A 36-week, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of Sodium Oligomannate (GV-971) in Treatment of Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,312
- 试验地点
- 50
- 主要终点
- Change from baseline in the ADAS-cog/12 score
研究概览
简要总结
The primary purpose of this study is to confirm the clinical efficacy and mechanism of action of GV-971, and identify incidence of known adverse reactions in long-term use and observe new adverse reactions, providing more guidance for clinical use.
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.
- •Hachinski Ischemic Score (HIS) scale total score ≤
- •Hamilton Rating Scale for Depression/17 items (HAMD) total score ≤
- •Brain MRI scan show the highest possibility of AD.
- •Have a reliable study partner/caregiver.
- •Sign the informed consent form.
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 10 minutes of rest.
- •Major medical illness or unstable medical condition within 12 months of screening.
- •Concomitant use of donepezil, rivastigmine, galanthamine, huperzine A, memantine, or aducanumab within 6 moinths prior to baseline.
- •Inadequate hepatic function.
- •Inadequate organ function.
- •ECG clinically significant abnormalities.
研究组 & 干预措施
GV-971
干预措施: GV-971 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the ADAS-cog/12 score
时间窗: Baseline, 36 weeks
Change from baseline in Alzheimer's Disease Assessments Scale - cognitive (ADAS-cog/12) scale total score. The total score of ADAS-cog/12 is 0-75, with higher scores mean a worse outcome.
Change from baseline in ADCS-ADL23 score
时间窗: Baseline, 36 weeks
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living-23-item Scale (ADCS-ADL23) score in moderate AD participants. The total score of ADCS-ADL23 is 0-78, with higher scores mean a better outcome.
次要结局
- Change from baseline in the CIBIC-Plus score(Baseline, 36 weeks)
- Change from baseline in ADCS-ADL23 score(Baseline, 36 weeks)
- Change from baseline in MMSE score(Baseline, 36 weeks)
- Change from baseline in NPI score(Baseline, 36 weeks)