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Examples
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The global Phase II, open-label, non randomized, multi-center study aimed to evaluate the efficacy and safety of florbetaben PET in vivo imaging in the detection/exclusion of cerebral beta-Amyloid plaques in patients with mild-to-moderate, probable AD (older than 55 years of age) compared with age-matched healthy volunteers.
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The results also showed a sensitivity of approximately 80 percent indicated by the clinical diagnosis, meaning that about 80 percent of the clinically suspected Alzheimer patients had positive florbetaben scans indicating the presence of beta-Amyloid plaques.
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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.
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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.
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Both volunteers without dementia and patients with dementia will be included, therefore enrolling subjects with either a high probability of cerebral beta-Amyloid deposition (e.g. subjects with AD) or a low probability of cerebral beta-Amyloid deposition (e. g.non-demented volunteers).
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The images will be compared for the presence or absence of cerebral beta-Amyloid respective to corresponding histo-pathological specimens.
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On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain.
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In the previous Phase II trial, florbetaben has successfully demonstrated its potential to detect beta-Amyloid deposition in the brain as a pathological hallmark of disease in AD patients.
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Both volunteers without dementia and patients with dementia will be included, therefore enrolling subjects with either a high probability of cerebral beta-Amyloid deposition (e.g. subjects with AD) or a low probability of cerebral beta-Amyloid deposition (e. g.non-demented volunteers).
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The global Phase II, open-label, non randomized, multi-center study aimed to evaluate the efficacy and safety of florbetaben PET in vivo imaging in the detection/exclusion of cerebral beta-Amyloid plaques in patients with mild-to-moderate, probable AD (older than 55 years of age) compared with age-matched healthy volunteers.
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