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| Name | Class |
|---|---|
| Med & Food and Schena Foundation | UNKNOWN |
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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:
Each subject will perform:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with assumption of EVOO-C | Experimental | 12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg EVOO-C |
|
| Patients with assumption of ROO | Experimental | 12 patients with Mild Cognitive Impairment or Mild Alzheimer's Disease will receive 10 mg ROO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVOO-C | Dietary Supplement | Each patient will consume 10 mg total daily amount EVOO-C |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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)) | 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)) | 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) | Change from baseline optic nerve and macula thickness at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22837695 | Background | Zhao LN, Long HW, Mu Y, Chew LY. The toxicity of amyloid beta oligomers. Int J Mol Sci. 2012;13(6):7303-7327. doi: 10.3390/ijms13067303. Epub 2012 Jun 13. | |
| 26252902 | Background | Coppola G, Di Renzo A, Ziccardi L, Martelli F, Fadda A, Manni G, Barboni P, Pierelli F, Sadun AA, Parisi V. Optical Coherence Tomography in Alzheimer's Disease: A Meta-Analysis. PLoS One. 2015 Aug 7;10(8):e0134750. doi: 10.1371/journal.pone.0134750. eCollection 2015. |
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| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ROO | Dietary Supplement | Each patient will consume 10 mg total daily amount ROO |
|
| 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) | 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. | Change from baseline BAPL at 12 months |
| 3496763 | Background | Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351. |
| 24360540 | Background | Jack CR Jr, Holtzman DM. Biomarker modeling of Alzheimer's disease. Neuron. 2013 Dec 18;80(6):1347-58. doi: 10.1016/j.neuron.2013.12.003. |
| 29387532 | Background | Caminiti SP, Ballarini T, Sala A, Cerami C, Presotto L, Santangelo R, Fallanca F, Vanoli EG, Gianolli L, Iannaccone S, Magnani G, Perani D; BIOMARKAPD Project. FDG-PET and CSF biomarker accuracy in prediction of conversion to different dementias in a large multicentre MCI cohort. Neuroimage Clin. 2018 Jan 28;18:167-177. doi: 10.1016/j.nicl.2018.01.019. eCollection 2018. |
| D003704 |
| Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D024801 | Tauopathies |