jRCT2080221473未知3 期
Open-label study to assess efficacy and safety of a single dose (i.v.) of NMA78 in patients with Dementia with Lewy Bodies (DLB) or Alzheimer's Disease (AD) and healthy volunteers (HV)
试验速览
- 阶段
- 3 期
- 入组人数
- 18
- 主要终点
- Safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Non-randomized, open-label
入排标准
- 年龄范围
- 35age old over 至 No limit（—）
- 性别
- All
入选标准
- •Healthy Japanese people.
- •Japanese patients clinically- diagnosed with DLB.
- •Japanese patients clinically- diagnosed with AD.
排除标准
- •People using following drugs: cocaine hydrochloride, mazindol, methylphenidate hydrochloride, sertraline hydrochloride.
- •Patients with hepatic, renal or hematopoietic dysfunction.
- •People with allergic reaction to alcohol or iodine.
- •Women who are pregnant, lactating or possibly pregnant.
结局指标
主要结局
Safety
subjective/objective symptoms, vital signs, electrocardiogram, clinical tests
Efficacy
diagnostic accuracy by reading committee
次要结局
未报告次要终点
研究者
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