Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2006-006045-14 | EudraCT Number | ||
| 311401 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
PET (positron emission tomography) imaging with BAY85-8101 (ZK 6032924) in patients with Alzheimer's Disease compared to healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F-18 FEDAA1106 (BAY85-8101) | Drug | Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analysis/description of the uptake and description of brain PET scans | Day of study tracer administration | |
| 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. | Day of study tracer administration |
| Measure | Description | Time Frame |
|---|---|---|
| Standard quantification variables derived from 3D PET imaging and brain modeling | Day of study tracer administration | |
| Standard Safety Measurement:adverse event collection | Maximum time from Screening to Follow up are 37 days |
Not provided
Inclusion Criteria:Patients for brain imaging:- patient and designee capable of giving fully informed consent in writing- patient fulfils DSM-IV and NINCDS-ADRDA criteria for probable Alzheimer's disease. Other forms of dementia excluded- males or postmenopausal females aged >/= 50 yearsHealthy volunteers for brain imaging: - able to give fully informed consent in writing- absence of any sign of dementia/cognitive impairment in neuropsychological examinations- males or postmenopausal females aged >/= 50 years Healthy volunteers for whole body imaging:- able to give fully informed consent in writing - males or postmenopausal females aged >/= 60 years - no significant disease or drug use Exclusion Criteria:For all healthy volunteers and patients:- Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam | 1081 HV | Netherlands | ||||
Not provided
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| F-18 FEDAA1106 (BAY85-8101) | Drug | Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY85-8101 on day one of the treatment period, PET |
|
| F-18 FEDAA1106 (BAY85-8101) | Drug | 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 |
|
| Standard Safety Measurement:electrocardiogram | Maximum time from Screening to Follow up are 37 days |
| Standard Safety Measurement:safety laboratory | Maximum time from Screening to Follow up are 37 days |
| Standard Safety Measurement: vital signs | Maximum time from Screening to Follow up are 37 days |
| Stockholm |
| 141 86 |
| Sweden |
| Stockholm | 171 76 | Sweden |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D000090862 | Neuroinflammatory Diseases |
| 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 |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided