Who is sponsoring NCT00928304?

NCT00928304 is sponsored by Life Molecular Imaging SA.

What condition does NCT00928304 study?

NCT00928304 studies Down Syndrome, Amyloid Beta-protein.

What drugs are being tested in NCT00928304?

Interventions: Florbetaben (BAY94-9172).

What is the status of NCT00928304?

NCT00928304 is currently COMPLETED.

Last reviewed 2014-01-29 · How we verify

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

NCT00928304 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Life Molecular Imaging SA
Phase	Phase 2
Status	COMPLETED
Enrolment	109
Start date	2009-06
Completion	2011-01

Conditions

Down Syndrome
Amyloid Beta-protein

Interventions

Florbetaben (BAY94-9172)

Primary outcomes

Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome — 100-120 min
The primary variables are sensitivity (percentage of DS subjects positive for cerebral beta-amyloid) and specificity (percentage of healthy volunteers negative for cerebral beta-amyloid) of brain uptake of florbetaben based on the majority read of the visual assessment by three independent blinded readers of PET images obtained 100 to 120 minutes post-injection of florbetaben.

Countries

United States