NCT04520412暂停3 期
A Phase 3, Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease (GREEN MEMORY: GREen Valley 971 EvaluatioN Memory)
Green Valley (Shanghai) Pharmaceuticals Co., Ltd.168 个研究点 分布在 1 个国家目标入组 2,046 人开始时间: 2020年10月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 2,046
- 试验地点
- 168
- 主要终点
- Change from baseline in the ADCS-CGIC score
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate AD per NIA-AA.
- •History of cognitive and functional decline over at least 1 year.
- •MMSE scores between 11 and 24 (inclusive) at baseline.
- •Brain MRI scan show the highest possibility of AD.
- •Have a study partner/caregiver.
排除标准
- •Diagnosis of a dementia-related central nervous system disease other than AD.
- •Major structural brain disease as judged by MRI.
- •A resting heart rate of < 50 beats per minute (bpm) after 5 minutes of rest in sitting or supine position.
- •Major medical illness or unstable medical condition within 6 months of screening.
- •Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, and during the study.
- •Inadequate hepatic function.
- •Inadequate organ and marrow function.
- •ECG clinically significant abnormalities.
研究组 & 干预措施
GV-971
Experimental
干预措施: GV-971 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the ADCS-CGIC score
时间窗: Baseline, 48 weeks and 52 weeks
Change from baseline on Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) scale total score. The total score of ADCS-CGIC is 1-7, with higher scores mean a worse outcome.
Change from baseline in the ADAS-cog/11 score
时间窗: Baseline, 48 weeks and 52 weeks
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/11) scale total score. The total score of ADAS-cog/11 is 0-70, with higher scores mean a worse outcome.
次要结局
- Assess the efficacy of GV-971 throughout the OLE period(Baseline, 52 Weeks, 78 Weeks)
- Change from baseline in NPI score(Baseline, 36 Weeks, 52 Weeks)
- Change from baseline in MMSE score(Baseline, 52 Weeks)
- Change from baseline in ADCS-ADL23 score(Baseline, 36 Weeks, 52 Weeks)
- Change from baseline in NPI caregiver items(Baseline, 52 Weeks)
- Change from baseline in ZBI score(Baseline, 52 Weeks)
研究者
研究点 (168)
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