Alzheimer's Disease is a neurodegenerative disease age related caused by neurofibrillary tangles misfolding and Beta-amyloid protein accumulation. In the last decade several findings showed the role of biophenols present in diary intake such as extra virgin olive oil as potential antagonist of neurodegeneration. Two population studies (The Seven Countries Study and Three-City-Study) and four clinical trials (PREDIMED, PREDIMED - NAVARRA, ACTRIN and ISRCTN) have already suggested that mediterranean diet or other diets supplemented with extra virgin olive oil could improve cerebral performance.
24 MCI or Alzheimer's Disease patients will be recruited and randomised; 12 of them will receive extra virgin olive oil "coratina" (EVOO-C); 12 of them will receive biophenol low dose olive oil (ROO). Each patient will consume a total amount of 10 mg olive oil in a year (12 months). Clinical assessement will be based on: * neurological examination (T0, T6, T12); * cardiological examination (T0, T12): a supra-aortic vessels and brachial artery ecocolordoppler will be performed; * ophthalmological evaluation (T0, T12): a optic coherence tomography will be performed; * neuropsychological assessment (T0, T12); * nutritional assessement(T0, T3, T6, T9, T12). Each subject will perform: * brain MRI (T0, T12); * Beta Amyloid Positron Emission Tomography (T0, T12) A lumbar puncture will be ruled as well (T0) and markers of neurodegeneration (Beta-amyloid 1 - 42, total tau protein, fosfo-tau, Brain Derived Neurotrophic Factor (BDNF), Neurofilament (NFL) will be quantified); Renal, hepatic and nutritional status will be assessed 3 times in 12 months (T0, T6, T12).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
24
Evaluate the change of cerebral performance after olive oil supplementation.
The change of cerebral performance will be documented by neuropsychological assessement with Minimental State Examination (MMSE) (total score)
Time frame: Change from baseline MMSE score at 12 months
Evaluate the change of nutritional parameters after olive oil supplementation
Weight and height will be combined to report BMI in Kg/m\^2. Nutritional assessment will be measured comparing the variation of BMI of each patient during the follow up.
Time frame: Change from baseline BMI at 3 months, from baseline BMI at 6 months, from baseline BMI at 12 months
Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analisys (cerebrospinal level of Beta-amiloid, Tau and phospotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))
Time frame: Change from baseline neurodegenerative biomarkers at 3 months, from baseline neurodegenerative biomarkerse at 6 months, from baseline neurodegenerative biomarkers at 12 months
Evaluate the change of neurodegenerative biomarkers after olive oil supplementation.
Neurodegenerative biomarkers will be tested with blood samples and with cerebrospinal fluid analysis (cerebrospinal level of Beta-amyloid, Tau and phosphotau, BDNF (pg/mL; blood level of BDNF e NFL (pg/mL))
Time frame: Change from baseline neurodegenerative biomarkers at 12 months
Evaluate the change of optic nerve and macula thickness after olive oil supplementation.
Ocular computerized tomography will be performed and layer of retinal nerve fiber will be measured (micron)
Time frame: Change from baseline optic nerve and macula thickness at 12 months
Evaluate the change of cortical thickness with brain MRI after olive oil supplementation.
Brain MRI will be performed to assess cortical thickness using Normalized Thickness Index (NTI)
Time frame: Change from baseline at 12 months
Evaluate the change of brain amyloid plaque load (BAPL) after olive oil supplementation.
Beta amyloid positron emission tomography will be performed measuring a index called BAPL.
Time frame: Change from baseline BAPL at 12 months
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