NCT00109564已完成2 期
A Safety and Efficacy Study of TC-1734-112 in Subjects With Age Associated Memory Impairment (AAMI)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 25
- 主要终点
- To assess safety and tolerability of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
研究概览
简要总结
The purpose of this Phase II study is to evaluate the efficacy and safety of ispronicline (TC-1734-112) compared to placebo (inactive substance pill) in patients with age associated memory impairment (AAMI). AAMI is characterized as cognitive impairment including memory loss and poor concentration associated with aging.
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
- Double
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged 50-80 years.
- •Lives with a significant other.
- •Has subjective memory complaints. Verbal verification of this subjective memory complaint will be obtained from the significant other.
- •Has no severe, uncontrolled medical condition.
- •If receiving treatment for a medical condition, that treatment has been stable for at least 2 months before entering the trial and to remain stable throughout the trial.
- •Exclusion Criteria
- •Aged less than 50 years or greater than 80 years.
- •Lives alone.
- •Has any medical condition not adequately controlled, or likely to interfere with performance of the study procedures.
- •Medication for a medical condition has been changed in the last 2 months or during the trial.
- •Administration of acetylcholinesterase inhibitors and gingko biloba within 2 months prior to entering the study.
- •Has evidence of depression or anxiety
- •Meets DSM-IV criteria for Alzheimer's or vascular dementia.
- •Has participated in an investigational drug trial in the previous 30 days.
排除标准
- 未提供
结局指标
主要结局
To assess safety and tolerability of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
To assess effect, on cognition, of ispronicline vs. placebo in generally healthy elderly subjects with subjective and objective memory impairment meeting the generally accepted criteria for AAMI.
次要结局
未报告次要终点
研究者
研究点 (25)
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