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

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Preclinical Alzheimer's Disease

In brief

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

Key facts

Study ID

NCT02045056

Run by

Gregory Jicha, 323-5550

People needed

72

Starts

2014-05-01

Expected to finish

2019-06-01

Last updated by the study team

2019-10-08

Who can join

Age: 65 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Kentucky — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.