Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients

Charité - Unversitätsmedizin Berlin0 个研究点目标入组 520 人开始时间: 2008年9月3日最近更新: 2020年11月3日

适应症

试验速览

暂无简介。

•(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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 370

•(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 or myocardial infarction
•(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; co-medication of statins in high doses; low doses equivalent to 20 mg Simvastatin are allowed if taken for max. 2 years before randomization
•(9) Persons who are detained officially or legally to an official institute

发起方

Charité - Unversitätsmedizin Berlin