Back to resultsManagement of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL (MICOIL)
Primary Purpose
Mild Cognitive Impairment
Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Freshly-Pressed Extra Virgin Olive Oil
extra virgin olive oil
mediterranean diet
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring extra virgin olive oil, mild cognitive impairment, randomized double blind clinical trial
Eligibility Criteria
Inclusion Criteria:
- Memory Complaints
- Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R.
- MMSE 24-30
- CDR(sum of boxes) >= 0,5
- Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)
- Geriatric Depression Scale (GDS) <6
- Hachinski Modified Ischemic scale <= 4
- Stability of Permitted Medications for 4 weeks
- Years of education: >= 5
- Proficient language fluency
- Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
- Compliance
Exclusion Criteria:
- Visual and auditory acuity inadequate for neuropsychological testing
- Enrollment in other trials or studies not compatible with MICOIL
- History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
- Use of forbidden medications (listed below)
- Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
Medications across the study
Excluded Medication:
- Antidepressants with anti-cholinergic properties.
- Regular use of narcotic analgesics (>2 doses per week) within 4 weeks of screening.
- Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine) within 4 weeks of screening.
- Chronic use of other medications with significant central nervous system anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).
- Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegeline) within 4 weeks of screening.
- Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).
Sites / Locations
- Greek Association of Alzheimer's Disease and Related DisordeersRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Experimental Group
Control group 1
Control Group 2
Arm Description
50 patients Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days. Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)
50 patients Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days. Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)
50 patients that will have the same dietary habits and a Mediterranean dietary protocol
Outcomes
Primary Outcome Measures
Neuropsychological Assessment- Measurements to Assess General Cognitive Function
Changes in Mini-Mental State Examination (MMSE) score
FUCAS-Measurements to Assess Daily Functionality
Changes in Functional cognitive assessment scale (FUCAS) score
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Letter & Category Fluency Test
CDR- Measurements to Assess General Cognitive Function
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
MoCA- Measurements to Assess General Cognitive Function
Changes in Montreal Cognitive Assessment (MoCA)
CANTAB- Measurements to Assess General Cognitive Function
Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Clock Drawing test- Measurements to Assess General Cognitive Function
Changes in the Clock Drawing test
Logical Memory test- Measurements to Assess General Cognitive Function
Changes in the Logical Memory test
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Changes in the Digit Span Forward & Backward test
WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
Changes in the WAIS-R Digit Symbol Substitution Test
TMT part A and B- Measurements to Assess General Cognitive Function
Changes in the Trail Making Test
ADASCog-Measurements to Assess Daily Functionality
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Changes in Functional Rating Scale for Dementia (FRSSD)
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Auditory Verbal Learning Test
Boston Naming Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Boston Naming Test
Secondary Outcome Measures
NeuroImaging
Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy) [Time Frame: baseline, 24 month]
CSF - beta amyloid
Changes in mean values on high sensitivity beta-amyloid 1-42 protein
CSF TAU-protein
Changes in mean values on TAU-protein in cerebrospinal fluid
Neurophysiology and ERPs
•Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) [Time frame: baseline, 12 month, 24 month]
Electroencephalography recording
•Changes in Electroencephalography (EEG), resting state.The device records brain signals through 57 electrodes, 2 reference electrodes attached to the earlobes, and a ground electrode placed at a left anterior position. [Time frame: baseline, 12 month, 24 month]
Full Information
NCT ID
NCT03362996
First Posted
November 3, 2017
Last Updated
January 5, 2018
Sponsor
Greek Alzheimer's Association and Related Disorders
1. Study Identification
Unique Protocol Identification Number
NCT03362996
Brief Title
Management of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL
Acronym
MICOIL
Official Title
Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of Freshly-Pressed Extra Virgin Olive Oil in the Disease's Progression in Patients Diagnosed With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
February 15, 2018 (Anticipated)
Study Completion Date
May 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Greek Alzheimer's Association and Related Disorders
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is accumulating evidence suggesting that olive oil may have a positive impact on conditions involving cognitive deficits, such as MCI and AD. More specifically, these beneficial effects are mostly attributed to some phenolic compounds in olive oil, such as oleocanthal, oleuropein and ligstroside. Oleocanthal is deeper studied than the rest of olive oil phenol components and it shows promising results in neuroprotection against AD through various suggested mechanisms, such as the enhancement of amyloid-beta clearance in the brain and the inhibition of neurofibrillary tangles formation. For this reason, it would be interesting to study the effects of freshly-pressed extra virgin olive oil, as it is known that it contains oleocanthal in higher concentrations than the normal extra virgin olive oil. The aim of the study is to evaluate the beneficial effect of extra virgin olive oil in comparison to freshly-pressed extra virgin olive oil on patients diagnosed with mild cognitive impairment (MCI).
Study Type: Interventional Study Design: Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Detailed Description
OBJECTIVES OF THE TRIAL
The objectives of this study are:
To investigate the efficacy of freshly pressed EVOO as a disease course modifying treatment for mild cognitive impairment in a phase III double-blind placebo-controlled study.
To investigate the effects in objective measurements in patients with mild cognitive impairment.
STUDY DESIGN This is a Greek, randomized, double-blind, placebo-controlled study group of EVOO compared with placebo. Qualifying patients will be randomly assigned to receive 50mL of freshly-pressed EVOO or placebo (EVOO) or mediterranean dietary protocol on a daily basis for 24 months. Patients undergo assessments at baseline,12 and 24 months +/- 7 days after beginning treatment.
Duration The total study duration will be 30 months. Patients will receive study medication for 24 months.
Number of Subjects 150 subjects total will be enrolled. ; 50 in the experimental group (freshly pressed EVOO); 50 in the Control Group 1(EVOO) and 50 in control Group 2(same dietary habits-mediterranean dietary protocol).
Patient Eligibility Screening Form (ESF)
An eligibility form documenting the patient's fulfillment of the entry criteria will be completed by the assessor. The following information will be included in the ESF:
Patient identification: Initials (First initial of first name and First initial of surname), date of birth and Patient Identification Number.
Eligibility Screening; Checklist of inclusion and exclusion criteria
Eligibility Statement; for patients found to be ineligible, the reason for ineligibility must be stated
Written informed consent will be obtained from the subject . The informed consent form must be co-signed by the physician. The nature of the study and the potential risks associated with the trial will be explained to all subject candidates and their responsible informants.
Signature and date: the ESF may be completed by an assessor but it is required that the principal investigator/study clinician sign and date the ESF to verify eligibility of the patient for inclusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
extra virgin olive oil, mild cognitive impairment, randomized double blind clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
50 patients Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days.
Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)
Arm Title
Control group 1
Arm Type
Placebo Comparator
Arm Description
50 patients Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days. Extra Virgin Olive Oil dietary intake of the content of 50 mL (3 tablespoons from the bottle containing the product)
Arm Title
Control Group 2
Arm Type
Other
Arm Description
50 patients that will have the same dietary habits and a Mediterranean dietary protocol
Intervention Type
Dietary Supplement
Intervention Name(s)
Freshly-Pressed Extra Virgin Olive Oil
Intervention Description
Dietary Supplement: Freshly-pressed extra virgin olive oil Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days
Intervention Type
Combination Product
Intervention Name(s)
extra virgin olive oil
Intervention Description
Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days
Intervention Type
Other
Intervention Name(s)
mediterranean diet
Intervention Description
50 patients that will have the same dietary habits and a Mediterranean dietary protocol
Primary Outcome Measure Information:
Title
Neuropsychological Assessment- Measurements to Assess General Cognitive Function
Description
Changes in Mini-Mental State Examination (MMSE) score
Time Frame
baseline, 12 and 24 months
Title
FUCAS-Measurements to Assess Daily Functionality
Description
Changes in Functional cognitive assessment scale (FUCAS) score
Time Frame
baseline, 12 and 24 months
Title
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Description
Changes in the Letter & Category Fluency Test
Time Frame
baseline, 12 and 24 months
Title
CDR- Measurements to Assess General Cognitive Function
Description
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
Time Frame
baseline, 12 and 24 months
Title
MoCA- Measurements to Assess General Cognitive Function
Description
Changes in Montreal Cognitive Assessment (MoCA)
Time Frame
baseline, 12 and 24 months
Title
CANTAB- Measurements to Assess General Cognitive Function
Description
Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame
baseline, 12 and 24 months
Title
Clock Drawing test- Measurements to Assess General Cognitive Function
Description
Changes in the Clock Drawing test
Time Frame
baseline, 12 and 24 months
Title
Logical Memory test- Measurements to Assess General Cognitive Function
Description
Changes in the Logical Memory test
Time Frame
baseline, 12 and 24 months
Title
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Description
Changes in the Digit Span Forward & Backward test
Time Frame
baseline, 12 and 24 months
Title
WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
Description
Changes in the WAIS-R Digit Symbol Substitution Test
Time Frame
baseline, 12 and 24 months
Title
TMT part A and B- Measurements to Assess General Cognitive Function
Description
Changes in the Trail Making Test
Time Frame
baseline, 12 and 24 months
Title
ADASCog-Measurements to Assess Daily Functionality
Description
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Time Frame
baseline, 12 and 24 months
Title
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Description
Changes in Functional Rating Scale for Dementia (FRSSD)
Time Frame
baseline, 12 and 24 months
Title
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Description
Changes in the Auditory Verbal Learning Test
Time Frame
baseline, 12 and 24 months
Title
Boston Naming Test- Measurement to Assess Verbal Fluency and Learning
Description
Changes in the Boston Naming Test
Time Frame
baseline, 12 and 24 months
Secondary Outcome Measure Information:
Title
NeuroImaging
Description
Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy) [Time Frame: baseline, 24 month]
Time Frame
baseline and 24 months
Title
CSF - beta amyloid
Description
Changes in mean values on high sensitivity beta-amyloid 1-42 protein
Time Frame
baseline and 24 months
Title
CSF TAU-protein
Description
Changes in mean values on TAU-protein in cerebrospinal fluid
Time Frame
baseline and 24 months
Title
Neurophysiology and ERPs
Description
•Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) [Time frame: baseline, 12 month, 24 month]
Time Frame
baseline, 12 and 24 months
Title
Electroencephalography recording
Description
•Changes in Electroencephalography (EEG), resting state.The device records brain signals through 57 electrodes, 2 reference electrodes attached to the earlobes, and a ground electrode placed at a left anterior position. [Time frame: baseline, 12 month, 24 month]
Time Frame
baseline, 12 and 24 months
Other Pre-specified Outcome Measures:
Title
Weight in Kilograms
Description
Changes in weight
Time Frame
baseline, 12 and 24 months
Title
Height in Meters
Description
Changes in Height
Time Frame
baseline, 12 month and 24 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Memory Complaints
Abnormal memory function documented by scoring 1 SD below the age-adjusted mean on the Logical Memory II subscale, (Delayed Paragraph Recall) from the Wechsler Memory Scale-R.
MMSE 24-30
CDR(sum of boxes) >= 0,5
Diagnosis: Mild Cognitive Impairment (amnestic plus multi-domain)
Geriatric Depression Scale (GDS) <6
Hachinski Modified Ischemic scale <= 4
Stability of Permitted Medications for 4 weeks
Years of education: >= 5
Proficient language fluency
Have a study partner with 10+ hr/wk contact (can be in person and telephone), accompanies to visits
Compliance
Exclusion Criteria:
Visual and auditory acuity inadequate for neuropsychological testing
Enrollment in other trials or studies not compatible with MICOIL
History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrollment.
Use of forbidden medications (listed below)
Ferromagnetic implants and devices (including implants or devices held in place by sutures, granulation or ingrowth of tissue, fixation devices, or by other means) not eligible for MRI scanning. Brain malformation or other conditions that may complicate lumbar puncture
Medications across the study
Excluded Medication:
Antidepressants with anti-cholinergic properties.
Regular use of narcotic analgesics (>2 doses per week) within 4 weeks of screening.
Use of neuroleptics with anti-cholinergic properties (e.g., chlorpromazine, thioridazine) within 4 weeks of screening.
Chronic use of other medications with significant central nervous system anticholinergic activity within 4 weeks of screening (e.g., diphenhydramine).
Use of Anti-Parkinsonian medications (including Sinemet, amantadine, bromocriptine, pergolide, selegeline) within 4 weeks of screening.
Participation in any other investigational drug study within 4 weeks of screening (individuals may not participate in any drug study while participating in this protocol).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magda Tsolaki, Professor
Phone
0030 2310 2411 56
Email
tsolakim1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Eutuchia Lazarou, MSc
Phone
0030 6934664446
Email
lazfelicia@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magda Tsolaki, Professor
Organizational Affiliation
Greek Alzheimer's Association and Related Disorders
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greek Association of Alzheimer's Disease and Related Disordeers
City
Thessaloniki
ZIP/Postal Code
54248
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ersi Grammatikou, Msc
Phone
00302310351451
Ext
68
First Name & Middle Initial & Last Name & Degree
Moesis Gialaouzidis, BSc
Phone
00302310351451
Ext
23
Email
moses_gf@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not available at this stage
Citations:
PubMed Identifier
27472878
Citation
Tsolaki M, Karathanasi E, Lazarou I, Dovas K, Verykouki E, Karacostas A, Georgiadis K, Tsolaki A, Adam K, Kompatsiaris I, Sinakos Z. Efficacy and Safety of Crocus sativus L. in Patients with Mild Cognitive Impairment: One Year Single-Blind Randomized, with Parallel Groups, Clinical Trial. J Alzheimers Dis. 2016 Jul 27;54(1):129-33. doi: 10.3233/JAD-160304.
Results Reference
background
PubMed Identifier
34748951
Citation
Tzekaki EE, Tsolaki M, Geromichalos GD, Pantazaki AlphaA. Extra Virgin Olive Oil consumption from Mild Cognitive Impairment patients attenuates oxidative and nitrative stress reflecting on the reduction of the PARP levels and DNA damage. Exp Gerontol. 2021 Dec;156:111621. doi: 10.1016/j.exger.2021.111621. Epub 2021 Nov 5.
Results Reference
derived
PubMed Identifier
33836262
Citation
Tzekaki EE, Tsolaki M, Pantazaki AlphaA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. The pleiotropic beneficial intervention of olive oil intake on the Alzheimer's disease onset via fibrinolytic system. Exp Gerontol. 2021 Jul 15;150:111344. doi: 10.1016/j.exger.2021.111344. Epub 2021 Apr 6.
Results Reference
derived
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Management of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL
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