Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)

Study Overview
=================
Brief Summary
-----------------
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: Evaluate effect of EVOO on the brain function by functional MRI (fMRI) imaging, and BBB function by dynamic contrast-enhanced MRI (DCE-MRI). Evaluate effect of EVOO on cognitive function and on selected biomarkers

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

Conditions
-----------------
Alzheimer Disease, Cerebral Amyloid Angiopathy

Intervention / Treatment
-----------------
* Other: EVOO
* Other: OO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EVOO-phenol high<br>Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet | Other: EVOO<br>* Extra-virgin olive oil that is rich with oleocanthal and other phenols.<br>* Other names: OC-rich EVOO;|
| Other: OO-phenol low<br>Olive oil with low phenolic content that will be added to daily diet | Other: OO<br>* Olive oil low in oleocanthal and other phenols.<br>* Other names: Olive oil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of olive oil on the BBB intactness | Will be evaluated by DCE-MRI | 6 months | 
| Effect of olive oil on the brain activity | Will be evaluated by fMRI | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | A battery of cognitive tasks to assess memory | 6 months |