DAOIB Combined With tDCS for Early-phase Dementia - a Randomized, Double-blinded and Placebo Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 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
This is a 24-week randomized, double-blind, placebo-controlled trial. We will enroll patients with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10 sessions in total) during the first 2 weeks of the study, and will also be allocated randomly to either of 2 treatment groups for 24 weeks: (1) DAOIB group; (2) placebo group. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that augmentation with DAOIB will yield better effect than tDCS alone 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
- •Severe visual or hearing impairment
研究组 & 干预措施
tDCS+DAOIB
干预措施: DAOIB (Drug)
tDCS+DAOIB
干预措施: tDCS (Device)
tDCS+placebo
干预措施: Placebo (Drug)
tDCS+placebo
干预措施: tDCS (Device)
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 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 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 Quality of life 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)