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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
520
Department of Psychiatry and Psychotherapy, Charité-CBF
Berlin, Germany
Department of Psychiatry and Psychotherapy, University Bonn
Bonn, Germany
Change in CDR-SOB at 24 months of treatment
Clinical dementia rating - sum of boxes
Time frame: 24 month
Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Time frame: 24 month
Change in Free and Cued Selective Reminding Test (FCSRT) score
Time frame: 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
Time frame: 24 months
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Department of Psychiatry and Psychotherapy, University Erlangen
Erlangen, Germany
Department of Psychiatry and Psychotherapy, Johann Wolfgang Goethe-University
Frankfurt am Main, Germany
Center for Geriatrics and Gerontology, University Freiburg
Freiburg im Breisgau, Germany
Department of Psychiatry and Psychotherapy, Medical University Goettingen
Göttingen, Germany
Department for Psychiatry, Psychotherapy and Psychosomatic; Martin-Luther-University Halle-Wittenberg
Halle, Germany
Department of Psychiatry, University Hospital Heidelberg
Heidelberg, Germany
Department of Gerontopsychiatry, Central Institut of Mental Health, University Heidelberg
Mannheim, Germany
Department of Psychiatry and Psychotherapy, LMU I
Munich, Germany
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