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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Isabella Heuser, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00842920
First received: February 11, 2009
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Simvastatin significantly reduces the risk of conversion to Alzheimer's disease in individuals with MCI as compared to MCI receiving placebo.


Condition Intervention Phase
Mild Cognitive Impairment
Drug: Simvastatin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Length of conversion-free interval, starting at the time of randomization, with conversion being defined as an increase of the Clinical Dementia Rating (CDR) score beyond 0.5 [ Time Frame: 48 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Free and Cued Selective Reminding Test (FCSRT) score [ Time Frame: 48 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 445
Study Start Date: December 2008
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
one tablet once daily
Experimental: Simvastatin
Simvastatin 60 mg once daily
Drug: Simvastatin
60 mg once daily

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. Subjects will be randomly assigned to one of 2 treatment arms: (1) Simvastatin (60 mg) one tablet/day (2) Placebo one tablet/day.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842920

Locations
Germany
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 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, 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, University Duisburg-Essen Recruiting
Essen, Germany, 45147
Contact: vacant    vacant      
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 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 Neurology, LMU II, University Munich-Grosshadern Recruiting
Munich, Germany, 81377
Contact: Nibal Ackl, MD       Nibal.Ackl@med.uni-muenchen.de   
Principal Investigator: Nibal Ackl, 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

No publications provided

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
Study First Received: February 11, 2009
Last Updated: July 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Cognition Disorders
Mild Cognitive Impairment
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014