NMDA Enhancement Combined With Omega-3 Fatty Acids for the Treatment of Early Dementia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 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
In this 4-year proposed project, we will enroll 140 patients with aMCI or mild AD into a 24-week randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to one of two treatment groups for 24 weeks (n = 70 in each group) in a double-blind manner: [1] DAOIB + omega-3; [2] DAOIB + placebo. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB combined with omega-3 will yield better efficacy than placebo in improving the cognitive function, global functioning and quality of life in patients with aMCI or mild 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
- Quadruple (Participant, Care Provider, Investigator, 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 or mild cognitive impairment
- •MMSE between 10-26
- •CDR 1 or 0.5
排除标准
- •Hachinski Ischemic Score > 4
- •Substance abuse/dependence
- •Parkinson disease, epilepsy, dementia with psychotic features
- •Major depressive disorder
- •Major physical illnesses
- •memantine or special omega-3 fatty acids therapy within 3 months before enrollment
- •Severe visual or hearing impairment
研究组 & 干预措施
DAOIB+Omega-3
干预措施: DAOIB+Omega-3 (Drug)
DAOIB+Placebo
干预措施: DAOIB+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 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 Mini-Mental Status examination 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 24(week 0, 24)
- Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) at week 8, 16 and 24(week 0, 8, 16, 24)
- Change from baseline in Quality of life score at week 8, 16 and 24(week 0, 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)