Alzheimer Disease(AU-ROOAD)NCT03824197
Auburn University Research on Olive Oil for Alzheimer's Disease (AU-ROOAD)
A study testing EVOO and OO in people with Alzheimer Disease and Cerebral Amyloid Angiopathy, run by Auburn University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Alzheimer Disease, Cerebral Amyloid Angiopathy
- What is being tested?
- EVOO and OO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
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
- Conditions
- Alzheimer Disease, Cerebral Amyloid Angiopathy
- Being tested
- EVOO, OO
- Medical subject headings
- Alzheimer Disease, Cerebral Amyloid Angiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVOOOther
Also called OC-rich EVOO
Extra-virgin olive oil that is rich with oleocanthal and other phenols.
OOOther
Also called Olive oil
Olive oil low in oleocanthal and other phenols.
| Study group | Role | What they receive |
|---|---|---|
| EVOO-phenol high | Other | Extra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet Receives: Other: EVOO |
| OO-phenol low | Other | Olive oil with low phenolic content that will be added to daily diet Receives: Other: OO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of olive oil on the BBB intactness
Will be evaluated by DCE-MRI
Measured: 6 months
Effect of olive oil on the brain activity
Will be evaluated by fMRI
Measured: 6 months
Secondary outcomes (1)
Cognitive function
A battery of cognitive tasks to assess memory
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start7 May 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Kaddoumi, Auburn University
- Investigators
- Amal Kaddoumi, PhD, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824197
- Sponsor's protocol ID
- 18-446 MR 1901
- Acronym
- (AU-ROOAD)
- Status last verified
- Jul 2021
- First submitted
- 28 Jan 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extra-virgin Olive Oil Prevents Mild Cognitive Impairment Conversion to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03824197
- Acronym / sponsor ID
- (AU-ROOAD) / 18-446 MR 1901
- Conditions
- Alzheimer Disease, Cerebral Amyloid Angiopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVOO-phenol high | Other | Other: EVOOExtra-virgin olive oil rich with oleocanthal and other phenolic compounds that will be added to daily diet |
| OO-phenol low | Other | Other: OOOlive oil with low phenolic content that will be added to daily diet |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVOOAlso: OC-rich EVOOExtra-virgin olive oil that is rich with oleocanthal and other phenols. | Other | EVOO-phenol high |
| OOAlso: Olive oilOlive oil low in oleocanthal and other phenols. | Other | OO-phenol low |
Primary outcome
Effect of olive oil on the BBB intactness
Time frame: 6 months
Will be evaluated by DCE-MRI
Effect of olive oil on the brain activity
Time frame: 6 months
Will be evaluated by fMRI
1 secondary outcome
Cognitive function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Kaddoumi, PhD principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVOO and OO in people with Alzheimer Disease and Cerebral Amyloid Angiopathy, run by Auburn University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of olive oil on the BBB intactness (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.