Alzheimer Disease, Cerebral Amyloid Angiopathy
Conditions
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: 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
Interventions
OTHEREVOO
Extra-virgin olive oil that is rich with oleocanthal and other phenols.
OTHEROO
Olive oil low in oleocanthal and other phenols.
Sponsors
Auburn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of olive oil on the brain activity | 6 months | Will be evaluated by fMRI |
| Effect of olive oil on the BBB intactness | 6 months | Will be evaluated by DCE-MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 6 months | A battery of cognitive tasks to assess memory |
Countries
United States
Outcome results
None listed