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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT # 2011-000095-34 |
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In this study different mass of the radioligand AZD4694 will be given to patients with Alzheimer's Disease and healthy volunteers to evaluate wich Mass of AZD4694 that gives the best opportunities for following disease progress and treatment effects.
Open-Label Positron Emission Tomography Study with Selective Beta Amyloid Radioligand (18Fluor)AZD4694 to Assess the Effects of Varying Mass of AZD4694 on Radioligand Binding Parameters in Healthy Volunteers and Patients with Alzheimer's Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 Cohort 1 | Experimental | Patients with mild to moderate Alzheimer's Disease |
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| Part 1 Cohort 2 | Experimental | Patients with mild to moderate Alzheimer's Disease. To run if Maximum Detective Mass is detected in cohort 1. |
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| Part 2 | Experimental | Healthy Volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18Fluor]AZD4694 | Other | Low mass dose below 5ug. High mass dose around 40 and 50 ug. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum Diagnostic Mass by assessing the visual read out of amyloid status according to and quantification of an [18F]AZD4694 PET image in a high mass experiment compared to the image in a low mass experiment in the same subject. | Measuring the maximum chemical mass not causing any significant alteration of the amyloid status (unit = micrograms) | Visit 3 |
| The Maximum Diagnostic Mass by assessing the visual read out of amyloid status according to and quantification of an [18F]AZD4694 PET image in a high mass experiment compared to the image in a low mass experiment in the same subject. | Measuring the maximum chemical mass not causing any significant alteration of the amyloid status (unit = micrograms) | Visit 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events as a measure of Safety and tolerability of [18F]AZD4694 | Range of Visits 3-5 | |
| Correlation between early uptake of [18F]AZD4694 images and cerebral blood flow images as measured by Arterial Spin Labeling Magnetic resonance imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bjorn Paulsson | AstraZeneca | Study Director |
| Niels Andreasen, MD | Geriatric clinic Karolinska University Hospital Huddinge | Principal Investigator |
| Elisabeth Eden, MD | Quintiles Aktiebolag | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Stockholm | Sweden | ||||
| Research Site |
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| [18Fluor]AZD4694 |
| Other |
Low mass dose below 5ug. High mass dose around 20 ug. |
|
| [18Fluor]AZD4694 | Other | Low mass dose below 5ug. High mass dose will be the Maximum Detective Mass established in the previous panels. |
|
| Range of Screening Visit to Visit 4 |
| Correlation between estimates of β-amyloid load in brain obtained using [18F]AZD4694 Position Emission Tomography imaging and concentrations of β-amyloid in Cerebrospinal fluid | Range of Screening Visit to Visit 4 |
| Uppsala |
| Sweden |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| 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 |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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