Efficacy and Safety of Memantine and Sodium Oligomannate in Patients With Moderate to Severe Alzheimer's Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- cognitive function
研究概览
简要总结
Alzheimer's disease (AD) is the main cause of dementia. At present, AD is incurable. Memantine is recommended for the treatment of moderate and severe AD patients. Sodium oligomannate (GV-971) is a marine-derived oligosaccharide. It is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. It reduces Aβ deposition in the brain of Aβ-transgenic mice. The reduction in both Aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. China Food and Drug Administration（CFDA）approved it for the treatment of mild to moderate AD in 2019. Due to the different mechanism of memantine and GV-971, theoretically, they may synergistically improve cognitive function and delay disease progression. However, there is a lack of data on their effectiveness and safety. Therefore, the purpose of this study is to compare the efficacy and safety of memantine and GV-971 monotherapy and combination therapy in patients with moderate to severe AD, which is of great significance for guiding the treatment of moderate and severe AD.
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
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age of 50-80 years old , either sex;
- •met the diagnostic criteria for suspected AD;
- •moderate to severe AD patients(5 points ≤Mini-Mental State Examination total score≤14 points);
- •total Hachinski ischemic scale (HIS) score ≤4 points;
- •memory loss for at least 12 months, with a progressive deterioration;
- •brain MRI scan suggesting a significant possibility of AD;
- •no obvious physical signs during nervous system examination;
- •stable and reliable caregivers;
- •elementary school or higher education level;
- •signed an informed consent form.
排除标准
- •previous nervous system diseases ;
- •mental illness;
- •unstable or severe heart, lung, liver, kidney, or hematopoietic diseases;
- •uncorrectable visual and auditory disorders;
- •simultaneous use of cholinesterase inhibitors, memantine or GV-971.
研究组 & 干预措施
Memantine monotherapy group
Memantine 20mg once-daily
干预措施: Memantine Oral Tablet (Drug)
GV-971 monotherapy group
GV-971 450mg twice a day
干预措施: GV-971 capsule (Drug)
Memantine combined with GV-971 group
Memantine 20mg once-daily plus GV-971 450mg twice a day
干预措施: Memantine Oral Tablet (Drug)
Memantine combined with GV-971 group
Memantine 20mg once-daily plus GV-971 450mg twice a day
干预措施: GV-971 capsule (Drug)
结局指标
主要结局
cognitive function
时间窗: baseline, week 12, week 24, week 36,week 48
the change of Severe Impairment Battery score （The total score ranges from 0 to 100，higher scores mean a better outcome）from baseline at week 48
次要结局
未报告次要终点