The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
研究概览
简要总结
Some studies suggest that statin medications may be effective against Alzheimer's disease. However, this has not been proven. The purpose of this study is to evaluate the efficacy of pitavastatin in patients with mild to moderate Alzheimer's disease and hypercholesterolemia.
详细描述
The PIT-ROAD study will include 50 patients who have taken donepezil more than 3 months stably. This study will see how the use of a particular statin medication, pitavastatin, affects ADAS-Jcog score etc. and cholesterol.
Participants will be given a full information of the study and written informed consent should be obtained before entering the study. Participants will take part in 5 visits over the course of 12 months. If participants have taken cholesterol lowering drug, they will have wash-out period at least 4weeks. Participants will undergo 8 tests (ADAS-Jcog etc., baseline and month 12 visits), complete a medical history questionnaire (baseline), complete medication side effect review through questionnaire and/or blood sample (all visits). Participants will be randomly assigned to receive either pitavastatin or other cholesterol lowering medication for 12 months.
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
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alzheimer's Disease patients (15 ≤ MMSE total score ≤ 23, CDR "1" or "2")
- •Patients with hypercholesterolemia
- •Patients who have taken donepezil more than 3 months stably
- •Both patients and care-givers must be more than 20 years old
排除标准
- •Women with pregnancy or breast-feeding
- •Malignant tumor
- •Cerebrovascular disorder or myocardial infarction prior to 12 weeks
- •Heart failure [New York Heart Association (NYHA) class III or IV]
- •Hepatic or renal dysfunction
- •Severe hypertension
- •Hypothyroidism, hereditary muscular disease, history of drug-induced myopathy
- •Current involvement in another investigational drug study
- •Alcoholism, drug abuse
研究组 & 干预措施
1
干预措施: Pitavastatin (Drug)
2
干预措施: cholesterol-lowering medicine other than statin(e.g.,Ezetimibe,Colestimide) (Drug)
结局指标
主要结局
Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)
时间窗: baseline and 12 months
Alzheimer's Disease Assessment Scale-cognitive component-Japanese version is a cognitive test for Alzheimer's disease. This test includes some aspects that assess memory ,orientation, language, praxis, and so on. The possible range of this test is 0-70 points.Higher total points indicate more impairment.
次要结局
- MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)(baseline and 12 months)