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Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients (SIMaMCI)

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ClinicalTrials.gov Identifier: NCT00842920
Recruitment Status : Recruiting
First Posted : February 12, 2009
Last Update Posted : September 16, 2015
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Isabella Heuser, Charite University, Berlin, Germany

Study Description
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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 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

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Simvastatin Drug: Placebo Phase 4

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 prior use of statins.

The two strata are:

  1. "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.
  2. "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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
Study Start Date : December 2008
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo or 20 mg Simvastatin (stratified by prior use of statins)
 Drug: Placebo
one tablet once daily
Experimental: Simvastatin
Simvastatin 60 mg once daily
 Drug: Simvastatin
60 mg once daily


Outcome Measures
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Primary Outcome Measures :
  1. Change in CDR-SOB at 24 months of treatment [ Time Frame: 24 month ]
    Clinical dementia rating - sum of boxes


Secondary Outcome Measures :
  1. Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score [ Time Frame: 24 month ]
  2. Change in Free and Cued Selective Reminding Test (FCSRT) score [ Time Frame: 24 month ]
  3. 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 [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 90.
  7. Females without childbearing potential
  8. A total cholesterol ≥90 mg/dl
  9. LDL-cholesterol ≥ 160 mg/dl and ≤ 3 risk factors or ≥ 190 mg/dl and ≤ 2 risk factors including age
  10. Informed consent (according german medicinal products act, AMG §40 (1) 3b)
  11. No participation in other clinical trials 2 months before and after participation in this study
  12. 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 Criteria:

  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.
  8. LDL-cholesterol >190 mg/dl
  9. Comedication with Diltiazem, Verapamil, Amiodarone, Itraconazole, Ketoconazole, Erythromycin, Clarithromycin, Telithromycin, Ciclosporin, Gemfibrozil, Nefazodone, HIV-protease inhibitors, Benzodiazepines, Tricyclic antipsychotics or other anticholinergic drugs
  10. Comedication of other statins in high doses; low doses equivalent to 20 mg Simvastatin are allowed if taken for max. 2 years before randomization
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842920


Locations
Germany
Department of Neurology, Charité-CBF Recruiting
Berlin, Germany, 12200
Contact: Joachim Weber, MD    +49308445 ext 4705    joachim.weber@charite.de   
Principal Investigator: Joachim Weber, MD         
Department of Psychiatry and Psychotherapy, Charité-CBF Recruiting
Berlin, Germany
Contact: Oliver Peters, MD    +49-30-8445-8215    oliver.peters@charite.de   
Sub-Investigator: Oliver Peters, MD         
Principal Investigator: Isabella Heuser, MD         
Department of Psychiatry and Psychotherapy, University Bonn Recruiting
Bonn, Germany, 53105
Contact: Wolfgang Maier, Prof       w.maier@uni-bonn.de   
Principal Investigator: Wolfgang Maier, MD         
Department of Psychiatry and Psychotherapy, University Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Kornhuber Johannes, MD    09131/85 ext 34166    johanneskornhuber@uk-erlangen.de   
Principal Investigator: Johannes Kornhuber, MD         
Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University Recruiting
Frankfurt am Main, Germany, 60528
Contact: Tarik Karakaya, MD    +49 69 6301 ext 5259    tarik.karakaya@kgu.de   
Principal Investigator: Tarik Karakaya, MD         
Center for Geriatrics and Gerontology, University Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Stefan Klöppel, MD       stefan.kloeppel@uniklinik-freiburg.de   
Principal Investigator: Stefan Klöppel, MD         
Department of Psychiatry and Psychotherapy, Medical University Goettingen Recruiting
Goettingen, Germany, 37075
Contact: Anja Schneider, MD    0551-3914258    aschnei8@gwdg.de   
Principal Investigator: Anja Schneider, MD         
Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg Active, not recruiting
Halle, Germany, 06112
Department of Psychiatry, University Hospital Heidelberg Recruiting
Heidelberg, Germany, 69115
Contact: Johannes Schröder, MD       johannes_schroeder@med.uni-heidelberg.de   
Principal Investigator: Johannes Schröder, MD         
Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg Recruiting
Mannheim, Germany, 68072
Contact: Lutz Fröhlich, MD    +49 621 1703 ext 3001    lutz.froelich@zi-mannheim.de   
Principal Investigator: Lutz Fröhlich, MD         
Department of Neurology, Philipps University Marburg Recruiting
Marburg, Germany, 35032
Contact: Richard Dodel, MD       richard.dodel@staff.uni-marburg.de   
Principal Investigator: Richard Dodel, MD         
Department of Psychiatry and Psychotherapy, LMU I Recruiting
Munich, Germany, 80336
Contact: Eva Meisenzahl, MD    089-5160 ext 5772    eva.meisenzahl@med.uni-muenchen.de   
Principal Investigator: Eva Meisenzahl, MD         
Institute for Stroke and Dementia Research, LMU Recruiting
Munich, Germany, 81377
Contact: Katharina Bürger, MD    +49-89-7095 ext 8330    katharina.buerger@med.uni-muenchen.de   
Principal Investigator: Katharina Bürger, MD         
Department of Psychiatry and Psychotherapy, University Rostock Recruiting
Rostock, Germany
Contact: Stefan Teipel, MD    +49-381-494-9610    stefan.teipel@med.uni-rostock.de   
Principal Investigator: Stefan Teipel, MD         
Neurologische Universitätsklinik Ulm Recruiting
Ulm, Germany, 89081
Contact: Christine von Arnim, MD    +49-731- ext 177-5201    christine.arnim@uni-ulm.de   
Principal Investigator: Christine von Arnim, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Isabella Heuser, MD, PhD Charité-CBF
Principal Investigator: Lutz Frölich, MD CIMH Mannheim
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Isabella Heuser, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00842920     History of Changes
Other Study ID Numbers: EudraCT 2008-002226-11
BMBF grant, 01KG0822
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015

Keywords provided by Isabella Heuser, Charite University, Berlin, Germany:
amnestic MCI

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Simvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors