Mild Cognitive ImpairmentPhase 2MICOILNCT03362996
Management of Mild Cognitive Impairment Patients With Extra Virgin Olive Oil - MICOIL
A Phase 2 study testing Freshly-Pressed Extra Virgin Olive Oil, extra virgin olive oil and mediterranean diet in people with Mild Cognitive Impairment, run by Greek Alzheimer's Association and Related Disorders at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Freshly-Pressed Extra Virgin Olive Oil, extra virgin olive oil and mediterranean diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 9 Nov 2016to 15 May 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Greek Association of Alzheimer's Disease and Related Disordeers
Thessaloniki, 54248
Ersi Grammatikou, Msc, 00302310351451 ext. 68
Moesis Gialaouzidis, BSc, 00302310351451 ext. 23, moses_gf@hotmail.com
About this study
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
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
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Freshly-Pressed Extra Virgin Olive Oil, extra virgin olive oil, mediterranean diet
- Keywords
- extra virgin olive oil, mild cognitive impairment, randomized double blind clinical trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freshly-Pressed Extra Virgin Olive OilDietary supplement
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
extra virgin olive oilCombination product
Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days
mediterranean dietOther
50 patients that will have the same dietary habits and a Mediterranean dietary protocol
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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) Receives: Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil |
| Control group 1 | Placebo comparator | 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) Receives: Combination Product: extra virgin olive oil |
| Control Group 2 | Other | 50 patients that will have the same dietary habits and a Mediterranean dietary protocol Receives: Other: mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological Assessment- Measurements to Assess General Cognitive Function
Changes in Mini-Mental State Examination (MMSE) score
Measured: baseline, 12 and 24 months
FUCAS-Measurements to Assess Daily Functionality
Changes in Functional cognitive assessment scale (FUCAS) score
Measured: baseline, 12 and 24 months
Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Letter \& Category Fluency Test
Measured: baseline, 12 and 24 months
CDR- Measurements to Assess General Cognitive Function
Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)
Measured: baseline, 12 and 24 months
MoCA- Measurements to Assess General Cognitive Function
Changes in Montreal Cognitive Assessment (MoCA)
Measured: baseline, 12 and 24 months
CANTAB- Measurements to Assess General Cognitive Function
Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: baseline, 12 and 24 months
Clock Drawing test- Measurements to Assess General Cognitive Function
Changes in the Clock Drawing test
Measured: baseline, 12 and 24 months
Logical Memory test- Measurements to Assess General Cognitive Function
Changes in the Logical Memory test
Measured: baseline, 12 and 24 months
Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
Changes in the Digit Span Forward \& Backward test
Measured: baseline, 12 and 24 months
WAIS-R Digit Symbol- Measurements to Assess General Cognitive Function
Changes in the WAIS-R Digit Symbol Substitution Test
Measured: baseline, 12 and 24 months
TMT part A and B- Measurements to Assess General Cognitive Function
Changes in the Trail Making Test
Measured: baseline, 12 and 24 months
ADASCog-Measurements to Assess Daily Functionality
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
Measured: baseline, 12 and 24 months
Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
Changes in Functional Rating Scale for Dementia (FRSSD)
Measured: baseline, 12 and 24 months
Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Auditory Verbal Learning Test
Measured: baseline, 12 and 24 months
Boston Naming Test- Measurement to Assess Verbal Fluency and Learning
Changes in the Boston Naming Test
Measured: baseline, 12 and 24 months
Secondary outcomes (5)
NeuroImaging
Changes in brain Magnetic Resonance Imaging (MRI) 1.5 Tesla (brain atrophy) [Time Frame: baseline, 24 month]
Measured: baseline and 24 months
CSF - beta amyloid
Changes in mean values on high sensitivity beta-amyloid 1-42 protein
Measured: baseline and 24 months
CSF TAU-protein
Changes in mean values on TAU-protein in cerebrospinal fluid
Measured: baseline and 24 months
Neurophysiology and ERPs
•Changes in Event-Related Potential (ERP) (oddball paradigm, auditory ERPs) [Time frame: baseline, 12 month, 24 month]
Measured: baseline, 12 and 24 months
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]
Measured: baseline, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start9 Nov 2016
- Primary completion15 Feb 2018 (estimated)
- Study completion15 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greek Alzheimer's Association and Related Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magda Tsolaki, Professor, Principal investigator, Greek Alzheimer's Association and Related Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362996
- Sponsor's protocol ID
- 25/201614
- Acronym
- MICOIL
- Status last verified
- Jan 2018
- First submitted
- 3 Nov 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not available at this stage
Publications
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.
PubMed 27472878Tzekaki 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.
PubMed 34748951Tzekaki 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.
PubMed 33836262
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03362996
- Acronym / sponsor ID
- MICOIL / 25/201614
- Conditions
- Mild Cognitive Impairment
- Keywords
- extra virgin olive oil, mild cognitive impairment, randomized double blind clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Greek Alzheimer's Association and Related DisordersUniversity, hospital or other
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 15 Feb 2018 (estimated)
- Study completion
- 15 May 2019 (estimated)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Freshly-Pressed Extra Virgin Olive Oil50 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) |
| Control group 1 | Placebo comparator | Combination Product: extra virgin olive oil50 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) |
| Control Group 2 | Other | Other: mediterranean diet50 patients that will have the same dietary habits and a Mediterranean dietary protocol |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freshly-Pressed Extra Virgin Olive OilDietary 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 | Dietary supplement | Experimental Group |
| extra virgin olive oilExtra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days | Combination product | Control group 1 |
| mediterranean diet50 patients that will have the same dietary habits and a Mediterranean dietary protocol | Other | Control Group 2 |
Primary outcome
Neuropsychological Assessment- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in Mini-Mental State Examination (MMSE) score
FUCAS-Measurements to Assess Daily Functionality
Time frame: baseline, 12 and 24 months
Changes in Functional cognitive assessment scale (FUCAS) score
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
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)
MoCA- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in Montreal Cognitive Assessment (MoCA)
CANTAB- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in Cambridge Neuropsychological Test Automated Battery (CANTAB)
Clock Drawing test- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the Clock Drawing test
Logical Memory test- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the Logical Memory test
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
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
TMT part A and B- Measurements to Assess General Cognitive Function
Time frame: baseline, 12 and 24 months
Changes in the Trail Making Test
ADASCog-Measurements to Assess Daily Functionality
Time frame: baseline, 12 and 24 months
Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog)
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)
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
Boston Naming Test- Measurement to Assess Verbal Fluency and Learning
Time frame: baseline, 12 and 24 months
Changes in the Boston Naming Test
5 secondary outcomes
NeuroImaging
Time frame: baseline and 24 months
CSF - beta amyloid
Time frame: baseline and 24 months
CSF TAU-protein
Time frame: baseline and 24 months
Neurophysiology and ERPs
Time frame: baseline, 12 and 24 months
Electroencephalography recording
Time frame: baseline, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Background: PubMed 27472878Tsolaki 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.
- Derived from this study: PubMed 34748951Tzekaki 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.
- Derived from this study: PubMed 33836262Tzekaki 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.
- Individual participant dataSharing planned: Undecided. Not available at this stage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Tsolaki, Professor principal investigator
Greek Alzheimer's Association and Related Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Freshly-Pressed Extra Virgin Olive Oil, extra virgin olive oil and mediterranean diet in people with Mild Cognitive Impairment, run by Greek Alzheimer's Association and Related Disorders at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magda Tsolaki, Professor (0030 2310 2411 56, tsolakim1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Assessment- Measurements to Assess General Cognitive Function (time frame: baseline, 12 and 24 months). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03362996, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.