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

This study is currently recruiting participants.
Verified February 2013 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Isabella Heuser, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00842920
First received: February 11, 2009
Last updated: February 6, 2013
Last verified: February 2013
History of Changes

February 11, 2009
February 6, 2013
December 2008
January 2014   (final data collection date for primary outcome measure)
Length of conversion-free interval, starting at the time of randomization, with conversion being defined as an increase of the Clinical Dementia Rating (CDR) score beyond 0.5 [ Time Frame: 24 month ] [ Designated as safety issue: No ]
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 month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00842920 on ClinicalTrials.gov Archive Site
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Free and Cued Selective Reminding Test (FCSRT) score [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Change in ADAS-Cog and FCSRT score [ Time Frame: 24 month ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial of Simvastatin in Amnestic Mild Cognitive Impairment (MCI) Patients
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 Simvastatin significantly reduces the risk of conversion to Alzheimer's disease in individuals with MCI as compared to MCI receiving placebo.

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. Subjects will be randomly assigned to one of 2 treatment arms: (1) Simvastatin (60 mg) one tablet/day (2) Placebo one tablet/day.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Mild Cognitive Impairment
  • Drug: Simvastatin
    60 mg once daily
  • Drug: Placebo
    one tablet once daily
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Simvastatin
    Simvastatin 60 mg once daily
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
640
January 2014
January 2014   (final data collection date for primary outcome measure)

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 85.
  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 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
Both
55 Years to 85 Years
No
Not Provided
Germany
 
NCT00842920
EudraCT 2008-002226-11, BMBF grant, 01KG0822
Yes
Isabella Heuser, Charite University, Berlin, Germany
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Principal Investigator: Isabella Heuser, MD, PhD Charité-CBF
Principal Investigator: Lutz Frölich, MD CIMH Mannheim
Charite University, Berlin, Germany
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP