Trials / Completed
CompletedNCT01035164
Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers
Open-label, Non-randomized, Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq (6.75 mCi) ZK 6032924 (18F-FEDAA1106) for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimer's Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 185 MBq (5 mCi) ZK 6032924 in Healthy Volunteers.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2009-12-18
- Last updated
- 2015-01-08
Locations
3 sites across 2 countries: Netherlands, Sweden
Source: ClinicalTrials.gov record NCT01035164. Inclusion in this directory is not an endorsement.