Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
- Conditions
- F06.7Mild cognitive disorder
- Registration Number
- DRKS00000440
- Lead Sponsor
- Charité Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 640
(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
(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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ength of conversion-free interval, staring at the time of randomization, with conversion being defined as an increase of the CDR score beyond 0.5
- Secondary Outcome Measures
Name Time Method 1. Change in ADAS-cog and FCSRT score; 2. Change in CDR sum of boxes; 3. Change in ADCS-ADL score; 4. Change in volumetric brain measures; 5. Change in CSF and blood measures of ß-amyloid peptides, total and phosphorylized TAU proteins and measures of cerebral cholesterol metabolites; 6. Impact on cost efficacy ratio (ICER); 7. Pharmacogenetic prediction parameters