DAOIB for the Treatment of Cognitive Function and Behavioral and Psychological Symptoms of Dementia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Behavioral Pathology in Alzheimer's Disease Rating Scale
研究概览
简要总结
The population of dementia is increasing rapidly. Cognitive impairment as well as Behavioral and psychological symptoms of dementia (BPSD) add heavy burdens to caregiver. NMDA activation is critical for learning and memory. Individuals with Alzheimer's disease (AD) have fewer NMDA receptors in the frontal cortex and hippocampus than controls. This study is a randomized, double-blind, placebo-controlled drug trial. All patients will be allocated randomly to two groups: (1) NMDA enhancer: DAOIB (starting dosage: 250-500 mg/day), (2) placebo, for 6 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function and clinical symptoms in patients with BPSD.
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 probable Alzheimer's disease or probable vascular dementia
- •For patients with vascular dementia, the post-stroke period must be more than 3 months
- •Mini-Mental State scores between 5-26
- •Clinical Dementia Rating score equal to or greater than 1
- •Behavioral Pathology in Alzheimer's Disease Rating Scale score equal to or greater than 2
排除标准
- •Current substance abuse or history of substance dependence in the past 6 months
- •Other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc.
- •Serious medical or neurological illness other than Alzheimer's disease/vascular dementia and other secondary dementia
研究组 & 干预措施
DAOIB
Drug: DAOIB 250-1500 mg/day by mouth for 6 weeks
干预措施: DAOIB (Drug)
Placebo
Placebo by mouth per day for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Behavioral Pathology in Alzheimer's Disease Rating Scale
时间窗: weeks 0, 2, 4, 6
Change from baseline in Behavioral Pathology in Alzheimer's Disease Rating Scale at weeks 2, 4 and 6
Alzheimer's Disease Assessment Scale - cognitive subscale
时间窗: weeks 0 and 6
Change from baseline in Alzheimer's Disease Assessment Scale - cognitive subscale at week 6
次要结局
- Neuropsychiatirc Inventory(weeks 0 and 6)
- Instrumental Activities of Daily Living(weeks 0 and 6)
- Zarit Caregiver Burden Interview(weeks 0 and 6)
- Geriatric Geriatric Depression Scale(weeks 0, 2, 4, 6)
- Mini-Mental Status Examination(weeks 0 and 6)
研究者
Chieh-Hsin Lin
Dr
Chang Gung Memorial Hospital