Alzheimer Disease Clinical Trial
— (AU-ROOAD)Official title:
Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
Verified date | July 2021 |
Source | Auburn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 25 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 75 Years |
Eligibility | Inclusion Criteria: Men and women, experiencing mild cognitive impairment with: 1. Mini-Mental State Exam (MMSE) scores between 18-30 (based on education level 2. memory complaint, have objective memory loss measured by education adjusted scores on Wechsler Memory Scale Logical Memory VI 3. Clinical Dementia Rating (CDR) score 0.5. Exclusion Criteria: 1. 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. 2. Subjects will be excluded if they are smokers 3. Subjects who have have clinically important medical or neuropsychiatric comorbidity. 4. Subjects who have renal problems or are allergic to the MRI contrast agent. |
Country | Name | City | State |
---|---|---|---|
United States | Auburn University | Auburn | Alabama |
Lead Sponsor | Collaborator |
---|---|
Auburn University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of olive oil on the BBB intactness | Will be evaluated by DCE-MRI | 6 months | |
Primary | Effect of olive oil on the brain activity | Will be evaluated by fMRI | 6 months | |
Secondary | Cognitive function | A battery of cognitive tasks to assess memory | 6 months |
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