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

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.

Inclusion Criteria:

Study participants were individuals with DS and healthy volunteers (HVs).

• Main inclusion criteria for individuals without DS

  • >=21 and <= 40 years of age
  • Mini-Mental State Examination (MMSE) >= 28
  • Clinical Dementia Rating (CDR) of 0

• Main inclusion criteria for individuals with DS

  • >= 40 years of age

Exclusion Criteria:

• 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