Piramal Imaging SA, a newly formed subsidiary of Piramal Healthcare Limited has updated positive results from a phase III study which showed that PET imaging with florbetaben reliably detects beta-amyloid in the brain during life with great accuracy and thus shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer’s disease.

The study results will be featured as part of the Emerging Science Programme on April 25 at the American Academy of Neurology’s 64th Annual Meeting in New Orleans.

Historically, the only way to definitively diagnose Alzheimer’s disease has been after death – at autopsy – through analysis and identification of beta-amyloid in brain tissue. The global phase III trial employed a unique and rigorous study design comparing in vivo brain PET imaging with florbetaben to post-mortem analysis of the brain tissue.

All study endpoints were met, and the study showed that PET imaging with florbetaben provided reliable, reproducible results. The visual assessment procedure proposed for routine clinical practice demonstrated 100 per cent sensitivity and 92 per cent specificity with excellent inter-reader agreement (kappa = 0.88).

Piramal has signed an agreement to acquire worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG through its newly created subsidiary – Piramal Imaging SA. Florbetaben is the lead compound in the portfolio.

“This is not only an important milestone for florbetaben, but it also marks an important milestone for our company,” says Dr Swati A Piramal, director, Piramal Healthcare Limited, “The creation of Piramal Imaging allows us to pursue our mission to increase diagnostic accuracy of 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 per cent and a specificity of 94 per cent with substantial inter-reader agreement (kappa = 0.66), significantly exceeding the pre-specified threshold, confirming the study hypotheses.

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.

Alzheimer's disease is a devastating neuro-degenerative disease and the most common cause of dementia. Most cases of Alzheimer's disease affect people over the age of 60. It is a progressive disease that can lead to premature death. At present there is no cure for Alzheimer's disease, but treatments for symptoms, combined with the right services and support, can make life better for the millions of people living with Alzheimer's.