drugset / Trial / NCT00928304

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

NCT00928304

Phase 2 Completed 109 enrolled Lantheus Biosciences Ltd.
NaSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2009-06
Primary completion
2011-01
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Florbetaben Diagnostic / imaging agent 300 mbq Intravenous