A Phase II, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Assessing the Efficacy and Safety of AC-3933 Tablets Twice Daily in Adults With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 33
- 主要终点
- Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)
研究概览
简要总结
The purpose of this study is to investigate efficacy and safety of different doses of AC-3933 in patients with mild to moderate Alzheimer's Disease.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate Alzheimer's Disease
- •Male or female 55 years or older
- •Living with caregiver
- •Read, understand and speak English
排除标准
- •Need to drive during the study
- •Treatment with acetylcholinesterase inhibitors or NMDA antagonist, such as Aricept or Namenda, within 2 weeks of check-up and during the study
- •Frequent Smoker
- •Frequent Consumer of Caffeine
研究组 & 干预措施
AC-3933
AC-3933, 5mg twice daily
干预措施: AC-3933 (Drug)
AC-3933, 20 mg twice daily
AC-3933, 20 mg twice daily
干预措施: AC-3933 (Drug)
Placebo
Sugar Pill twice daily
干预措施: Sugar Pill (Other)
结局指标
主要结局
Total Score of Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG)From Best Total Score (0) to Worst Total Score (70)
时间窗: Baseline to 16 weeks
Change from baseline to week 16 of the double blind treatment in the Alzheimer's Disease Assessment Scale - Cognition Subscale (ADAS-COG) total score The Alzheimer's Disease Assessment Scale if used for assessing the severity of dysfuncion and for research in patients with AD, particularly in clinical drug trials. It consists of 11 items testing orientatin, memory, word usage and recognition, receptive speech, spatial abilities, ideational praxis, ability to follow instructions, spontanious speech abilities, and comprehension. The higher the overall score (maximum 70), the more severe the dysfunction/impairment.
次要结局
- Clinicians Interview Based Impression of Change (CIBIC)-Plus(Baseline to 16 weeks)
- Disability Assessment for Dementia (DAD)(Baseline to 16 Weeks)