At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 109 enrolled
Drug / intervention
Florbetaben (BAY94-9172)drug
Likely dose
Florbetaben (BAY94-9172) 10 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Florbetaben (BAY94-9172) for Down Syndrome and Amyloid Beta-protein. Completed, enrolled 109 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDown Syndrome, Amyloid Beta-protein
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionJan 2011
TodayJul 2026
First PostedJun 25, 2009
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.0 years ago
Interventions
Florbetaben (BAY94-9172)drug
300 megabecquerels (MBq) as single IV injection of 2 to 10 mL