Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02045056 |
Recruitment Status :
Completed
First Posted : January 24, 2014
Last Update Posted : October 8, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preclinical Alzheimer's Disease | Drug: Gemfibrozil Drug: Placebo | Early Phase 1 |
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 |
Actual Study Completion Date : | June 2019 |

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 |
- 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
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years to 90 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Participants must meet all of the following inclusion criteria in order to participate in the study:
- Men or women aged 65-90, inclusive.
- 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)
- Non-diabetic or well controlled diabetes confirmed by fasting serum glucose <126 mg/dL.
- Stable medications for 4 weeks prior to screening visit.
-
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:
- Female participants that are pregnant or of childbearing potential.
- Unstable medical conditions for three months prior to screening visit such as poorly controlled blood pressure, diabetes, or breathing problems…etc.
- Clinically significant abnormalities on liver, kidney or other blood tests
- Significant neurologic disease such as Alzheimer's disease, Parkinson's disease, stroke, brain tumor, multiple sclerosis or seizure disorder.
- 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.
- History of invasive cancer within the past two years.
- 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).
- Use of any investigational agents within 30 days prior to screening.
- Contra-indications to MRI (metallic implants, pacemaker, shrapnel, ect…)
- Sensitivity, intolerance, or allergies to gemfibrozil or any previous reaction to any cholesterol lowering medicine.
- Major surgery within eight weeks prior to the Baseline Visit.
- Blindness, deafness, language difficulties or any other disability which may prevent the potential participant from participating or cooperating in the protocol.
-
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:
- Experimental drugs
- Repaglinide
- "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.
- 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.

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
United States, Kentucky | |
University of Kentucky | |
Lexington, Kentucky, United States, 40536-0230 |
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 |
Other Study ID Numbers: |
R01AG042419 ( U.S. NIH Grant/Contract ) |
First Posted: | January 24, 2014 Key Record Dates |
Last Update Posted: | October 8, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Alzheimer disease mild cognitive impairment normal cognition |
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 |