A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy and Safety of 26-Week Treatment of AR1001 in Patients With Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 20
- 主要终点
- ADAS-Cog 13
研究概览
简要总结
A double-blinded, randomized, placebo-controlled study will be performed to evaluate the efficacy and safety of treating AR1001 in patients with mild to moderate Alzheimer's disease for 26 weeks.
详细描述
Alzheimer's Disease (AD) is the most prevalent neurodegenerative disorder in The United States affecting approximately 5.4 million Americans. AD is characterized by progressive loss in memory and as well as a decline in the ability to learn that is associated with neuronal death. Well known hallmarks of AD are neuritic plaques and neurofibrillary tangles and extensive inflammation. Currently, no treatment has been developed to fully cure or prevent the progression of dementia that is associated with AD.
AR1001 is a polypharmacological drug candidate being developed as a treatment for AD and shows great potential with favorable attributes for a central nervous system (CNS) drug (i.e., high specificity and potency, as well as good pharmacokinetic, bioavailability, CNS penetration, and ensured safety).
The clinical study of AR1001 aims to evaluate the efficacy and safety of AR1001 as a potential treatment for AD. Based on the preclinical results, AR1001 could be an effective treatment option with a mechanism of action that has not been explored for AD indication.
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)
盲法说明
Double-blind for study site and participants
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo, orally administered once daily for 26 weeks.
干预措施: Placebo (Drug)
AR1001 - 10 mg
Active, AR1001 - 10 mg, orally administered once daily for 26 weeks.
干预措施: AR1001 (Drug)
AR1001 - 30 mg
Active, AR1001 - 30 mg, orally administered once daily for 26 weeks.
干预措施: AR1001 (Drug)
结局指标
主要结局
ADAS-Cog 13
时间窗: 26 weeks
Change of ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale) from baseline at Week 26
ADCS-CGIC
时间窗: 26 weeks
Change of ADCS-CGIC (Alzheimer's disease Cooperative Study-Clinical Global Impression of Change)
次要结局
- NPI(26 weeks)
- GDS(26 weeks)
- QOL-AD(26 weeks)
- C-SSRS(26 weeks)
- Treatment related adverse events(26 weeks)
- MMSE-2(26 weeks)