzheimer's Disease
Date:11/30/2009

WAYNE, N.J. and CHICAGO, Nov. 30 /PRNewswire/ -- Today at the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), Bayer HealthCare Pharmaceuticals Inc. announced the enrollment of the first patient in an international Phase III clinical trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid plaques in the brain, which are a pathological hallmark of Alzheimer's disease.

At present, diagnosis of Alzheimer's disease is based on cognitive tests that can only indicate a probability of having the disease. A definitive diagnosis of Alzheimer's disease is only possible through a post-mortem autopsy or brain tissue biopsy.

"We are pleased that with the initiation of the florbetaben Phase III clinical trials Bayer is moving forward on the development of a diagnostic tool that has the potential to enable a more definitive and earlier diagnosis of Alzheimer's disease," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals.

Phase III Trial Design

The pivotal phase III trial is an open-label, multi-center, non-randomized single dose
study to assess the safety and to determine the sensitivity and specificity of the visual and quantitative assessment of regional tracer uptake of florbetaben in the brain using PET imaging. Approximately 400 individuals are expected to be enrolled in this study. The florbetaben uptake pattern will be visually assessed by independent nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data. The images will be compared for the presence or absence of cerebral beta-Amyloid plaques respective to corresponding histo-pathological specimens. Both volunteers without dementia and patients with dementia will be included.

The primary and secondary objectives of the trial are the
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SOURCE Bayer HealthCare Pharmaceuticals
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