check_circleStudy Completed
Diagnostic Imaging
Bayer Identifier:
13150
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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.
Key Participants Requirements
Sex
BothAge
50 YearsTrial summary
Enrollment Goal
22Trial Dates
October 2009 - October 2010Phase
Phase 1Could I Receive a placebo
NoProducts
F18 DPA-714 (BAY85-8102)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Vrije Universiteit Medisch Centrum | Amsterdam, 1081 HV, Netherlands |
Completed | Clinical Research Services Turku | Turku, 20520, Finland |
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 approachesdate_rangeTime Frame:Day of Study tracer administrationenhanced_encryptionnoSafety Issue:
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)date_rangeTime Frame:Day of Study tracer administrationenhanced_encryptionnoSafety Issue:
- Electrocardiogram (ECG)date_rangeTime Frame:At least once within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Blood pressuredate_rangeTime Frame:At least 2 times within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Serum proteindate_rangeTime Frame:At least once within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Serum creatininedate_rangeTime Frame:At least once within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Serum GOT (Glutamat-Oxalacetate-Transaminase)date_rangeTime Frame:At least once within 8 days after treatmentenhanced_encryptionyesSafety Issue:
- Adverse events collectiondate_rangeTime Frame:Continuously and for a maximum of 28 days after end of observation phaseenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3