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Completed

NCT Number: NCT03824197

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

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

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Key information

Conditions

Alzheimer Disease Amyloidosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Amyloid Angiopathy Cerebral Arterial Diseases Cerebrovascular Disorders Dementia Intracranial Arterial Diseases Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Tauopathies Vascular Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auburn University

Auburn, Alabama, 36849, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EVOO

Other

Extra-virgin olive oil that is rich with oleocanthal and other phenols.

Other names: OC-rich EVOO

OO

Other

Olive oil low in oleocanthal and other phenols.

Other names: Olive oil

Primary outcomes

  1. Effect of olive oil on the BBB intactness

    Time frame: 6 months

    Will be evaluated by DCE-MRI

  2. Effect of olive oil on the brain activity

    Time frame: 6 months

    Will be evaluated by fMRI

Secondary outcomes

  1. Cognitive function

    Time frame: 6 months

    A battery of cognitive tasks to assess memory

Sponsors and collaborators

Lead sponsor

Auburn University

Other

Registry information

Official study title

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

Acronym: (AU-ROOAD)

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2019
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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