BOSTON, Aug. 31, 2015 /PRNewswire/ -- Piramal Imaging announced today the publication of results from its pivotal Phase III trial of Neuraceq™ (florbetaben F18 injection), a radiopharmaceutical used with positron emission tomography (PET) imaging to estimate the density of neuritic beta-amyloid plaques in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. The results, which appear in the current issue of Alzheimer's & Dementia: The Journal of the Alzheimer's Association, demonstrate the high diagnostic accuracy of Neuraceq scans, making it a valuable beta-amyloid targeting PET tracer in the clinic with great potential to serve as biomarker supporting clinical AD diagnosis.
The Phase III results led to the March 2014 U.S. Food and Drug Administration (FDA) approval of Neuraceq for PET imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive decline. Neuraceq received marketing authorization from the European Commission in February 2014.
"Results from the phase III study validate an excellent consensus between the gold standard post-mortem pathology and florbetaben PET data, suggesting the very good suitability of florbetaben PET imaging for use in clinical practice," said lead author Osama Sabri, MD, PhD, Department of Nuclear Medicine at the University of Leipzig, Germany. "The high sensitivity and specificity for florabetaben PET were confirmed by histopathology in clinically relevant whole-brain visual analyses, enabling the estimation of amyloid pathology. Together with results from earlier studies, these latest data support the value of florbetaben PET as a diagnostic marker and a valuable adjunct for the exclusion of Alzheimer's disease or a differential diagnosis of dementia."
The open-label, non-randomized, multicenter, Phase III trial was designed to demonstrate the accuracy of Neuraceq by comparing in vivo PET imaging with post-mortem histopathology. In this study, investigators analyzed brain images and tissue from 74 deceased subjects, out of 216 trial participants who underwent Neuraceq injection and PET imaging; the participants included 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program.1
The investigators also conducted a tissue-scan matched regional analysis on a subgroup. In total, 244 tissue-matched regions of interest (ROIs) were analyzed. A high correlation between florbetaben accumulation and presence of beta-amyloid plaques was found.1
