NMDA-enhancing Agent 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
- 24
- 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 were found to decrease in the frontal lobe and hippocampus of mild cognitive impairment. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) NMDA-enhancer: DAOIB group (starting dose: 250-500 mg/d); (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
- Triple (Participant, Care Provider, Investigator)
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 depressive disorder
- •Major physical illnesses
- •Severe visual or hearing impairment
研究组 & 干预措施
DAOIB
250-1500 mg/day, oral, for 24 weeks
干预措施: DAOIB (Drug)
Placebo
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
次要结局
- Change from baseline in verbal learning and memory tests (Wechsler Memory Scale, Word Listing) at week 24(week 0, 24)
- Change from baseline in working memory (Wechsler Memory Scale, Spatial Span) at week 24(week 0, 24)
- Change from baseline in speed of processing (Category Fluency) 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)
研究者
Chieh-Hsin Lin
Dr
Chang Gung Memorial Hospital