Back to resultsTrial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients (SIMaMCI)
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Simvastatin 60 mg
Placebo
Simvastatin 20 mg
Sponsored by
About this trial
This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring amnestic MCI
Eligibility Criteria
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
Sites / Locations
- Department of Psychiatry and Psychotherapy, Charité-CBF
- Department of Psychiatry and Psychotherapy, University Bonn
- Department of Psychiatry and Psychotherapy, University Erlangen
- Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University
- Center for Geriatrics and Gerontology, University Freiburg
- Department of Psychiatry and Psychotherapy, Medical University Goettingen
- Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg
- Department of Psychiatry, University Hospital Heidelberg
- Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg
- Department of Psychiatry and Psychotherapy, LMU I
- Institute for Stroke and Dementia Research, LMU
- Department of Psychiatry and Psychotherapy, University Rostock
- Neurologische Universitätsklinik Ulm
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Simvastatin 60 mg
Simvastatin 20 mg
Arm Description
Placebo or 20 mg Simvastatin (stratified by prior use of statins)
Simvastatin 60 mg once daily
Simvastatin 20 mg once daily
Outcomes
Primary Outcome Measures
Change in CDR-SOB at 24 months of treatment
Clinical dementia rating - sum of boxes
Secondary Outcome Measures
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Change in Free and Cued Selective Reminding Test (FCSRT) score
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
Full Information
NCT ID
NCT00842920
First Posted
February 11, 2009
Last Updated
January 22, 2020
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00842920
Brief Title
Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients
Acronym
SIMaMCI
Official Title
Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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:
"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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
amnestic MCI
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo or 20 mg Simvastatin (stratified by prior use of statins)
Arm Title
Simvastatin 60 mg
Arm Type
Experimental
Arm Description
Simvastatin 60 mg once daily
Arm Title
Simvastatin 20 mg
Arm Type
Experimental
Arm Description
Simvastatin 20 mg once daily
Intervention Type
Drug
Intervention Name(s)
Simvastatin 60 mg
Intervention Description
60 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one tablet once daily
Intervention Type
Drug
Intervention Name(s)
Simvastatin 20 mg
Intervention Description
20 mg once daily
Primary Outcome Measure Information:
Title
Change in CDR-SOB at 24 months of treatment
Description
Clinical dementia rating - sum of boxes
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Time Frame
24 month
Title
Change in Free and Cued Selective Reminding Test (FCSRT) score
Time Frame
24 month
Title
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 Pre-specified Outcome Measures:
Title
Change in CDR-SOB at Long-Term Follow-Up
Time Frame
2-11 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabella Heuser, MD, PhD
Organizational Affiliation
Charité-CBF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lutz Frölich, MD
Organizational Affiliation
CIMH Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Charité-CBF
City
Berlin
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, University Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, University Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
Facility Name
Center for Geriatrics and Gerontology, University Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, Medical University Goettingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg
City
Halle
ZIP/Postal Code
06112
Country
Germany
Facility Name
Department of Psychiatry, University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg
City
Mannheim
ZIP/Postal Code
68072
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, LMU I
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Institute for Stroke and Dementia Research, LMU
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, University Rostock
City
Rostock
Country
Germany
Facility Name
Neurologische Universitätsklinik Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients
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