NMDA Enhancer for the Treatment of Mild Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 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 receptors (NMDAR) were found to decrease in the frontal lobe and hippocampus of Alzheimer's disease (AD). This study is a randomized, double-blind, placebo controlled drug trial for testing the efficacy of NMDAR-enhancer. All subjects will be allocated randomly to 4 groups: (1) DAOI-A group; (2) DAOI-B group; (3) DAOI-C group; (4) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOI may yield better efficacy than placebo for cognitive function in patients with 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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Alzheimer's disease
- •MMSE between 10-26
排除标准
- •Hachinski Ischemic Score > 4
- •Substance abuse/dependence
- •Parkinson disease, epilepsy, dementia with psychotic features
- •Major depressive disorder
- •Major physical illnesses
- •Severe visual or hearing impairment
研究组 & 干预措施
DAOI-C group
干预措施: DAOI-C group (Drug)
Placebo group
干预措施: Placebo oral capsule (Drug)
DAOI-A group
干预措施: DAOI-A group (Drug)
DAOI-B group
干预措施: DAOI-B group (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
Cognitive assessment
次要结局
- Change from baseline in speed of processing (Category Fluency) at week 24(week 0, 24)
- Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24(week 0, 24)
- Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input at week 8, 16 and 24(week 8, 16, 24)
- Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24(week 0, 24)