Piramal Imaging, a subsidiary of Piramal Healthcare, reported positive results from a Phase III study which indicated that PET imaging with florbetaben detects beta-amyloid in the brain, giving it value as an aid in the diagnosis and assessment of Alzheimer’s disease.
Florbetaben is an 18F-labeled PET tracer which specifically binds to brain depositions of beta-amyloid containing proteins. 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 endpoints and showed that PET imaging with florbetaben provided reliable, reproducible results, according to the company.
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 results are not only an important milestone for florbetaben, but also mark an important milestone for the company.
"The creation of Piramal Imaging allows us to pursue our mission to increase diagnostic accuracy of serious medical conditions for improved patient outcomes," Piramal added.
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 in Louisiana, US, on 25 April 2012.
Image: PET imaging with florbetaben detects beta-amyloid in brain. Courtesy of PR Newswire / Piramal.