Trial | NCT00842920  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    simvastatin ...

  • Study Participants

    520
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
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 Started
Dec 31
2008
Primary Completion
Aug 31
2020
Anticipated
Study Completion
Feb 28
2021
Anticipated
Last Update
Jan 27
2020

Drug Simvastatin 60 mg

60 mg once daily

Drug Placebo

one tablet once daily

Drug Simvastatin 20 mg

20 mg once daily

Placebo Placebo Comparator

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

Simvastatin 60 mg Experimental

Simvastatin 60 mg once daily

Simvastatin 20 mg Experimental

Simvastatin 20 mg once daily

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
No Results Posted