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Management of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL (MICOIL)

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ClinicalTrials.gov Identifier: NCT03362996
Recruitment Status : Recruiting
First Posted : December 5, 2017
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
Greek Alzheimer's Association and Related Disorders

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


Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil Combination Product: extra virgin olive oil Other: mediterranean diet Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : November 9, 2016
Estimated Primary Completion Date : February 15, 2018
Estimated Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Olive oil

Arm Intervention/treatment
Experimental: Experimental Group

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)

Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil
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

Placebo Comparator: Control group 1
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)
Combination Product: extra virgin olive oil
Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days

Control Group 2
50 patients that will have the same dietary habits and a Mediterranean dietary protocol
Other: mediterranean diet
50 patients that will have the same dietary habits and a Mediterranean dietary protocol




Primary Outcome Measures :
  1. Neuropsychological Assessment- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Mini-Mental State Examination (MMSE) score

  2. FUCAS-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Functional cognitive assessment scale (FUCAS) score

  3. Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Letter & Category Fluency Test

  4. CDR- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)

  5. MoCA- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Montreal Cognitive Assessment (MoCA)

  6. CANTAB- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)

  7. Clock Drawing test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Clock Drawing test

  8. Logical Memory test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Logical Memory test

  9. Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Digit Span Forward & Backward test

  10. WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the WAIS-R Digit Symbol Substitution Test

  11. TMT part A and B- Measurements to Assess General Cognitive Function [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Trail Making Test

  12. ADASCog-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)

  13. Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality [ Time Frame: baseline, 12 and 24 months ]
    Changes in Functional Rating Scale for Dementia (FRSSD)

  14. Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Auditory Verbal Learning Test

  15. Boston Naming Test- Measurement to Assess Verbal Fluency and Learning [ Time Frame: baseline, 12 and 24 months ]
    Changes in the Boston Naming Test


Secondary Outcome Measures :
  1. NeuroImaging [ Time Frame: baseline and 24 months ]
    Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy) [Time Frame: baseline, 24 month]

  2. CSF - beta amyloid [ Time Frame: baseline and 24 months ]
    Changes in mean values on high sensitivity beta-amyloid 1-42 protein

  3. CSF TAU-protein [ Time Frame: baseline and 24 months ]
    Changes in mean values on TAU-protein in cerebrospinal fluid

  4. Neurophysiology and ERPs [ Time Frame: baseline, 12 and 24 months ]
    •Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) [Time frame: baseline, 12 month, 24 month]

  5. Electroencephalography recording [ Time Frame: baseline, 12 and 24 months ]
    •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]


Other Outcome Measures:
  1. Weight in Kilograms [ Time Frame: baseline, 12 and 24 months ]
    Changes in weight

  2. Height in Meters [ Time Frame: baseline, 12 month and 24 month ]
    Changes in Height



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362996


Contacts
Contact: Magda Tsolaki, Professor 0030 2310 2411 56 tsolakim1@gmail.com
Contact: Eutuchia Lazarou, MSc 0030 6934664446 lazfelicia@gmail.com

Locations
Greece
Greek Association of Alzheimer's Disease and Related Disordeers Recruiting
Thessaloniki, Greece, 54248
Contact: Ersi Grammatikou, Msc    00302310351451 ext 68      
Contact: Moesis Gialaouzidis, BSc    00302310351451 ext 23    moses_gf@hotmail.com   
Sponsors and Collaborators
Greek Alzheimer's Association and Related Disorders
Investigators
Principal Investigator: Magda Tsolaki, Professor Greek Alzheimer's Association and Related Disorders

Publications:
Responsible Party: Greek Alzheimer's Association and Related Disorders
ClinicalTrials.gov Identifier: NCT03362996     History of Changes
Other Study ID Numbers: 25/201614
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Not available at this stage

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Greek Alzheimer's Association and Related Disorders:
extra virgin olive oil
mild cognitive impairment
randomized double blind clinical trial

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders