PET (positron emission tomography) imaging with BAY1006578 for investigation of diagnostic potential in probable Alzheimer Disease patients versus healthy volunteers and radiation dosimetry in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
24
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
Healthy volunteers for whole body imaging: Single intravenous bolus injection of 190 MBq BAY1006578, whole body PET for evaluation of effective dose, kinetics of BAY1006578 in blood
Unnamed facility
Turku, Finland
Unnamed facility
Stockholm, Sweden
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches
Time frame: Day 1 - day of study tracer administration
Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by visual analysis and by standard parameters (e.g. Standardized Uptake Values=SUV)
Time frame: Day 1 - day of study tracer administration
Electrocardiogram (ECG)
Time frame: At least once within 8 days after treatment
Blood pressure
Time frame: At least 2 times within 8 days after treatment
Adverse events collection
Time frame: Continuously and for a maximum of 28 days after end of observation phase
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