NCT00928304

Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.

An Open-Label, Non-Randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) for Detection of Cerebral ß-Amyloid in Individuals With Down Syndrome Compared to Individuals Without Down Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Down Syndrome
• Amyloid Beta-protein

Interventions

Type	Name	Description
DRUG	Florbetaben (BAY94-9172)	300 megabecquerels (MBq) as single IV injection of 2 to 10 mL

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-06-25
• Last updated: 2014-03-05
• Results posted: 2014-01-28

Locations

2 sites across 1 country: United States