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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 : Completed
First Posted : January 24, 2014
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Gregory Jicha, 323-5550, University of Kentucky

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE January 24, 2014
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
  • Safety [ Time Frame: 52 weeks ]
    Adverse events reported during the course of the trial
  • microRNA-107 levels [ Time Frame: 48 weeks ]
    MicroRNA-107 levels will be measured in serum and cerebrospinal fluid
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
Official Title  ICMJE Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
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
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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Preclinical Alzheimer's Disease
Intervention  ICMJE
  • Drug: Gemfibrozil
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Gemfibrozil
    Gemfibrozil 600 mg by mouth twice daily for 48 weeks
    Intervention: Drug: Gemfibrozil
  • Placebo Comparator: Sugar pill
    Matching placebo capsule by mouth twice daily for 48 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2014)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02045056
Other Study ID Numbers  ICMJE R01AG042419( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gregory Jicha, 323-5550, University of Kentucky
Study Sponsor  ICMJE Gregory Jicha, 323-5550
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory A Jicha, MD, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP