BACKGROUND: Mild cognitive impairment (MCI) constitutes a form of preclinical dementia and characterizes a cognitive decline that exceeds what is expected for one's age and education status, but at the same time does not fulfill the criteria for dementia. MCI is considered a prodromal stage of Alzheimer's disease (AD) and the progression to this neurodegenerative disease, renders the patients heavily dependent on their relatives and the society, which creates a huge psychological and financial burden, since no effective treatment exists for MCI and AD to this day. Mediterranean diet (MeDi) displays beneficial effects on the cognitive function of both healthy individuals and cognitive impaired patients. High Phenolic Early Harvest Extra Virgin Olive Oil (HP-EH-EVOO) is a natural product that contains high concentrations of the substance Oleocanthal (OLC), while at the same time it has been shown to exert beneficial properties on the cognitive function of cognitive impaired individuals, as well as on the slowing down of the decline of cognitive function.
AIM: The main hypothesis that will be evaluated is whether the combined approach of the MeDi pattern and the concurrent intervention with the administration in a capsule form of the supplement containing olive oil polyphenols with the main substance being Oleocanthal (SUPOL), could constitute a considerable strategy of management of MCI patients.
Study Type: Investigational Study Design, Allocantion: Randomized Intervention Model, Parallel Assignment Masking: Double Blind (Subject, Outcome Assessor - Investigator) on Supplement, Primary Purpose: Prevention.
Men or women,
60 to 85 years of age inclusive, at the time of signing the informed consent form (ICF).
Mini-Mental State Examination (MMSE) score of 26-28 at Screening (Visit 1).
Montreal Cognitive Assessment (MoCA) score of 20-26 at Visit 1.
Significant neurological diseases that affect the central nervous system other than MCI, that may affect cognition ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease (PD), Multiple sclerosis (MS), multiple concussions, epilepsy or recurrent seizures.
Ongoing serious or unstable illnesses, including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, psychiatric, immunologic, hema-tologic diseases and other conditions that, in the PI's opinion, could interfere with the analyses in this study or has a life expectancy of less than 24 months.
History of cancer within the last 5 years, with exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, other cancers with low risk of recurrence or spread.
Participants with any current primary psychiatric diagnosis, if in the judgement of the PI for the psychiatric disorder or symptom is likely to confound interpretation of the combined approach effect, affect cognitive assessment or affect the partici-pant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
Parallel
SUPOL
Dietary supplementSupplement containing Olive Oil Polyphenol with the main substance being Oleocanthal (SUPOL), 2 capsules twice a day (4 capsules total) for 12 months.
Dietary Pattern: MeDi
Other interventionHigh Adherance to MeDi pattern to be followed for 12 months.
ADAS-Cog - Measurement to Assess the Severity of Cognitive Impairment
Alzheimer's Disease Assessment Scale - Cognitive Subscale - 13 (ADAS-Cog-13) neuropsychological assessment scale scores ranges from 0 to 85, with greater scores showing a more significant cognitive impairment
MMSE - Measurement to Assess and Evaluate Cogntive Function
Mini-Mental State Examination (MMSE) score ranges range from 0 to 30 and individuals will lower MMSE scores show greater cognitive impairment
MoCA - Measurement to Assess Cognitive Abilities
Montreal Cognitive Assessment (MoCA) total score ranges from 0 to 30 and lower scores indicating greater impairment
ADCS-ADL-MCI - Measurement to Assess and Evaluate the Performance in Different Activities of Daily Living
Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-ADL-MCI) MCI scale score ranges from 0 to 53, with poorer scores representing a more significant cognitive impairment
CDR-SB - Measurement to Assess the Severity of the Disease and the Progression of the Disease
Clinical Dementia Rating Sum of Boxes (CDR-SB) total score ranges from 0 to 18, with greater scores corresponding to more significant impairment
CDR - Measurement of Time to Progression to Dementia
Clinical Dementia Rating (CDR) global score ranges from 0 to 3, with the higher score corrisponding to severe dementia and the time to progression to dementia will be measured in weeks (unit)
Measurment of Change in Plasma Aβ1-42
Change in mean values of beta-amyloid 1-42 protein (Aβ1-42) plasma concentration
Measurment of Change in Plasma Aβ1-40
Change in mean values of beta-amyloid 1-40 protein (Aβ1-40) plasma concentration
Measurement of Change in the Aβ1-42/Aβ1-40 Plasma Ratio
Change in the Amyloid-β1-42/Amyloid-β1-40 (Aβ1-42/Aβ1-40) ration in plasma levels
Measurment of Change in Plasma pTau-181
Change in mean values of phosphorylated Tau-181 protein (pTau-181) plasma concentration
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Aristotle University Of Thessaloniki
Lead sponsor
Greek Alzheimer's Association and Related Disorders
Collaborator
University of Glasgow
Collaborator
World Olive Center for Health
Collaborator
National and Kapodistrian University of Athens
Collaborator
