Mild Cognitive Impairment (MCI)ATHENANCT07741773
Assessing Treatment With High-phenolic EVOO Supplements for Neurovascular Activity
A study testing EVOO-phenolics dietary supplement in people with Mild Cognitive Impairment (MCI), run by Augusta University at 1 site in United States.
Trial summary
The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- EVOO-phenolics dietary supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CDR (Clinical Dementia Rating) score of 0.5 OR MoCA (Montreal Cognitive Assessment) score of 18-25.
Who cannot join
- History or presence of vascular disease that may affect cognitive function
- History or presence of stroke within the past 1 year
- Recent transient ischemic attack (TIA) within the past 180 days
- History of severe, clinically significant CNS trauma
- History of intracranial tumor
- History or presence of kidney disease (eGFR <60 mL/min/1.73m2)
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- Presence of a pacemaker
- Presence of metal in the body
- Allergic to the MRI contrast agent "Multihance"
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Georgia prevention institute
Augusta, Georgia, 30912
Jacob Looney, MS, (706)-721-5483, jlooney@augusta.edu
About this study
Official title: Dietary Supplementation With EVOO Phenolics Prevents MCI Progression to Alzheimer's Disease
The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). The main questions it aims to answer are:
- Does dietary supplementation with EVOO phenolics improve cognitive function?
- What would be the effect of the EVOO dietary supplement on other MCI-related biomarkers, including vascular function and biological pathways?
Read more
Researchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics)
Participants will:
- Take EVOO dietary supplements or a placebo daily for 6 months
- Visit the study site during the 6-month study for screening and testing.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- EVOO-phenolics dietary supplement, Placebo
- Keywords
- Olive oil, Cognitive function, Cerebrovascular function, MCI
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVOO-phenolics dietary supplementDietary supplement
EVOO phenolic dietary supplement which is standardized to contain10 mg of EVOO total phenolics
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | a look-alike tablet to the intervention that contains no EVOO-phenolics Receives: Dietary Supplement: Placebo |
| EVOO phenolics | Active comparator | EVOO phenolics Receives: Dietary Supplement: EVOO-phenolics dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular function
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on blood barin barrier function using Dynamic Contrast-Enhanced MRI (DCE-MRI)
Measured: At baseline and end of treatment (6 months)
Cerebrovascular blood flow
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cerebrovascular blood flow using Near Infrared Spectroscopy.
Measured: At baseline and end of treament (6 months)
Cognitive function
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cognitive function, the Clinical Dementia Rating (CDR) and the National Institutes of Health (NIH) Toolbox Cognition Battery will be used. CDR and NIH Toolbox cognitive tests will be combined to report the overall effect of the intervention on changes in cognitive function. A CDR score of 0.5 indicates mild cognitive impairment, and a score of 3 indicates dementia. Those with a CDR score of 0 indicate normal cognitive function. For the NIH Toolbox tests, the Total Cognition Composite score is used, with 70 or lower indicating impaired cognition and 130 and above indicating superior cognitive ability.
Measured: At baseline and end of treament (6 months)
Secondary outcomes (3)
Blood biomarkers
Assess concentrations of Aβ40, Aβ42, tau, and p-tau181 using highly sensitive commercially available ELISA kits. All these biomarkers will be assessed in concentration units of ng/ml, where their decrease could indicate efficacy.
Measured: At baseline and end of treatmnet (6 months)
Proteomics
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on changes in blood proteins linked to pathways associated with Alzheimer's disease.
Measured: At baseline and end of treatmnet (6 months)
Metabolomics
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on changes in blood metabolites and lipids linked to pathways associated with Alzheimer's disease.
Measured: At baseline and end of treatment (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amal Kaddoumi, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741773
- Sponsor's protocol ID
- 2445297-2
- Acronym
- ATHENA
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Supplementation With EVOO Phenolics Prevents MCI Progression to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07741773
- Acronym / sponsor ID
- ATHENA / 2445297-2
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Olive oil, Cognitive function, Cerebrovascular function, MCI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 3 Aug 2026 (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.
The goal of this clinical trial is to determine whether the extra-virgin olive oil (EVOO) phenolic dietary supplement can improve memory function and modulate biomarkers among individuals with mild cognitive impairment (MCI). The main questions it aims to answer are:
- Does dietary supplementation with EVOO phenolics improve cognitive function?
- What would be the effect of the EVOO dietary supplement on other MCI-related biomarkers, including vascular function and biological pathways?
Researchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics)
Participants will:
- Take EVOO dietary supplements or a placebo daily for 6 months
- Visit the study site during the 6-month study for screening and testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboa look-alike tablet to the intervention that contains no EVOO-phenolics |
| EVOO phenolics | Active comparator | Dietary Supplement: EVOO-phenolics dietary supplementEVOO phenolics |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- CDR (Clinical Dementia Rating) score of 0.5 OR MoCA (Montreal Cognitive Assessment) score of 18-25.
Key exclusion criteria (10 listed)
- History or presence of vascular disease that may affect cognitive function
- History or presence of stroke within the past 1 year
- Recent transient ischemic attack (TIA) within the past 180 days
- History of severe, clinically significant CNS trauma
- History of intracranial tumor
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 |
|---|---|---|
| EVOO-phenolics dietary supplementEVOO phenolic dietary supplement which is standardized to contain10 mg of EVOO total phenolics | Dietary supplement | EVOO phenolics |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Cerebrovascular function
Time frame: At baseline and end of treatment (6 months)
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on blood barin barrier function using Dynamic Contrast-Enhanced MRI (DCE-MRI)
Cerebrovascular blood flow
Time frame: At baseline and end of treament (6 months)
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cerebrovascular blood flow using Near Infrared Spectroscopy.
Cognitive function
Time frame: At baseline and end of treament (6 months)
To assess the effect of extra virgin olive oil (EVOO) phenolic dietary supplements on cognitive function, the Clinical Dementia Rating (CDR) and the National Institutes of Health (NIH) Toolbox Cognition Battery will be used. CDR and NIH Toolbox cognitive tests will be combined to report the overall effect of the intervention on changes in cognitive function. A CDR score of 0.5 indicates mild cognitive impairment, and a score of 3 indicates dementia. Those with a CDR score of 0 indicate normal cognitive function. For the NIH Toolbox tests, the Total Cognition Composite score is used, with 70 or lower indicating impaired cognition and 130 and above indicating superior cognitive ability.
3 secondary outcomes
Blood biomarkers
Time frame: At baseline and end of treatmnet (6 months)
Proteomics
Time frame: At baseline and end of treatmnet (6 months)
Metabolomics
Time frame: At baseline and end of treatment (6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Amal Kaddoumi, PhD principal investigator
Augusta 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-phenolics dietary supplement in people with Mild Cognitive Impairment (MCI), run by Augusta 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 1 inclusion and 10 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: opening soon, as of the sponsor's last update on 3 Nov 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amal Kaddoumi, PhD (7067234439, akaddoumi@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular function (time frame: At baseline and end of treatment (6 months)). The study lists 3 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 3 Nov 2026.