Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers
NCT01035164 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2015-01-08
Summary
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
Conditions
- Positron-Emission Tomography
- Alzheimer's Disease
Interventions
- DRUG
-
F-18 FEDAA1106 (BAY85-8101)
Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
- DRUG
-
F-18 FEDAA1106 (BAY85-8101)
Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET
- DRUG
-
F-18 FEDAA1106 (BAY85-8101)
Healthy volunteers for whole body imaging: Single intravenous bolus injection of 185 MBq BAY85-8101, whole body PET for evaluation of effective dose, kinetics of BAY85-8101 in blood
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Bayer Study Director · Bayer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-06-30
- Primary Completion
- 2010-01-31
- Completion
- 2010-01-31
Countries
- Netherlands
- Sweden
Study Locations
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