NCT02013310已完成2 期
A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing HT-0712 With Placebo in Subjects With Age-Associated Memory Impairment (AAMI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 主要终点
- Cognitive Drug Research™ (CDR) Study Specific Test Battery
研究概览
简要总结
This is a Phase 2 randomized, multicenter, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy of HT-0712 in improving memory and cognitive performance in subjects with Age-Associated Memory Impairment (AAMI)
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Complaints of memory loss in everyday life
- •Performance at least one standard deviation below the mean established for young adults on standardized memory tests
- •Absence of dementia
- •Intact global intellectual function
排除标准
- •Diagnosis of Mild Cognitive Impairment (MCI) or Alzheimer's Disease
- •Evidence of dementia
- •Evidence of psychiatric or neurological disorder that could influence cognition or contributed to the subject's memory loss
- •Use of any drugs that could influence cognition
研究组 & 干预措施
HT-0712 (50mg)
Experimental
HT-0712 capsules administered once daily.
干预措施: HT-0712 (Drug)
Placebo
Placebo Comparator
Placebo capsules administered once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Cognitive Drug Research™ (CDR) Study Specific Test Battery
时间窗: Weekly over the course of 6-weeks
次要结局
- Subject Global Impression Scale of Cognition (SGI-Cog)(Weekly over the course of 6-weeks)
- Paired Associated Learning and Memory Test(Weekly over the course of 6-weeks)
研究者
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