Status:
UNKNOWN
Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
German Federal Ministry of Education and Research
Conditions:
Mild Cognitive Impairment
Eligibility:
All Genders
55-90 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
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 pr...
Eligibility Criteria
Inclusion
- 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
- Age 55 to 90.
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00842920
Start Date
December 1 2008
End Date
February 28 2021
Last Update
January 27 2020
Active Locations (13)
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1
Department of Psychiatry and Psychotherapy, Charité-CBF
Berlin, Germany
2
Department of Psychiatry and Psychotherapy, University Bonn
Bonn, Germany, 53105
3
Department of Psychiatry and Psychotherapy, University Erlangen
Erlangen, Germany, 91054
4
Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, 60528