NL-OMON42784已完成2 期
A Randomized, double blind, placebo-controlled, parallel-group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CNP520 in healthy elderly subjects - Randomized study safety, PK PD of multiple doses CNP520 in healthy subjects
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Written informed consent must be obtained before any assessment is performed.
- •3. Total MMSE score >=25 for subjects with low educational attainment (12 or fewer years of education) or >=27 for subjects with high educational attainment (13 or more years of education).
- •4. Ability to perform cognitive assessments (i.e. Cogstate battery as defined in the SOM).
- •5. Subjects must weigh at least 45 kg to participate in the study, and must have a body mass index (BMI) within the range of >=18 to <=34 kg/m2. BMI = Body weight (kg) / [Height (m2)].
- •6. Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
排除标准
- •2. History of hypersensitivity to BACE inhibitors.
- •9. Score yes on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or yes on any item of the Suicidal Behavior section, except for the Non-Suicidal SelfInjurious Behavior, if this behavior occurred in the past 2 years.
- •11. Heavy smokers.
- •17. Subject is mentally or legally incapacitated or has significant emotional problems in the opinion of the investigator.
研究者
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