PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
25
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
Healthy volunteers for whole body imaging: Single intravenous bolus injection of 185 MBq BAY85-8101, whole body PET for evaluation of effective dose, kinetics of BAY85-8101 in blood
Unnamed facility
Amsterdam, Netherlands
Unnamed facility
Stockholm, Sweden
Unnamed facility
Stockholm, Sweden
Visual analysis/description of the uptake and description of brain PET scans
Time frame: Day of study tracer administration
Standardized uptake value (SUV) in various cerebral regions/volumes of interest (ROI/VOI) assumed and found to be involved in the pathophysiology of Alzheimer's disease.
Time frame: Day of study tracer administration
Standard quantification variables derived from 3D PET imaging and brain modeling
Time frame: Day of study tracer administration
Standard Safety Measurement:adverse event collection
Time frame: Maximum time from Screening to Follow up are 37 days
Standard Safety Measurement:electrocardiogram
Time frame: Maximum time from Screening to Follow up are 37 days
Standard Safety Measurement:safety laboratory
Time frame: Maximum time from Screening to Follow up are 37 days
Standard Safety Measurement: vital signs
Time frame: Maximum time from Screening to Follow up are 37 days
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