The purpose of this study is to assess the safety and efficacy of gemfibrozil in modulating microRNA-107 levels for the prevention of Alzheimer's disease in subjects with intact cognition and mild cognitive impairment
Double-blind, placebo controlled, parallel-design. 48 cognitively-intact subjects, and 24 subjects with early cognitive decline (CDR 0.5) will be randomly assigned to treatment with gemfibrozil (600 mg orally twice a day) or placebo for 52 weeks. Safety assessments will include routine assessment of adverse events, safety labs, and brain magnetic resonance imaging.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
72
University of Kentucky
Lexington, Kentucky, United States
Safety
Adverse events reported during the course of the trial
Time frame: 52 weeks
microRNA-107 levels
MicroRNA-107 levels will be measured in serum and cerebrospinal fluid
Time frame: 48 weeks
beta-amyloid levels
Beta-amyloid 1-40 and 1-42 levels will be measured in cerebrospinal fluid at baseline and at 48 weeks
Time frame: 48 weeks
Free and cued selective reminding test (FCSRT)
The FCSRT is a sensitive measure of memory performance that will be measured at baseline and after 48 weeks of gemfibrozil treatment
Time frame: 48 weeks
Paired associates learning (PAL)
The PAL is a sensitive, computerized measure of memory performance that will be measured at baseline and after 48 weeks of gemfibrozil treatment
Time frame: 48 weeks
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