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| Name | Class |
|---|---|
| Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 542 50, Greece. | UNKNOWN |
| Levius Vita Foods srl | UNKNOWN |
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Nutrition is an important modifiable risk factor of human cognitive health. Increasing data suggests that certain nutrients or food ingredients, such as plant polyphenols, have the potential to benefit cognitive abilities even in later life. In terms of polyphenols, Hydroxytyrosol (HT) has gained health benefit claims as a potential preventative antioxidant supplementation of neurodegenerative and amyloid-associated diseases while its pharmacological mechanisms suggest protection against cognitive decline. The primary objective of this study will be to evaluate the effects of HT-rich olive juice polyphenol supplementation alongside MeDi adherence compared with placebo alongside MeDi adherence in the prevention of cognitive decline among patients with Mild Cognitive Impairment associated with AD and non-AD pathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm - Low Dose | Active Comparator | Low dose: 8 drops (20mg of polyphenols) + Mediterranean Diet instructions |
|
| Experimental Arm - High Dose | Experimental | High dose: 16 drops (40mg of polyphenols) + Mediterranean Diet instructions |
|
| Placebo Comparator Arm | Placebo Comparator | Placebo 8 drops + Mediterranean Diet instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement | Dietary Supplement | This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary: Mean change on the Alzheimer's Disease (AD) Assessment Scale-Cognitive Subscale (ADAS-Cog) total score from baseline to Week 52 compared with placebo | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by ADAS-Cog. ADAS-Cog ranges from 0-85 by summing the number of errors made on each task, so that higher scores indicate worse performance. | From baseline to Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Key secondary: Mean change on the Montreal Cognitive Assessment Test (MoCA) total score from baseline to Week 52 compared with placebo | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the cognitive performance of patients with MCI as measured by MoCA. The total possible score for the test is 30 points by summing the number of correct responses given in each task, so higher scores indicate better performance. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percentage change in plasma phosphorylated tau 217 (p-tau217) pg/mL from baseline to Week 52 compared with placebo. | Exploratory analyses will include blood biomarkers, p-tau217 pg/mL. Mean percentage change in plasma p-tau217 pg/mL from baseline to Week 52 compared with placebo. | From baseline to Week 52 |
| Mean percentage change in plasma levels of beta-amyloid 1-42 (Aβ 1-42) pg/mL from baseline to Week 52 compared with placebo. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magda Tsolaki, Professor Emeritus, MD, PhD | Contact | +30 2310316143 | tsolakim1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Vilma Chalili | School of Medicine, Aristotle University of Thessaloniki | Principal Investigator |
| Magda Tsolaki | First Department of Neurology, Faculty of Health Sciences, School of Medicine, Aristotle University of Thessaloniki |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palliative Care Centre "Panagia Glykofilousa", Greek Association of Alzheimer's Disease and Related Disorders, Plastira 65, Thessaloniki 54250, Greece. | Recruiting | Thessaloniki | Central Macedonia | 54250 | Greece |
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|
| High-Dose Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement | Dietary Supplement | This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding. |
|
| Placebo | Dietary Supplement | This is a prospective, randomised, double-blind, three-arm, placebo-controlled with 1:1:1 randomisation and 52-week follow-up trial. The MEDIPHENO-HTrial study will enrol patients within the Mild Cognitive Impairment spectrum related to AD and non-AD type pathologies. Participants will be randomised to receive either 8 drops of the active HT-high phenolic supplement, or 16 drops of the active HT-high phenolic supplement or 8 drops of the matching placebo. The Mediterranean diet adherence support will be delivered identically to all groups to reduce dietary confounding. |
|
| From baseline to Week 52 |
| - Mean change on Clinical Dementia Rating - Sum of boxes (CDR-SB) from baseline to Week 52 compared with placebo | - The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the CDR-SB, which ranges from 0 to 18, and is calculated by summing the ratings across each of the six domains (memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care), with higher scores indicating greater impairment. | From baseline to Week 52 |
| Mean change on Mini-Mental State Examination (MMSE) from baseline to Week 52 compared with placebo | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on the MMSE, which is a 30-point brief screening measure of cognitive status. Higher scores indicate better performance. | From baseline to Week 52 |
| - Mean change on Geriatric Depression Scale-15 (GDS-15) from baseline to Week 52 compared with placebo. | - The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on GDS-15, which consists of 15 items and is used to screen for depression in adults. GDS-15 assess mental health based on feelings over the past week, with higher scores on the measure denoting more severe levels of depressive symptoms. | From baseline to Week 52 |
| - Mean change on Short Anxiety Screening Test (SAST-10) from baseline to Week 52 compared with placebo | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on SAST-10, which is a brief questionnaire designed to assess anxiety. SAST-10 scores range from 10 to 40, with higher scores on the measure denoting more severe levels of anxiety symptoms. | From baseline to Week 52 |
| - Mean change on Functional Rating Scale of Symptoms of Dementia (FRSSD) from baseline to Week 52 compared with placebo. | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on FRSSD. The scale ranges from 0 (fully independent) to 42 (fully dependent), with lower scores indicating better daily functioning. | From baseline to Week 52 |
| - Mean change on Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale for use in Mild Cognitive Impairment (ADCS-MCI-ADL) from baseline to Week 52 compared with placebo. | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on ADCS-MCI-ADL, which is a brief questionnaire designed to capture functional abilities (with recall "In the past 4 weeks"). The 18-item ADCS-ADL-MCI is scored from 0 to 53 based on the subject's degree of independence in performing specific tasks. Lower scores on the measure denote more substantial impairment. | From baseline to Week 52. |
| - Mean change on Quality of life in Alzheimer's disease (QoL-AD) from baseline to Week 52 compared with placebo. | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on QoL-AD, which is a brief 13-item questionnaire designed to assess quality of life. QoL-AD range from 13 to 52, with higher scores indicating better quality of life. | From baseline to Week 52. |
| - Mean change on - Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 52 compared with placebo. | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on PSQI, which is a questionnaire designed to assess Sleep quality. PSQI range from 0 to 21, with higher scores indicating poor sleep. | From baseline to Week 52. |
| - Mean change in LDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo. | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on LDL-C mg/dL cholesterol. | From baseline to Week 52 |
| - Mean change in HDL-C mg/dL cholesterol from baseline to Week 52 compared with placebo. | The effects of Hydroxytyrosol-Rich Olive Juice Polyphenol Supplement compared with placebo on HDL-C mg/dL cholesterol. | From baseline to Week 52 |
Exploratory analyses will include blood biomarkers, Aβ 1-42 pg/mL. Mean percentage change in plasma levels of Aβ 1-42 pg/mL from baseline to Week 52 compared with placebo. |
| From baseline to Week 52 |
| Mean percentage change in plasma Glial Fibrillary Acidic Protein (GFAP) pg/mL concentration from baseline to Week 52 compared with placebo. | Exploratory analyses will include blood biomarkers, GFAP pg/mL. Mean percentage change in plasma GFAP pg/mL concentration from baseline to Week 52 compared with placebo. | From baseline to Week 52 |
|
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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