NCT02045056已完成早期 1 期
Modulation of Micro-RNA Pathways by Gemfibrozil in Predementia Alzheimer Disease
Gregory Jicha, 323-55501 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- beta-amyloid levels
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Gemfibrozil
Experimental
Gemfibrozil 600 mg by mouth twice daily for 48 weeks
干预措施: Gemfibrozil (Drug)
Sugar pill
Placebo Comparator
Matching placebo capsule by mouth twice daily for 48 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
beta-amyloid levels
时间窗: 48 weeks
Beta-amyloid 1-40 and 1-42 levels will be measured in cerebrospinal fluid at baseline and at 48 weeks
Safety
时间窗: 52 weeks
Adverse events reported during the course of the trial
microRNA-107 levels
时间窗: 48 weeks
MicroRNA-107 levels will be measured in serum and cerebrospinal fluid
次要结局
- Free and cued selective reminding test (FCSRT)(48 weeks)
- Paired associates learning (PAL)(48 weeks)
研究者
Gregory Jicha, 323-5550
Sponsor/PI
University of Kentucky
研究点 (1)
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