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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017166-24 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY1006578 | Drug | Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discrimination of probable Alzheimer's Disease patients from healthy volunteers by BAY1006578 brain Positron Emission Tomography (PET) imaging as evaluated by different quantification approaches | Day 1 - day of study tracer administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Day 1 - day of study tracer administration | |
| Electrocardiogram (ECG) |
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Inclusion Criteria:
All:
Healthy volunteers for brain imaging:
Patients for brain imaging:
Exclusion Criteria:
All:
Patients for brain imaging:
Healthy volunteers for brain imaging:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku | FIN-20520 | Finland | ||||
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| BAY1006578 | Drug | Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET |
|
| BAY1006578 | Drug | Healthy volunteers for whole body imaging: Single intravenous bolus injection of 190 MBq BAY1006578, whole body PET for evaluation of effective dose, kinetics of BAY1006578 in blood |
|
| At least once within 8 days after treatment |
| Blood pressure | At least 2 times within 8 days after treatment |
| Adverse events collection | Continuously and for a maximum of 28 days after end of observation phase |
| Stockholm |
| 141 86 |
| Sweden |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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