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

NCT00842920 | Unknown Phase 4 DMC

• 2 other identifiers: EudraCT 2008-002226-11BMBF grant, 01KG0822
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 13

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

Conditions

Mild Cognitive Impairment

Keywords

amnestic MCI

Outcome Measures

Primary Outcomes (1)

• Change in CDR-SOB at 24 months of treatment

  Clinical dementia rating - sum of boxes

  24 month

Secondary Outcomes (3)

• Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score

  24 month

• Change in Free and Cued Selective Reminding Test (FCSRT) score

  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

  24 months

Other Outcomes (1)

• Change in CDR-SOB at Long-Term Follow-Up

  2-11 years

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Simvastatin 60 mg

EXPERIMENTAL

Simvastatin 60 mg once daily

Drug: Simvastatin 60 mg

Simvastatin 20 mg

EXPERIMENTAL

Simvastatin 20 mg once daily

Drug: Simvastatin 20 mg

Interventions

Simvastatin 60 mg DRUG

60 mg once daily

Simvastatin 60 mg

Placebo DRUG

one tablet once daily

Placebo

Simvastatin 20 mg DRUG

20 mg once daily

Simvastatin 20 mg

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (13)

Department of Psychiatry and Psychotherapy, Charité-CBF

Berlin, Germany

Location

Department of Psychiatry and Psychotherapy, University Bonn

Bonn, 53105, Germany

Location

Department of Psychiatry and Psychotherapy, University Erlangen

Erlangen, 91054, Germany

Location

Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University

Frankfurt am Main, 60528, Germany

Location

Center for Geriatrics and Gerontology, University Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Department of Psychiatry and Psychotherapy, Medical University Goettingen

Göttingen, 37075, Germany

Location

Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg

Halle, 06112, Germany

Location

Department of Psychiatry, University Hospital Heidelberg

Heidelberg, 69115, Germany

Location

Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg

Mannheim, 68072, Germany

Location

Department of Psychiatry and Psychotherapy, LMU I

Munich, 80336, Germany

Location

Institute for Stroke and Dementia Research, LMU

Munich, 81377, Germany

Location

Department of Psychiatry and Psychotherapy, University Rostock

Rostock, Germany

Location

Neurologische Universitätsklinik Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Isabella Heuser, MD, PhD

  Charité-CBF

  PRINCIPAL INVESTIGATOR

• Lutz Frölich, MD

  CIMH Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: December 1, 2008
• Primary Completion: August 31, 2020
• Study Completion: February 28, 2021
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

DE (13)