NCT05864365已完成2 期
An Open-Label Biomarker Study of ATH434 in Multiple System Atrophy
Alterity Therapeutics1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年5月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change in brain volume as measured by MRI
研究概览
简要总结
This study will assess the safety and efficacy of ATH434 in participants with a clinical diagnosis of Multiple System Atrophy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has clinical features of parkinsonism.
- •Participant has evidence of orthostatic hypotension and/or bladder dysfunction.
- •Participant has ataxia and/or pyramidal signs on neurological examination.
- •Participant has biomarker evidence of MSA in biologic fluid and on MRI.
排除标准
- •Participant is unable to swallow study drug.
- •Participant is unable to attend study visits or complete study procedures.
- •Participant has structural brain abnormality on MRI.
- •Participant has any significant neurological disorder other than MSA.
- •Participant has an unstable medical or psychiatric illness.
- •Participant has a contraindication to, or is unable to tolerate, MRI or lumbar puncture.
研究组 & 干预措施
ATH434
Experimental
干预措施: ATH434 (Drug)
结局指标
主要结局
Change in brain volume as measured by MRI
时间窗: Change from Baseline to Week 52
次要结局
- Change in iron content in substantia nigra as measured by MRI(Change from Baseline to Week 52)
- Change in Unified MSA Rating Scale (UMSARS) Score(Change from Baseline to Week 52)
- Change in Patient Global Impression of Change (PGI-C)(Change from Baseline to Week 52)
- Change in Clinical Global Impression of Change (CGI-C)(Change from Baseline to Week 52)
- Change in Neurofilament Light Chain Levels(Change from Baseline to Week 52)
研究者
研究点 (1)
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