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Last Updated: August 14, 2020

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CLINICAL TRIALS PROFILE FOR FLORBETABEN F-18

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All Clinical Trials for Florbetaben F-18

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00750282 Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers Completed Piramal Imaging SA Phase 2 2008-08-01 The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations
NCT00928304 Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid. Completed Piramal Imaging SA Phase 2 2009-06-01 To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS. Given that individuals with Down Syndrome develop β-amyloid pathology over the age of 40, the clinical diagnosis of Down Syndrome will serve as the standard of truth.
NCT01020838 Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology Completed Piramal Imaging SA Phase 3 2009-11-01 To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
NCT01138111 Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients Completed Piramal Imaging SA Phase 1 2008-06-01 The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI) progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.
NCT01222351 Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172 Recruiting Bayer N/A 2010-12-01 The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. Participants will be selected on the basis of change in plasma amyloid beta levels over prior assessment intervals. The purpose of the study is to examine whether brain amyloid plaque load, which will be measured with positron emission tomography and x-ray computed tomography brain imaging using Florbetaben from Bayer, varies as a function of change in plasma levels of amyloid beta. The driving hypothesis of the study is that high plasma levels of amyloid beta are an antecedent indicator of increased risk of cognitive decline, mild cognitive impairment, and incident late onset Alzheimer's disease, and that declining plasma levels of amyloid beta are associated with the onset of cognitive decline. Further, high plasma levels of amyloid beta are related to increased levels of amyloid beta in the brain as measured by positron emission tomography positivity, and the specific pattern of positron emission tomography positivity and a decline in plasma amyloid beta over time are associated with the onset of cognitive decline associated with late onset Alzheimer's disease.
NCT01222351 Measuring Brain Amyloid Plaque Load in Older Adults Using BAY 94-9172 Recruiting National Institute on Aging (NIA) N/A 2010-12-01 The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. Participants will be selected on the basis of change in plasma amyloid beta levels over prior assessment intervals. The purpose of the study is to examine whether brain amyloid plaque load, which will be measured with positron emission tomography and x-ray computed tomography brain imaging using Florbetaben from Bayer, varies as a function of change in plasma levels of amyloid beta. The driving hypothesis of the study is that high plasma levels of amyloid beta are an antecedent indicator of increased risk of cognitive decline, mild cognitive impairment, and incident late onset Alzheimer's disease, and that declining plasma levels of amyloid beta are associated with the onset of cognitive decline. Further, high plasma levels of amyloid beta are related to increased levels of amyloid beta in the brain as measured by positron emission tomography positivity, and the specific pattern of positron emission tomography positivity and a decline in plasma amyloid beta over time are associated with the onset of cognitive decline associated with late onset Alzheimer's disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Florbetaben F-18

Condition Name

Condition Name for Florbetaben F-18
Intervention Trials
Alzheimer Disease 4
Cardiac Amyloidosis 3
Amyloid Beta-Protein 3
Alzheimer's Disease 2
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Condition MeSH

Condition MeSH for Florbetaben F-18
Intervention Trials
Amyloidosis 8
Alzheimer Disease 8
Inflammation 2
Immunoglobulin Light-chain Amyloidosis 1
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Clinical Trial Locations for Florbetaben F-18

Trials by Country

Trials by Country for Florbetaben F-18
Location Trials
United States 19
Germany 6
Japan 6
Australia 5
Korea, Republic of 2
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Trials by US State

Trials by US State for Florbetaben F-18
Location Trials
New York 5
California 3
Arizona 3
Pennsylvania 2
Connecticut 2
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Clinical Trial Progress for Florbetaben F-18

Clinical Trial Phase

Clinical Trial Phase for Florbetaben F-18
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Florbetaben F-18
Clinical Trial Phase Trials
Recruiting 7
Completed 5
Not yet recruiting 3
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Clinical Trial Sponsors for Florbetaben F-18

Sponsor Name

Sponsor Name for Florbetaben F-18
Sponsor Trials
Piramal Imaging SA 4
National Institute on Aging (NIA) 3
William Charles Kreisl 2
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Sponsor Type

Sponsor Type for Florbetaben F-18
Sponsor Trials
Other 10
Industry 6
NIH 3
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