A Randomized, Double-Blind, Placebo-Controlled Study to Determine Safety and Tolerability of LX6171 Oral Suspension Dosed for 28 Days in Subjects Exhibiting Age Associated Memory Impairment (AAMI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Number of Subjects Reporting at Least One Adverse Event (AE)
研究概览
简要总结
The purpose of the study is to determine the safety, tolerability, and effectiveness of 2 dose levels of LX6171 given over 28 days in patients 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
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 60-80 years old.
- •Complaints of memory loss in everyday life
- •Non-smokers or very light smokers (no more than 10 cigarettes/day)
- •Negative urine screen for drugs of abuse
- •Ability to provide written informed consent
排除标准
- •History or evidence of any disease, disorder or injury that could cause cognitive deterioration.
- •Need for medications other than hormone replacement therapy, daily vitamins, or over-the-counter pain killers
- •Clinically significant abnormality on electrocardiogram
- •History of alcoholism or drug dependence
- •Use of dietary supplements containing Huperzine A, gingko biloba, phosphatidylserine, or Docosahexaenoic acid (DHA)
研究组 & 干预措施
High Dose
干预措施: LX6171 High Dose (Drug)
Low Dose
干预措施: LX6171 Low Dose (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects Reporting at Least One Adverse Event (AE)
时间窗: 28 days
An adverse event includes any noxious, pathological, or unintended change in anatomical, physiological, or metabolic functions as indicated by physical signs or symptoms occurring in any phase of the clinical study whether or not associated with the study medication and whether or not considered related to study medication.
Treatment Compliance
时间窗: End of study
Subjects were considered compliant if they had taken \>70% of possible doses of the study drug.
Number of Participants Who Were Exposed to LX6171
时间窗: 14 to18 days
Number of Subjects Reporting Adverse Events Leading to Withdrawal
时间窗: 28 days
次要结局
- Plasma Concentration(Day 28)
- Change From Baseline in Memory Assessment Clinics Self-Rating Scale Total Score at Day 28(Day 28)
- Change From Baseline (Day -1) in 15-Words Test: Acquisition Score at Day 28(Day 28)
- Change From Baseline in 15-Word Test: Short-Term Delayed Recall Score at Day 28(Day 28)
- Change From Baseline in Pittsburgh Sleep Quality Index at Day 28(Day 28)
- Change From Baseline in Epworth Sleepiness Scale at Day 28(Day 28)