Conditions: Down Syndrome Amyloid Beta-protein
Keywords: Amyloid beta-protein Down Syndrome
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 109
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Florbetaben (BAY94-9172)
Intervention descriptions: intervention 1: 300 megabecquerels (MBq) as single IV injection of 2 to 10 mL

Protocol document: