Trial Condition(s):
Diagnostic Imaging
Evaluation of the neuroinflammation pattern of BAY85-8102 F-18, DPA-714 in probable Alzheimers disease patients versus healthy volunteers and radiation dosimetry of F 18, DPA-714 in healthy volunteers
Bayer Identifier:
13150
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Vrije Universiteit Medisch Centrum Amsterdam, Netherlands, 1081 HV | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Services Turku Turku, Finland, 20520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Open-label, non-randomized, multicenter positron emission tomography (PET) imaging study to evaluate a single dose of 250 MBq BAY85-8102 F-18, DPA-714 for its diagnostic potential in discriminating patients with probable Alzheimers disease from healthy volunteers and to evaluate the radiation dosimetry of a single dose of 150 MBq BAY858102 F-18, DPA-714 in healthy volunteers.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Diagnostic
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approachesTimeframe: Day of Study tracer administration
Secondary Outcome
- 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)Timeframe: Day of Study tracer administration
- Electrocardiogram (ECG)Timeframe: At least once within 8 days after treatment
- Blood pressureTimeframe: At least 2 times within 8 days after treatment
- Serum proteinTimeframe: At least once within 8 days after treatment
- Serum creatinineTimeframe: At least once within 8 days after treatment
- Serum GOT (Glutamat-Oxalacetate-Transaminase)Timeframe: At least once within 8 days after treatment
- Adverse events collectionTimeframe: Continuously and for a maximum of 28 days after end of observation phase
Additional Information
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