Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT00750282|
Recruitment Status : Completed
First Posted : September 10, 2008
Results First Posted : July 16, 2014
Last Update Posted : July 24, 2014
|Study Design||Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic|
Drug: Florbetaben (BAY94-9172)
There were two parts in this study, Part A and Part B. Part A was conducted in Australia, Germany, Switzerland and USA. Subjects were recruited from 17 centers. HVs were age matched to subjects with probable Alzheimer's (AD).
Part B was conducted in Australia, Germany, Japan, Switzerland, and USA, subjects recruited from 22 centers.
Part A screened 214 subjects; 113 AD and 101 HV. There were 63 screen failures (40 for inclusion criteria, 14 withdrew consent, 9 for other reasons) and one dropout prior to receiving study drug.
Part B screened 392 subjects; 204 AD and 188 HV. There were 118 screen failures for similar reasons and 2 dropouts prior to receiving study drug.