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

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ClinicalTrials.gov Identifier: NCT02045056
Recruitment Status : Active, not recruiting
First Posted : January 24, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gregory Jicha, 323-5550, University of Kentucky

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Preclinical Alzheimer's Disease Drug: Gemfibrozil Drug: Placebo Early Phase 1

Detailed Description:
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  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Gemfibrozil

Arm Intervention/treatment
Experimental: Gemfibrozil
Gemfibrozil 600 mg by mouth twice daily for 48 weeks
Drug: Gemfibrozil
Placebo Comparator: Sugar pill
Matching placebo capsule by mouth twice daily for 48 weeks
Drug: Placebo



Primary Outcome Measures :
  1. Safety [ Time Frame: 52 weeks ]
    Adverse events reported during the course of the trial

  2. microRNA-107 levels [ Time Frame: 48 weeks ]
    MicroRNA-107 levels will be measured in serum and cerebrospinal fluid

  3. beta-amyloid levels [ Time Frame: 48 weeks ]
    Beta-amyloid 1-40 and 1-42 levels will be measured in cerebrospinal fluid at baseline and at 48 weeks


Secondary Outcome Measures :
  1. Free and cued selective reminding test (FCSRT) [ Time Frame: 48 weeks ]
    The FCSRT is a sensitive measure of memory performance that will be measured at baseline and after 48 weeks of gemfibrozil treatment

  2. Paired associates learning (PAL) [ Time Frame: 48 weeks ]
    The PAL is a sensitive, computerized measure of memory performance that will be measured at baseline and after 48 weeks of gemfibrozil treatment



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Participants must meet all of the following inclusion criteria in order to participate in the study:

  1. Men or women aged 65-90, inclusive.
  2. Stable medical condition for three 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 of other laboratory studies (CBC, chemistry panel)
  3. Non-diabetic or well controlled diabetes confirmed by fasting serum glucose <126 mg/dL.
  4. Stable medications for 4 weeks prior to screening visit.
  5. Physically acceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.

    • Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the Project Director.

Exclusion Criteria:

  1. Female participants that are pregnant or of childbearing potential.
  2. Unstable medical conditions for three months prior to screening visit such as poorly controlled blood pressure, diabetes, or breathing problems…etc.
  3. Clinically significant abnormalities on liver, kidney or other blood tests
  4. Significant neurologic disease such as Alzheimer's disease, Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder.
  5. Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse.
  6. History of invasive cancer within the past two years.
  7. Contra-indications to lumbar puncture (bleeding disorder, platelet count < 100,000, anticoagulant treatment, major structural abnormality or sepsis in the area of the lumbosacral spine that would make a lumbar puncture technically difficult).
  8. Use of any investigational agents within 30 days prior to screening.
  9. Contra-indications to MRI (metallic implants, pacemaker, shrapnel, ect…)
  10. Sensitivity, intolerance, or allergies to gemfibrozil or any previous reaction to any cholesterol lowering medicine.
  11. Major surgery within eight weeks prior to the Baseline Visit.
  12. Blindness, deafness, language difficulties or any other disability which may prevent the potential participant from participating or cooperating in the protocol.
  13. Physically unacceptable for this study as confirmed by medical history, physical exam, neurological exam and clinical tests.

    • Exceptions to these criteria may be considered on a case-by-case basis, at the discretion of the examining study physician.

Excluded Medications:

  1. Experimental drugs
  2. Repaglinide
  3. "Statins" including but not limited to atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor), or any combination medicines containing these drugs.
  4. Coumadin, warfarin, heparin, lovenox, Xarelto, apixaban or other anticoagulants. (Antiplatelet therapy is acceptable).

NOTE: If these drugs are discontinued 4 weeks or more before screening, then the participant can be eligible for the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045056


Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536-0230
Sponsors and Collaborators
Gregory Jicha, 323-5550
Investigators
Principal Investigator: Gregory A Jicha, MD, PhD University of Kentucky

Responsible Party: Gregory Jicha, 323-5550, Sponsor/PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT02045056     History of Changes
Other Study ID Numbers: R01AG042419 ( U.S. NIH Grant/Contract )
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Keywords provided by Gregory Jicha, 323-5550, University of Kentucky:
Alzheimer disease
mild cognitive impairment
normal cognition

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Gemfibrozil
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors