NMDA-enhancing Agent for Treatment of Mild Cognitive Impairment and Mild Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
研究概览
简要总结
NMDA activation plays an important role in learning and memory. NMDA receptors were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease and mild cognitive function impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to 2 groups: (1) NMDA enhancer: DAOI-B group (starting dose: 250-500 mg/d); (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI-B may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment or mild 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of mild cognitive impairment or mild Alzheimer's
- •MMSE between 17-26
- •CDR 0.5 or 1
排除标准
- •Hachinski Ischemic Score > 4
- •substance abuse/dependence
- •Parkinson disease
- •major depressive disorder
- •dementia with psychotic features
- •major physical illnesses
- •severe visual or hearing impairment
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
DAOI-B
干预措施: DAOI-B (Drug)
结局指标
主要结局
Change from baseline in Alzheimer's disease assessment scale-cognitive subscale in week 8, 16 and 24
时间窗: Week 0, 8, 16, 24
次要结局
- Change from baseline in Mini Mental Status Examination at week 8, 16 and 24(Week 0, 8, 16, 24)
- Change from baseline in Instrumental Activities of Daily Living at week 8, 16 and 24(Week 0, 8, 16, 24)
- Change from baseline in Verbal learning and memory at week 24(Week 0, 24)
- Change from baseline in Digit Span subtest of the Wechsler Memory Scale at week 24(Week 0, 24)