Mild Cognitive ImpairmentPhase 4SIMaMCINCT00842920
Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients
A Phase 4 study testing Simvastatin 60 mg and Simvastatin 20 mg in people with Mild Cognitive Impairment, run by Charite University, Berlin, Germany at 13 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Simvastatin 60 mg and Simvastatin 20 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 520 participants
- Where
- 13 sitesGermany
- Study dates
- Dec 2008to 28 Feb 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
Department of Psychiatry and Psychotherapy, Charité-CBF
Berlin
Department of Psychiatry and Psychotherapy, University Bonn
Bonn, 53105
Department of Psychiatry and Psychotherapy, University Erlangen
Erlangen, 91054
Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University
Frankfurt am Main, 60528
Center for Geriatrics and Gerontology, University Freiburg
Freiburg im Breisgau, 79106
Department of Psychiatry and Psychotherapy, Medical University Goettingen
Göttingen, 37075
Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg
Halle, 06112
Department of Psychiatry, University Hospital Heidelberg
Heidelberg, 69115
Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg
Mannheim, 68072
Department of Psychiatry and Psychotherapy, LMU I
Munich, 80336
Institute for Stroke and Dementia Research, LMU
Munich, 81377
Department of Psychiatry and Psychotherapy, University Rostock
Rostock
Neurologische Universitätsklinik Ulm
Ulm, 89081
About this study
Official title: Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
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
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Simvastatin 60 mg, Placebo, Simvastatin 20 mg
- Keywords
- amnestic MCI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 60 mgDrug
60 mg once daily
PlaceboDrug
one tablet once daily
Simvastatin 20 mgDrug
20 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo or 20 mg Simvastatin (stratified by prior use of statins) Receives: Drug: Placebo |
| Simvastatin 60 mg | Experimental | Simvastatin 60 mg once daily Receives: Drug: Simvastatin 60 mg |
| Simvastatin 20 mg | Experimental | Simvastatin 20 mg once daily Receives: Drug: Simvastatin 20 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CDR-SOB at 24 months of treatment
Clinical dementia rating - sum of boxes
Measured: 24 month
Secondary outcomes (3)
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Measured: 24 month
Change in Free and Cued Selective Reminding Test (FCSRT) score
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startDec 2008
- Primary completion31 Aug 2020 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Isabella Heuser, Charite University, Berlin, Germany
- Investigators
- Isabella Heuser, MD, PhD, Principal investigator, Charité-CBFLutz Frölich, MD, Principal investigator, CIMH Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842920
- Sponsor's protocol ID
- EudraCT 2008-002226-11
- Other IDs
- BMBF grant, 01KG0822
- Acronym
- SIMaMCI
- Status last verified
- Jan 2020
- First submitted
- 11 Feb 2009
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Simvastatin in Amnestic MCI Patients
- ClinicalTrials.gov ID
- NCT00842920
- Acronym / sponsor ID
- SIMaMCI / EudraCT 2008-002226-11
- Conditions
- Mild Cognitive Impairment
- Keywords
- amnestic MCI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Dec 2008 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo or 20 mg Simvastatin (stratified by prior use of statins) |
| Simvastatin 60 mg | Experimental | Drug: Simvastatin 60 mgSimvastatin 60 mg once daily |
| Simvastatin 20 mg | Experimental | Drug: Simvastatin 20 mgSimvastatin 20 mg once daily |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 60 mg60 mg once daily | Drug | Simvastatin 60 mg |
| Placeboone tablet once daily | Drug | Placebo |
| Simvastatin 20 mg20 mg once daily | Drug | Simvastatin 20 mg |
Primary outcome
Change in CDR-SOB at 24 months of treatment
Time frame: 24 month
Clinical dementia rating - sum of boxes
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabella Heuser, MD, PhD principal investigator
Charité-CBF
Lutz Frölich, MD principal investigator
CIMH Mannheim
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin 60 mg and Simvastatin 20 mg in people with Mild Cognitive Impairment, run by Charite University, Berlin, Germany at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CDR-SOB at 24 months of treatment (time frame: 24 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.