Biomarker Study of ATH434 in Participants With MSA
Study Details
Study Description
Brief Summary
This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: ATH434
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Drug: ATH434
ATH434 taken by mouth two times per day
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Outcome Measures
Primary Outcome Measures
- Change in iron content as measured by brain MRI [Change from Baseline to Week 52]
Secondary Outcome Measures
- Change in Aggregating alpha-Synuclein Levels [Change from Baseline to Week 52]
- Change in Neurofilament Light Chain Levels [Change from Baseline to Week 52]
- Change in Unified MSA Rating Scale (UMSARS) Score [Change from Baseline to Week 52]
- Change in 36-Item Short Form Survey (SF-36) Score [Change from Baseline to Week 52]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant has clinical features of parkinsonism.
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Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
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Participant has ataxia and/or pyramidal signs on neurological examination.
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Participant has biomarker evidence of MSA in biologic fluid and on MRI.
Exclusion Criteria:
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Participant is unable to swallow study drug.
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Participant is unable to attend study visits or complete study procedures.
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Participant has structural brain abnormality on MRI.
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Participant has any significant neurological disorder other than MSA.
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Participant has an unstable medical or psychiatric illness.
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Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
Sponsors and Collaborators
- Alterity Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ATH434-202