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Encouraging Phase III Study Results Show PET Imaging with Florbetaben Reliably Detects Beta-Amyloid in the Brain
Date:4/15/2012

serious medical conditions for improved patient outcomes."  Dr. Piramal also serves on the Dean's Advisory Board of both the Harvard School of Public Health and Harvard Business School.

This pivotal trial is the first to overlay MRI and PET data to accurately match florbetaben gray matter uptake with disease in six defined regions of the brain.  This was done to confirm that florbetaben binds to beta-Amyloid on both a regional (brain sections) and subject (whole brain) level. This combination provides considerably more data points than any other beta-Amyloid tracer trial to date. Based on a region-by-region comparison, florbetaben detected beta-Amyloid with a sensitivity of 77% and a specificity of 94% with substantial inter-reader agreement (kappa = 0.66), significantly exceeding the pre-specified threshold, confirming the study hypotheses.

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About Florbetaben (BAY 94-9172)

Florbetaben is an 18F-labeled PET tracer that specifically binds to deposition of beta-Amyloid. These depositions (plaques) consist of proteins that accumulate in the brain and are a pathological hallmark of Alzheimer's disease. As the aggregation of the beta-Amyloid protein in the brain is also a key target for new therapeutic treatments under development, florbetaben might also be able to support the development of these new treatment approaches. A Phase II study showed that patients with clinical diagnosis of Alzheimer's disease could be differentiated from age-matched healthy volunteers on the basis of florbetaben uptake pattern in the brain. The results of the Phase II study were presented at the International Conference on Alzheimer's diseases (ICAD) in Vienna, Austria in July 2009 and published in the Lancet Neurology in April 2011.

About Alzheimer's Disease

Alzheimer's disease is a devastating neuro-degenerative disease and the most common cause of dementia. Most cases of Alzheimer's disea
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SOURCE Piramal Healthcare Limited
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