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临床试验/NCT03824197
NCT03824197已完成不适用

Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease

Auburn University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年5月7日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Effect of olive oil on the BBB intactness
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Until now there is no medical treatment and/or intervention that can slow, stop or reverse the underlying neurodegenerative of Alzheimer's disease (AD). The goal of this study is to demonstrate "Oleocanthal rich-extra-virgin olive oil (EVOO) consumption stops or delay mild cognitive impairment conversion to AD by restoring the blood-brain barrier (BBB) function in humans".

Specific Aims:

  1. Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI).
  2. Evaluate effect of EVOO on cognitive function and on selected biomarkers

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
Double (Participant, Care Provider)

入排标准

年龄范围
55 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Men and women, experiencing mild cognitive impairment with:
  • •Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level
  • •memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI
  • •Clinical Dementia Rating (CDR) score 0.5.

排除标准

  • •Subjects with contradictions for MRI include: the presence of metal or electronic devices such as metallic joint prostheses, artificial heart valves, an implantable heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel or any other type of metal fragment; breathing problems or disorders, claustrophobia, inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains metal, and body piercing jewelry that cannot be removed.
  • •Subjects will be excluded if they are smokers
  • •Subjects who have have clinically important medical or neuropsychiatric comorbidity.
  • •Subjects who have renal problems or are allergic to the MRI contrast agent.

结局指标

主要结局

Effect of olive oil on the BBB intactness

时间窗: 6 months

Will be evaluated by DCE-MRI

Effect of olive oil on the brain activity

时间窗: 6 months

Will be evaluated by fMRI

次要结局

  • Cognitive function(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amal Kaddoumi

Professor

Auburn University

研究点 (2)

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