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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 : Active, not recruiting
First Posted : February 12, 2009
Last Update Posted : January 27, 2020
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 60 mg Drug: Placebo Drug: Simvastatin 20 mg 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
Actual Study Start Date : December 2008
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

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 60 mg
Simvastatin 60 mg once daily
 Drug: Simvastatin 60 mg
60 mg once daily
Experimental: Simvastatin 20 mg
Simvastatin 20 mg once daily
 Drug: Simvastatin 20 mg
20 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 ]

Other Outcome Measures:
  1. Change in CDR-SOB at Long-Term Follow-Up [ Time Frame: 2-11 years ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
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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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
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Germany
Department of Psychiatry and Psychotherapy, Charité-CBF
Berlin, Germany
Department of Psychiatry and Psychotherapy, University Bonn
Bonn, Germany, 53105
Department of Psychiatry and Psychotherapy, University Erlangen
Erlangen, Germany, 91054
Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany, 60528
Center for Geriatrics and Gerontology, University Freiburg
Freiburg, Germany, 79106
Department of Psychiatry and Psychotherapy, Medical University Goettingen
Göttingen, Germany, 37075
Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg
Halle, Germany, 06112
Department of Psychiatry, University Hospital Heidelberg
Heidelberg, Germany, 69115
Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg
Mannheim, Germany, 68072
Department of Psychiatry and Psychotherapy, LMU I
Munich, Germany, 80336
Institute for Stroke and Dementia Research, LMU
Munich, Germany, 81377
Department of Psychiatry and Psychotherapy, University Rostock
Rostock, Germany
Neurologische Universitätsklinik Ulm
Ulm, Germany, 89081
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
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Principal Investigator: Isabella Heuser, MD, PhD Charité-CBF
Principal Investigator: Lutz Frölich, MD CIMH Mannheim
More Information
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Responsible Party: Isabella Heuser, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00842920    
Other Study ID Numbers: EudraCT 2008-002226-11
BMBF grant, 01KG0822
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Keywords provided by Isabella Heuser, Charite University, Berlin, Germany:
amnestic MCI
Additional relevant MeSH terms:
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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