Bayer HealthCare presented results from a global Phase II study of florbetaben, its imaging agent in development for the detection of cerebral beta-Amyloid plaques, at the 19th World Congress of Neurology (WCN).
The purpose of the Phase II study was to investigate the efficacy of florbetaben in differentiating between patients with a clinical diagnosis of probable Alzheimer's disease and Healthy Volunteers (HVs). Participants were evaluated using visual assessment of the uptake pattern of florbetaben in the brain and its ability to detect or exclude cerebral beta-Amyloid plaques. Cerebral beta-Amyloid plaques are one of the pathological hallmarks of Alzheimer's disease.
Current diagnosis of Alzheimer's disease is based on cognitive tests that can only indicate a probability of having the disease. A definitive clinical diagnosis of Alzheimer's disease is only possible through a post-mortem autopsy or brain tissue biopsy.
Florbetaben (BAY 94-9172) is an investigational positron emission tomography (PET) imaging tracer. In the global Phase II, open-label, non-randomized, multi-center study, florbetaben was used to detect or exclude the presence of cerebral beta-Amyloid plaques. A total of 81 men and women with probable mild-to-moderate Alzheimer's disease and 69 cognitively non-impaired healthy volunteers aged 55 and older were imaged with a single intravenous injection of florbetaben. The florbetaben uptake pattern was visually assessed for all time points by three independent, nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data.
Results showed that PET images using florbetaben had a specificity of approximately 90 percent. This means that the florbetaben scan indicated the presence of cerebral beta-Amyloid plaques in approximately 10 percent of the healthy volunteers. The results also showed a sensitivity of approximately 80 percent, meaning that about 80 percent of the subjects with probable Alzheimer's disease had florbetaben scans indicating the presence of cerebral beta-Amyloid plaques. This is consistent with the results of studies where the clinical diagnosis of Alzheimer's disease was compared with the definitive post-mortem histopathological diagnosis. Additional data analysis is still ongoing in this study.
There were twenty-nine treatment-emergent AEs, the most-frequent of which were injection site changes, were reported in 24 subjects (16 percent), 10 of whom were patients with probable Alzheimer's disease and 14 of whom were healthy volunteers. In two patients with probable Alzheimer's disease and three healthy volunteers, the AEs were deemed to be related to florbetaben, and included fatigue, "feeling hot", increased blood pressure, hematoma and "shaking of both hands." All adverse events (AEs) in the trial were resolved during the study period.
"Alzheimer's disease can be devastating for its victims and their families, and represents a large and growing cost burden for society," said Douglas Stefanelli, Vice President and General Manager, Diagnostic Imaging, Bayer HealthCare Pharmaceuticals. "At Bayer HealthCare Pharmaceuticals, we are pleased that these encouraging results from our phase II studies suggest the potential of florbetaben PET imaging as a valuable tool for the detection of the hallmark indicator associated with Alzheimer's disease."
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