Diagnostic Imaging
Conditions
Keywords
Alzheimers disease, Diagnostic imaging, PET/CT diagnosis, PET tracer
Brief summary
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.
Interventions
DRUGF-18 DPA-714 (BAY85-8102)
Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to give fully informed consent in writing * Males or females aged \>/= 50 years * No significant disease or drug use * Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging: * Patient and designee capable of giving fully informed consent in writing * Patient fulfils DSM-IV and NINCDS-ADRA criteria for probable Alzheimers disease * Patient has undergone physical and neurological examination, ECG and test of routine hematological and biochemical parameters prior to radiotracer administration
Exclusion criteria
- Pregnancy or lactation * Current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Day of Study tracer administration |
Secondary
| Measure | Time frame |
|---|---|
| Electrocardiogram (ECG) | At least once within 8 days after treatment |
| Blood pressure | At least 2 times within 8 days after treatment |
| Serum protein | At least once within 8 days after treatment |
| 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) | Day of Study tracer administration |
| Serum GOT (Glutamat-Oxalacetate-Transaminase) | At least once within 8 days after treatment |
| Adverse events collection | Continuously and for a maximum of 28 days after end of observation phase |
| Serum creatinine | At least once within 8 days after treatment |
Countries
Finland, Netherlands
Outcome results
None listed