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Gemfibrozil in Predementia Alzheimer's Disease

Completed

This study will assess the safety and efficacy of the lipid-lowering drug gemfibrozil (Lopid®) for the prevention of Alzheimer's disease in older adults with normal cognition or mild cognitive impairment (MCI). Gemfibrozil is approved by the U.S. Food and Drug Administration to reduce levels of cholesterol and triglycerides in the blood.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years 90 Years Both Accepts Healthy Volunteers
May 2014
June 2019
72

  • Medically stable for 3 months prior to screening visit, with no clinically significant abnormalities of hepatic, renal, and hematologic function, defined as follows:
    • Platelets >100,000
    • Serum creatinine ≤1.6 mg/dL
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤1.5 upper limit of normal
  • No clinically significant abnormalities indicated by other laboratory studies
  • Stable medications for 4 weeks prior to screening visit

  • Women who are pregnant or of childbearing potential
  • Unstable medical conditions for 3 months prior to screening visit, such as poorly controlled blood pressure, diabetes, or breathing problems
  • Clinically significant abnormalities shown by liver, kidney, or other blood tests
  • Significant neurologic disease such as Alzheimer's, Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder
  • Major depression in the past 12 months (DSM-IV criteria); major mental illness such as schizophrenia; alcohol or substance abuse in the past 12 months
  • History of invasive cancer within the past 2 years
  • Contraindication to lumbar puncture, such as bleeding disorder, platelet count <100,000, anticoagulant treatment, major structural abnormality, or sepsis in the area of the lumbosacral spine
  • Use of any investigational agents within 30 days prior to screening
  • Contraindication to MRI, including metallic implants, pacemaker, or shrapnel in the body
  • Sensitivity, intolerance, or allergy to gemfibrozil or any previous reaction to any cholesterol-lowering medicine
  • Major surgery within 8 weeks prior to the baseline visit
  • Blindness, deafness, language difficulties, or any other disability that prevents participation in the study
  • Exceptions to these criteria may be considered on a case-by-case basis
  • Prohibited medications (but if these drugs are discontinued 4 weeks or more before screening, then the participant can be eligible for the study): experimental drugs; repaglinide (Prandin®); statins, including but not limited to atorvastatin (Lipitor®), fluvastatin (Lescol®), lovastatin, pravastatin (Pravachol®), rosuvastatin (Crestor®), simvastatin (Zocor®), or any combination medicines containing these drugs; anticoagulants including warfarin (Coumadin®), heparin, enoxaparin (Lovenox®), rivaroxaban (Xarelto®), and apixaban (Eliquis®). Antiplatelet therapy is acceptable.

Participants will be randomly assigned to take either the study drug, gemfibrozil (600 mg orally twice a day), or a placebo for 1 year. Gemfibrozil is approved by the U.S. Food and Drug Administration to reduce levels of cholesterol and triglycerides in the blood. Researchers will assess the drug's safety and effects on the microRNA-107 pathway in the brain. Specifically, they want to learn if the drug can affect the pathway in a way that may prevent Alzheimer's disease. MicroRNA-107 is a non-coding ribonucleic acid (RNA) involved in the regulation of gene expression.

 

Name City State Zip Status Primary Contact
University of Kentucky
Lexington Kentucky 40536-0230

University of Kentucky

Name Role Affiliation
Gregory A. Jicha, MD, PhD Principal Investigator University of Kentucky

Name Phone Email
Sarah Tarrant 859-323-1331 sarah.tarrant@uky.edu

NCT02045056

Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease