An interventional study of EVOO-phenolics dietary supplement and Placebo in Mild Cognitive Impairment (MCI), sponsored by Augusta University. Not yet recruiting at 1 site in United States. Open to participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Augusta University · Not applicable, Interventional, and Prevention
Among 1,418 studies in Cognitive Dysfunction with a site in United States — 328 open to participants now, 432 under way, 13 of them phase 3. Cognitive Dysfunction · United States.
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, this one is the 897th largest by planned enrollment of the 1,143 interventional ones, is one of 94 that started in 2026, is one of 713 with no phase, reaches primary completion later than 348 of the 431 other live ones, and was the 1,393rd registered.
3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.
This study's planned enrollment of 20 is below the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →328 of the 1,418 studies in Cognitive Dysfunction with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.
This study: 50 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →1,418 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 94 started in 2026.
Median enrollment 58 across the 1,143 interventional studies, 150 across the 270 observational. Of the 885 that completed or were terminated, 377 (43%) have results posted.
209 of 1,418 have an industry lead sponsor. The 10 most frequent:
Augusta University is the lead sponsor of 180 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Augusta University has 2 studies filed under Cognitive Dysfunction — fewer than ten, so there is no comparison to draw.
180 of the studies in Cognitive Dysfunction with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03860857Phase 3University of California, IrvineBiomarker Exploration in Aging, Cognition and Neurodegeneration | 2026-12-22 |
| NCT03887455Phase 3Eisai Inc.A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease | 2026-12-31 |
| NCT06191965Phase 3Mclean HospitalMitoQ for Early-phase Schizophrenia-spectrum Disorder and Mitochondrial Dysfunction | 2027-01-31 |
| NCT06950190Phase 3Ellis MedicineEvaluating Cognitive Changes on Patients in Chemotherapy (ECCPC) | 2027-02-20 |
| NCT03560960Boston UniversityMulti-Center Development of a Novel Diagnostic Test for Alzheimer's Disease | 2026-11 |
Among the 1,418 studies in Cognitive Dysfunction with a site in United States, from their registry updates:
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:
Researchers will compare the EVOO dietary supplements with a placebo (a look-alike substance that contains no EVOO phenolics)
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
a look-alike tablet to the intervention that contains no EVOO-phenolics
Dietary Supplement: Placebo
EVOO phenolics
Dietary Supplement: EVOO-phenolics dietary supplement
EVOO phenolic dietary supplement which is standardized to contain10 mg of EVOO total phenolics
Placebo
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)
Time frame: 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.
Time frame: 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.
Time frame: At baseline and end of treament (6 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and end of treatment (6 months)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Aug 2028, 20 months later.
Of 1,442 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 51. This study's planned 20 months is below that.
Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Nov 3, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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