A Clinical Study to Evaluate the Long-term Efficacy and Safety of Sodium Oligomannate Capsules (GV-971)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
- 试验地点
- 40
- 主要终点
- Change from baseline in the ADAS-cog/11 score
研究概览
简要总结
Sodium Oligomannate Capsules (GV-971) has been approved for treatment of mild to moderate Alzheimer's disease and improving the cognitive function of patients. This study plans to observe, in the clinical patients, the long-term efficacy and safety of GV-971, as well as the changes in blood and gut microbiota biomarkers after treatment, to validate the mechanism of action of GV-971, in order to better guide the rational use of drug in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Aged 50 to 85 years (inclusive), with no restriction on gender;
- •Patients who met criteria for "probable AD" by National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria;
- •Patients with mild to moderate AD as characterized by Mini-Mental State Examination (MMSE) scores between 11 and 26, inclusive;
- •Patients who have received at least primary education and have capacity to complete the measurement of cognition and other tests as specified in the protocol;
- •Patients receiving GV-971 treatment prescribed by clinicians;
- •Sign the informed consent form.
排除标准
- •Patients who have received GV-971 treatment within 6 months prior to screening;
- •Patients who may be allergic to Sodium Oligomannate Capsules as judged by the investigator;
- •Female participants who are pregnant or lactating;
- •Patients who cannot cooperate to complete the follow-up inquiries;
- •Any other diseases or conditions that are inappropriate to participate in this clinical trial in the opinion of the investigator.
研究组 & 干预措施
Sodium Oligomannate Capsules (GV-971)
The recommended dose regimen for subjects: GV-971 450 mg (3 capsules) per dose, bid, po. in morning and evening
干预措施: Sodium Oligomannate Capsules (GV-971) (Drug)
结局指标
主要结局
Change from baseline in the ADAS-cog/11 score
时间窗: Baseline, 48 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
- Change from baseline in MMSE score(Baseline, 48 weeks, 96 weeks)
- Change from baseline in ADAS-Cog/11 score(Baseline, 96 weeks)
- Change from baseline in ADCS-ADL score(Baseline, 48 weeks, 96 weeks)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(48 weeks, 96 weeks)