Phase II study of Florbetaben (BAY94-9172) PET imaging for detection/exclusion of cerebral β-amyloid in individuals with Down Syndrome compared to individuals without Down Syndrome
To determine the sensitivity and specificity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) compared to 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.
- Main inclusion criteria for individuals without DS -- Mini-Mental State Examination (MMSE) which must be >= 28 -- Clinical Dementia Rating (CDR) of 0 - Main inclusion criteria for individuals with DS -- must be > 40 years of age
- Main exclusion criteria for both groups -- Unstable medical or psychiatric condition, study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time
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
Single Group Assignment