Mild Cognitive Impairment Clinical Trial
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
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.
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