Piramal Imaging, a subsidiary of Piramal Healthcare, has reported positive results from a Phase III study which showed that PET imaging with florbetaben detects beta-amyloid in the brain and shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer's disease.
Florbetaben is an 18F-labeled PET tracer that specifically binds to brain depositions of beta-Amyloid containing proteins.
Piramal said, the only way to 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, compared in vivo brain PET imaging with florbetaben to post-mortem analysis of the brain tissue.
The trial met all the endpoints and showed that PET imaging with florbetaben provided reliable, reproducible results.
The visual assessment procedure proposed for routine clinical practice showed 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).
Piramal Healthcare director Swati A. Piramal said, "The creation of Piramal Imaging allows us to pursue our mission to increase diagnostic accuracy of serious medical conditions for improved patient outcomes."
Piramal said the study results will be featured as part of the Emerging Science Program at the American Academy of Neurology’s 64th Annual Meeting in New Orleans, Louisiana, US, on 25 April 2012.