CClinicalTrials.gg
Sign In
Status unknownNCT00842920SIMaMCIUpdated Jan 27, 2020

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

A Phase 4 interventional study of Simvastatin 60 mg and Placebo in Mild Cognitive Impairment, sponsored by Charite University, Berlin, Germany. Status unknown at 13 sites in Germany. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
All
01

Study 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

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:

  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.
02

Conditions studied

  • Mild Cognitive Impairment

Keywords

  • amnestic MCI
03

In context

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 520 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
520 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo or 20 mg Simvastatin (stratified by prior use of statins)

    Drug: Placebo

  • Experimental
    Simvastatin 60 mg

    Simvastatin 60 mg once daily

    Drug: Simvastatin 60 mg

  • Experimental
    Simvastatin 20 mg

    Simvastatin 20 mg once daily

    Drug: Simvastatin 20 mg

Interventions

  • DrugSimvastatin 60 mg

    60 mg once daily

  • DrugPlacebo

    one tablet once daily

  • DrugSimvastatin 20 mg

    20 mg once daily

06

What researchers measure

Primary outcomes

  1. Change in CDR-SOB at 24 months of treatment

    Clinical dementia rating - sum of boxes

    Time frame: 24 month

Secondary outcomes

  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 outcomes

  1. Change in CDR-SOB at Long-Term Follow-Up

    Time frame: 2-11 years

07

Study locations

13 sites
  • Department of Psychiatry and Psychotherapy, Charité-CBF
    Berlin, Germany
  • Department of Psychiatry and Psychotherapy, University Bonn
    Bonn, 53105, Germany
  • Department of Psychiatry and Psychotherapy, University Erlangen
    Erlangen, 91054, Germany
  • Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University
    Frankfurt am Main, 60528, Germany
  • Center for Geriatrics and Gerontology, University Freiburg
    Freiburg, 79106, Germany
  • Department of Psychiatry and Psychotherapy, Medical University Goettingen
    Göttingen, 37075, Germany
  • Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg
    Halle, 06112, Germany
  • Department of Psychiatry, University Hospital Heidelberg
    Heidelberg, 69115, Germany
  • Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg
    Mannheim, 68072, Germany
  • Department of Psychiatry and Psychotherapy, LMU I
    Munich, 80336, Germany
  • Institute for Stroke and Dementia Research, LMU
    Munich, 81377, Germany
  • Department of Psychiatry and Psychotherapy, University Rostock
    Rostock, Germany
  • Neurologische Universitätsklinik Ulm
    Ulm, 89081, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00842920
Lead sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
Responsible party
Isabella Heuser (Prof. Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Feb 12, 2009
Start date
Dec 2008
Primary completion
Aug 31, 2020 (estimated)
Completion
Feb 28, 2021 (estimated)
Last update
Jan 27, 2020

Study contacts

Isabella Heuser, MD, PhD
principal investigator · Charité-CBF
Lutz Frölich, MD
principal investigator · CIMH Mannheim

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cognitive Dysfunction→

Other studies from this sponsor

Charite University, Berlin, Germany

Start the discussion