check_circleStudy Completed
Positron-Emission Tomography, Alzheimer's Disease
Bayer Identifier:
91683
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Evaluation of ZK 6032924 in probable Alzheimer's disease patients versus healthy volunteers and the radiation dosimetry of ZK 6032924 in healthy volunteers
Trial purpose
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
Key Participants Requirements
Sex
BothAge
50 YearsTrial summary
Enrollment Goal
25Trial Dates
June 2007 - January 2010Phase
Phase 1Could I Receive a placebo
NoProducts
F18-FEDAA1106 (BAY85-8101)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Karolinska Universitetssjukhuset i Solna | Stockholm, 171 76, Sweden |
Completed | Karolinska Universitetssjukhuset Huddinge | Stockholm, 141 86, Sweden |
Completed | Vrije Universiteit Medisch Centrum | Amsterdam, 1081 HV, Netherlands |
Primary Outcome
- Visual analysis/description of the uptake and description of brain PET scansdate_rangeTime Frame:Day of study tracer administrationenhanced_encryptionnoSafety Issue:
- Standardized uptake value (SUV) in various cerebral regions/volumes of interest (ROI/VOI) assumed and found to be involved in the pathophysiology of Alzheimer's disease.date_rangeTime Frame:Day of study tracer administrationenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Standard quantification variables derived from 3D PET imaging and brain modelingdate_rangeTime Frame:Day of study tracer administrationenhanced_encryptionnoSafety Issue:
- Standard Safety Measurement:adverse event collectiondate_rangeTime Frame:Maximum time from Screening to Follow up are 37 daysenhanced_encryptionyesSafety Issue:
- Standard Safety Measurement:electrocardiogramdate_rangeTime Frame:Maximum time from Screening to Follow up are 37 daysenhanced_encryptionyesSafety Issue:
- Standard Safety Measurement:safety laboratorydate_rangeTime Frame:Maximum time from Screening to Follow up are 37 daysenhanced_encryptionyesSafety Issue:
- Standard Safety Measurement: vital signsdate_rangeTime Frame:Maximum time from Screening to Follow up are 37 daysenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
DiagnosticAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3Additional Information
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