PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
22
Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
Healthy volunteers for whole body imaging: Single intervenous bolus injection of 150 MBq BAY85-8102, whole body PET/CT for evaluation of effective dose, kinetics of BAY85-8102 in blood
Unnamed facility
Turku, Finland
Unnamed facility
Amsterdam, Netherlands
Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches
Time frame: Day of Study tracer administration
Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by visual analysis and standard parameters(e.g. Standardized Uptake Values = SUV)
Time frame: 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
Serum protein
Time frame: At least once within 8 days after treatment
Serum creatinine
Time frame: At least once within 8 days after treatment
Serum GOT (Glutamat-Oxalacetate-Transaminase)
Time frame: At least once 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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