Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients (SIMaMCI)
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ClinicalTrials.gov Identifier: NCT00842920 |
Recruitment Status : Unknown
Verified January 2020 by Isabella Heuser, Charite University, Berlin, Germany.
Recruitment status was: Active, not recruiting
First Posted : February 12, 2009
Last Update Posted : January 27, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mild Cognitive Impairment | Drug: Simvastatin 60 mg Drug: Placebo Drug: Simvastatin 20 mg | Phase 4 |
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:
- "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.
- "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 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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo or 20 mg Simvastatin (stratified by prior use of statins)
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Drug: Placebo
one tablet once daily |
Experimental: Simvastatin 60 mg
Simvastatin 60 mg once daily
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Drug: Simvastatin 60 mg
60 mg once daily |
Experimental: Simvastatin 20 mg
Simvastatin 20 mg once daily
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Drug: Simvastatin 20 mg
20 mg once daily |
- Change in CDR-SOB at 24 months of treatment [ Time Frame: 24 month ]Clinical dementia rating - sum of boxes
- Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score [ Time Frame: 24 month ]
- Change in Free and Cued Selective Reminding Test (FCSRT) score [ Time Frame: 24 month ]
- 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 ]
- Change in CDR-SOB at Long-Term Follow-Up [ Time Frame: 2-11 years ]

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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 |
Inclusion Criteria:
- 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 Criteria:
- 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

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
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 |
Principal Investigator: | Isabella Heuser, MD, PhD | Charité-CBF | |
Principal Investigator: | Lutz Frölich, MD | CIMH Mannheim |
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 |
amnestic MCI |
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 |