DAOIB for the Treatment of Mild Cognitive Impairment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
研究概览
简要总结
NMDA neurotransmission plays an important role in learning and memory. NMDA receptor-enhancing agent improved the cognitive function of patients with early-phase Alzheimer's disease. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) DAOIB group; (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.
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
- •MMSE between 17-26
排除标准
- •Hachinski Ischemic Score > 4
- •Substance abuse/dependence
- •Parkinson disease, epilepsy, dementia with psychotic features
- •Major psychiatric disorders
- •Major physical illnesses
- •Severe visual or hearing impairment
研究组 & 干预措施
DAOIB
oral, for 24 weeks
干预措施: DAOIB (Drug)
Placebo
oral, for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
时间窗: week 0, 8, 16, 24
Alzheimer's disease assessment scale-cognitive subscale consists of 11 tasks. Its scores range from 0 (best) to 70 (worst).
次要结局
- Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24(week 8, 16, 24)
- Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24(week 0, 8, 16, 24)
- Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24(week 0, 8, 16, 24)
- Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24(week 0, 24)