A Phase 2 interventional study of ER tablet 25 mg AZD3241 and ER tablet 100 mg AZD3241 in Parkinson's Disease, sponsored by AstraZeneca. Completed at 3 sites in Sweden. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-01-31.
Sponsored by AstraZeneca · Phase 2, Interventional, and Basic science
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
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: ER tablet 25 mg AZD3241 · Drug: ER tablet 100 mg AZD3241
AZD3241 placebo bid for 8 weeks
Drug: Placebo for AZD3241 25 mg · Drug: Placebo for AZD3241 100 mg
2 tablets twice daily for Day 1
1-6 tablets twice daily from Day 2 until Day 56±3 days
2 tablets twice daily for Day 1
1-6 tablets twice daily from Day 2 until Day 56±3 days
Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET).
Time frame: baseline, 2-4 weeks
Change of binding of [11C]PBR28 to TSPO measured by PET.
Time frame: baseline, 7-8 weeks
Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile.
Time frame: Up to 10 weeks
Change in plasma activity of myeloperoxidase (MPO).
Time frame: baseline, up to 10 weeks
Plasma concentrations of AZD3241.
Time frame: Up to 8 weeks
Part of safety profile in terms of Columbia Suicide Severity Rating Scale.
Time frame: Up to 10 weeks
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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