NCT03363269已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Evaluate the Efficacy and Safety of ID1201 for Dose-finding in Mild Alzheimer's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 20
- 主要终点
- Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of ID1201 in patients with mild Alzheimer's disease
详细描述
ID1201 is a fruit extract of Melia toosendan. ID1201 alleviates Alzheimer's disease-type pathologies and cognitive deficit through the various actions of its effective components such as α-secretase activation followed to Aβ reduction, RAGE inhibition, neuro-protection, and anti-inflammatory activities.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with dementia of Alzheimer's type according to DSM-IV criteria and probable Alzheimer's disease according to the NINCDS-ADRDA
- •modified Hachinski Ischemia Scale score of less than or equal to 4
- •Mini-Mental State Examination score 16 to 26 and Clinical Dementia Rating-Global Scale score 0.5 to 1
- •Amyloid postivie PET image (BAPL score 2 or 3)
- •Patients who have not received AChE inhibitors or NMDA antagonist at least for 3 months prior to the screening visit
排除标准
- •Patients diagnosed or accompanied with Dementia due to other Neurodegenerative disorders other than Alzheimer's disease
- •Chronic alcohol and/or drug abuse within the past 5 years
- •Subjects who have medical history of significant renal disease (ccr<30ml/min) or hepatic disease( 3*ULN <= ALT or AST)
- •Has received choline agonists, anticholinergics, anticonvulsants, antidepressants, antipsychotic drugs, Ginko biloba extract, Vitamin E, hormone replacement therapy etc. in the previous 4 weeks
研究组 & 干预措施
ID1201 100mg
Experimental
干预措施: ID1201 (Drug)
ID1201 200mg
Experimental
干预措施: ID1201 (Drug)
ID1201 400mg
Experimental
干预措施: ID1201 (Drug)
Placebo
Placebo Comparator
干预措施: ID1201 (Drug)
结局指标
主要结局
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at 12 Weeks
时间窗: Baseline, 12 weeks
次要结局
未报告次要终点
研究者
研究点 (20)
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