NCT01406145已完成1 期
A Phase 1b, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Sequential Dose Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease on Donepezil
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number and percentage of subjects with adverse events
研究概览
简要总结
This study is intended to determine the safety and tolerability of ASP0777 in subjects with Alzheimer's Disease (AD) taking a stable dose of donepezil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a Mini-Mental Status Exam score of 18-26
- •Subject has a diagnosis of "probable" Alzheimer's Disease
- •Subject has used donepezil for at least 3 months and has been on a stable dose for at least 6 weeks prior to screening
- •Subject has a reliable adult who is residing with him/her during the outpatient portion of the study
- •Subject is medically stable
- •Subject has adequate cognitive, hearing, vision, and language skills
- •Subject is able to ingest oral tablets
排除标准
- •Subject has received any investigational product in another clinical study or post-marketing clinical study within past 3 months
- •Subject has any clinically significant abnormal laboratory tests
- •Subject is a female who is pregnant, lactating or of childbearing potential who refuses to use a form of contraception during the study
- •Subject has a history of a drug allergy or intolerance to memantine or a related compound
- •Subject is currently using anti-dementia drugs (except for donepezil) or has used any such drugs within the last 4 weeks
- •Subject has a score of 2 on item 16 of Cornell Scale for Depression in Dementia (CSDD) or has an overall CSDD score > 10
- •Subject is using off-label medicines, non-medicinal compounds, or dietary aids/food supplements to improve cognition that have not been at a stable dose for at least 4 weeks prior to Screening and/or are anticipated to change dosing regimen during the study
- •Subject has a history of drug or alcohol abuse within the past 12 months or subject consumes > 1 drink of alcohol daily, or is unable to refrain from alcohol during the study
- •Subject is a current smoker or recently quit smoking (within the past 12 months)
- •Subject has a clinically significant medical condition that is unstable or is likely to become unstable during the course of the study
- •Subject has history of seizures, other than febrile seizures during infancy
- •Subject has history of repeated falls within past 6 months
- •Subject has a major psychiatric illness or has received treatment for symptoms of a major psychiatric illness within past 1 year. Mild psychiatric disorders are allowable
研究组 & 干预措施
ASP0777 low dose
Experimental
ASP0777 low dose for 6 weeks
干预措施: ASP0777 (Drug)
ASP0777 low dose, then high dose
Experimental
ASP0777 low dose for 1 week and ASP0777 high dose for 5 weeks
干预措施: ASP0777 (Drug)
ASP0777 high dose
Experimental
ASP0777 high dose for 6 weeks
干预措施: ASP0777 (Drug)
Placebo
Placebo Comparator
Placebo for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number and percentage of subjects with adverse events
时间窗: Up to 56 Days
次要结局
- Pharmacokinetic assessment of AUC, maximum concentration (Cmax), minimum concentration (Cmin) and time to maximum concentration (tmax) through analysis of blood samples(Up to 56 Days)
研究者
研究点 (2)
Loading locations...
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