check_circleStudy Completed
Diagnostic Imaging
Bayer Identifier:
14708
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Evaluation of the diagnostic potential of BAY1006578 in probable Alzheimers disease patients versus healthy volunteers and radiation dosimetry of BAY1006578 in healthy volunteers
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
50 - 100 YearsTrial summary
Enrollment Goal
24Trial Dates
June 2010 - October 2011Phase
Phase 1Could I Receive a placebo
NoProducts
[18F]FEMPA (BAY1006578)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Karolinska Universitetssjukhuset Huddinge | Stockholm, 141 86, Sweden |
Completed | Turun yliopistollinen keskussairaala, kantasairaala | Turku, FIN-20520, Finland |
Primary Outcome
- Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approachesdate_rangeTime Frame:Day 1 - day of study tracer administrationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- 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)date_rangeTime Frame:Day 1 - 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:
- 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