NCT01020838

Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology

An Open-label, Non-randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) Imaging for Detection/Exclusion of Cerebral Beta-amyloid When Compared to Postmortem Histopathology

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	Florbetaben (BAY94-9172)	Single intravenous injection 1-5ml, 300 MBq (+/- 20%)

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-09-01
• Completion: 2013-12-01
• First posted: 2009-11-26
• Last updated: 2016-05-27
• Results posted: 2015-03-25

Locations

19 sites across 5 countries: United States, Australia, France, Germany, Japan