Study to Assess the Safety, Tolerability, Pharmacokinetics, Biomarker Effects, Efficacy, and Effect on Microglia Activation, as Measured by Positron Emission Tomography, of AZD3241 in Subjects with Multiple System Atrophy
What is the Background and Purpose of the Study?
This is a study of the drug AZD3241, which is an “investigational” drug. This means that AZD3241 has not been approved for use by the US Food and Drug Administration (FDA). AZD3241 is being investigated as a potential treatment of multiple system atrophy (MSA). This study will be conducted in approximately 64 subjects in approximately 11 centers in North America (approximately six centers) and Europe (approximately five centers). We expect to enroll about 10 patients recruited from Columbia University and an additional 10 patients from other participating sites who will come to Columbia University only for the PET scans.
- Male or female, age 30-80 years, inclusive, at screen.
- Meet criteria for diagnosis of probable or possible MSA according to the consensus criteria (Gilman et al. 2008 ).
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