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

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ClinicalTrials.gov Identifier: NCT03824197
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Amal Kaddoumi, Auburn University

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Cerebral Amyloid Angiopathy Other: EVOO Other: OO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
EVOO-phenol high
Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet
Other: EVOO
Extra-virgin olive oil that is rich with oleocanthal and other phenols.
Other Name: OC-rich EVOO

OO-phenol low
Olive oil with low phenolic content that will be added to daily diet
Other: OO
Olive oil low in oleocanthal and other phenols.
Other Name: Olive oil




Primary Outcome Measures :
  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 Outcome Measures :
  1. Cognitive function [ Time Frame: 6 months ]
    A battery of cognitive tasks to assess memory



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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Amal Kaddoumi, Professor, Auburn University
ClinicalTrials.gov Identifier: NCT03824197     History of Changes
Other Study ID Numbers: 18-446 MR 1901
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Alzheimer Disease
Cerebral Amyloid Angiopathy
Cerebral Amyloid Angiopathy, Familial
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebral Arterial Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Cerebral Small Vessel Diseases
Amyloidosis, Familial
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Phenol
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Sclerosing Solutions