NCT00842920Unknown4 期
Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 520
- 试验地点
- 13
- 主要终点
- Change in CDR-SOB at 24 months of treatment
研究概览
简要总结
Probands with MCI are at high risk to develop Alzheimer´s dementia (AD). Simvastatin may lower the production of Amyloid, a hallmark of AD in the brain. The primary hypothesis of the study is that 60 mg Simvastatin significantly reduces the Clinical Dementia Rating -Sum of boxes (CDR-SOB) in individuals with MCI as compared to MCI receiving placebo or 20 mg Simvastatin
详细描述
This is a national multicenter, double-blind, randomized placebo-controlled trial allowing for a minimum follow-up time of 24 months in conversion-free patients. Randomization will be stratified by prior use of statins.
The two strata are:
- "no-statins": patients without treatment with a statins and no indication for treatment (according to the guidelines of the German Society of Cardiology for the primary prevention of cardiovascular disease); patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) Placebo one tablet/day.
- "low-statins": patients treated with low doses of Statins; patients will be randomly assigned to one of 2 treatment (1) Simvastatin (60 mg) one tablet/day (2) 20 mg Simvastatin one tablet/day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Self and informant report of gradually increasing memory impairment for at least six months.
- •Objective memory impairment
- •Intact basic activities of daily living
- •Preserved general cognitive function, not demented
- •Absence of a detectable cause of memory disorder
- •Females without childbearing potential
- •A total cholesterol ≥90 mg/dl
- •LDL-cholesterol ≥ 160 mg/dl and ≤ 3 risk factors or ≥ 190 mg/dl and ≤ 2 risk factors including age
- •Informed consent (according german medicinal products act, AMG §40 (1) 3b)
- •No participation in other clinical trials 2 months before and after participation in this study
- •Probands should only recruited for the clinical trial, when they are able to perform the informed consent; due to worsening of "memory function" in the course of the clinical trial, probands should not longer participate the clinical trial, when they is evidence, that participants were not longer able to give full informed consent.
排除标准
- •Hypersensitivity against Simvastatin, active liver disease or lasting increase of serum transaminases for unclear reason
- •Unstable medical, neurological or psychiatric disease
- •Lack of a spouse or a close relative
- •Use of a registered anti-dementia drug or a nootropic
- •Chronic use of anti-inflammatory drugs
- •History of stroke or myocardial infarction
- •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
- •Comedication with Diltiazem, Verapamil, Amiodarone, Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, Ciclosporin, Gemfibrozil, Nefazodone, HIV-protease inhibitors, Benzodiazepines, Tricyclic antipsychotics or other anticholinergic drugs
- •Comedication of other statins in high doses; low doses equivalent to 20 mg Simvastatin are allowed if taken for max. 2 years before randomization
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo or 20 mg Simvastatin (stratified by prior use of statins)
干预措施: Placebo (Drug)
Simvastatin 60 mg
Experimental
Simvastatin 60 mg once daily
干预措施: Simvastatin 60 mg (Drug)
Simvastatin 20 mg
Experimental
Simvastatin 20 mg once daily
干预措施: Simvastatin 20 mg (Drug)
结局指标
主要结局
Change in CDR-SOB at 24 months of treatment
时间窗: 24 month
Clinical dementia rating - sum of boxes
次要结局
- Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score(24 month)
- Change in Free and Cued Selective Reminding Test (FCSRT) score(24 month)
- Length of conversion-free interval, starting at the time of randomization, with conversion being defined as an increase of the CDR score beyond 0.5(24 months)
研究者
Isabella Heuser
Prof. Dr.
Charite University, Berlin, Germany
研究点 (13)
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SIMaMCI: Prevention of Alzheimer´s dementia by administration of simvastatiAmnestic mild cognitive impairment (MCI) denotes clinical conditions in the border zone between normal cognitive functioning and dementia. The definition of amnestic MCI by Petersen and his co-workers is an attempt to focus on those MCI patients who are at greatest risk to develop Alzheimer´s disease. There has to be subjective and objective memory impairment, but general cognitive function and activities of daily living must be essentially intact.EUCTR2008-002226-11-DECharité - Unversitätsmedizin Berlin520