Effect of Astaxanthin on the Patients With Alzheimer Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Mini-Mental State Examination (MMSE)
研究概览
简要总结
This study adapts a randomized, double-blind, placebo-controlled trial, to exam the possible benefit of Astaxanthin on Alzheimer disease. The enrolled Alzheimer patients will take Astaxanthin or placebo for 1 year. We will follow up Mini-Mental State Examination, Cognitive Ability Screening Instrument, Clinical Dementia Rating, and Neuropsychiatric Inventory at the end of the study.
详细描述
This study aims to examine the benefit of Astaxanthin as adjuvant therapy for Alzheimer's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 ≦ age ≦ 90
- •Clinical Dementia Rating Scale = 0.5 or 1
- •Under treatment with donepezil、rivastigmine or galantamine with good medical adherence
- •Get a signed informed consent from the patient or his/her family
排除标准
- •Not using or poor medical adherence to donepezil、rivastigmine or galantamine
- •Combined using memantine or other cerebral perfusion enhancing agent, such as Piracetam, Dihydroergotoxine, Nicergoline etc.
- •New cerebrovascular disease happens during 3-year follow up
- •Mixed type dementia
- •Major psychiatric disease (such as depression, bipolar disorder, schizophrenia) or substance abuser (such as alcohol, illegal drug, hypnotics)
- •Heart failure, end stage renal disease, liver cirrhosis, or other major organ failure
- •Severe hearing impairment results in incomplete survey of neuropsychatric evaluation
- •No informed consent or no regular follow up
结局指标
主要结局
Mini-Mental State Examination (MMSE)
时间窗: 3 years
All participants receive MMSE when they are enrolled, and follow up annually for a total of 3 years.
Neuropsychiatric Inventory (NPI)
时间窗: 3 years
All participants receive NPI when they are enrolled, and follow up annually for a total of 3 years.
Cognitive Ability Screening Instrument (CASI)
时间窗: 3 years
All participants receive CASI when they are enrolled, and follow up annually for a total of 3 years.
Clinical Dementia Rating (CDR)
时间窗: 3 years
All participants receive CDR when they are enrolled, and follow up annually for a total of 3 years.
次要结局
- Incidence of treatment-emergent adverse events [safety and tolerability](3 years)