DRKS00000440招募中4 期
Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 640
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 55 Years 至 85 Years（—）
- 性别
- All
入选标准
- •(1) Self and informant report of gradually increasing memory impairment for at least six months.
- •(2) Objective memory impairment
- •(3) Intact basic activities of daily living
- •(4) Preserved general cognitive function, not demented
- •(5) Absence of a detectable cause of memory disorder
- •(6) Age 55 to 85.
- •(7) Females without childbearing potential
- •(8) A total cholesterol =90 mg/dl
- •(9) LDL-cholesterol <130 mg/dl. LDL-cholesterol 130-160 mg/dl = 3 risk factors including age or 160-190 mg/dl and 2 risk factors (only controlled hypertension and age)
- •(10) Informed consent (according AMG §40 (1) 3b)
- •(11) No participation in other clinical trials 2 months before and
- •after participation in this study
排除标准
- •(1) Hypersensitivity against Simvastatin, active liver disease or
- •lasting increase of serum transaminases for unclear reason
- •(2) Unstable medical, neurological or psychiatric disease
- •(3) Lack of a spouse or a close relative
- •(4) Use of a registered anti-dementia drug or a nootropic
- •(5) Chronic use of anti-inflammatory drugs
- •(6) History of stroke, coronary heart disease or myocardial infarction. Severe renal insuffiency.
- •(7) LDL-cholesterol 130-160 mg/dl and > 3 risk factors or 160-190 mg/dl and > 2 risk factors including age. LDL-cholesterol >190 mg/dl
- •(8) Comedication with Diltiazem, Verapamil, Amiodaron, Itraconazol, Ketokonazol, Erythromycin,Clarithromycin, Telithromycin, Ciclosporin, Gemfibrozil,Nefazodon, HIV-protease inhibitors, Benzodiazepines,
- •Tricyclic antipsychotics or other anticholinergic drugs;Comedication of other statins.
- •(9) Persons who are detained officially or legally to an official institute
研究者
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