At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 218 enrolled
Drug / intervention
Florbetaben (BAY94-9172)drug
Likely dose
Florbetaben (BAY94-9172) 5mlfrom 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) Imaging for Detection/Exclusion of Cerebral Beta-amyloid When Compared to Postmortem Histopathology
In Brief
A Phase 3 clinical trial evaluating Florbetaben (BAY94-9172) for Alzheimer Disease. Completed, enrolled 218 participants across 19 sites in 5 countries.
Detailed Summary
To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesAustralia, France, Germany, Japan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2009
First PostedNov 2009
Primary CompletionSep 2011
Study CompletionDec 2013
TodayJul 2026
First PostedNov 26, 2009
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2011
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.6 years ago
Interventions
Florbetaben (BAY94-9172)drug
Single intravenous injection 1-5ml, 300 MBq (+/- 20%)