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This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20 patients to complete this study.The study will evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured via PET examinations.
A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson's Disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD3241 | Experimental | AZD3241 tablets 25 mg or 100 mg, titration first 5 days (50 mg bd on Day 1, 100 mg bd on Day 2, 200 mg bd on Day 3, 300 mg bd on Day 4, 400 mg bd on Day 5) Maintenance treatment from Day 6, 600 mg bd until Day 56±3 days |
|
| Placebo | Experimental | AZD3241 placebo bid for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ER tablet 25 mg AZD3241 | Drug | 2 tablets twice daily for Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET). | baseline, 2-4 weeks | |
| Change of binding of [11C]PBR28 to TSPO measured by PET. | baseline, 7-8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile. | Up to 10 weeks | |
| Change in plasma activity of myeloperoxidase (MPO). | baseline, up to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Svenningsson, MD, PHD | Karolinska University Hospital | Principal Investigator |
| Bjorn Paulsson, MD | AstraZeneca Medical Science Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reserach Site | Stockholm | Sweden | ||||
| Research Site |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C000602652 | AZD3241 |
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| ER tablet 100 mg AZD3241 |
| Drug |
1-6 tablets twice daily from Day 2 until Day 56±3 days |
|
| Placebo for AZD3241 25 mg | Drug | 2 tablets twice daily for Day 1 |
|
| Placebo for AZD3241 100 mg | Drug | 1-6 tablets twice daily from Day 2 until Day 56±3 days |
|
| Plasma concentrations of AZD3241. | Up to 8 weeks |
| Part of safety profile in terms of Columbia Suicide Severity Rating Scale. | Up to 10 weeks |
| Uppsala |
| Sweden |
| Research Site | Vällingby | Sweden |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |