Clinical trial NCT04440020: Management of Dementia With Olive Oil Leaves - GOLDEN
Official title: Management of Dementia With Olive Oil Leaves - GOLDEN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prevention
Keywords: olive oil tree
leaves
Mild Dementia
prevention
Alzheimer's disease
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Participant
Primary purpose: PREVENTION

Brief summary: Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc).The olive leaves contain several phenolic compounds, most important of which are oleo-European and hydroxytyrosol. The properties of the olive leaves have been attributed mainly to these two substances.

Detailed description: Mild Dementia (Mild Dementia) is a state of mind disorder (memory, reason, attention, concentration, time orientation) with difficulty in the complex activities of everyday life (bank accounts, shopping, transportation, etc)

The olive leaves contain several phenolic compounds, most important of which are oleo-European and hydroxytyrosol. The properties of the olive leaves have been attributed mainly to these two substances. The benefits of eating olive leaves (juice, snack) are summarized as follows:

1. Strengthen the immune system. It is the predominant benefit of drinking olive juice or beverage because of its active ingredient, oleo-European. Multi-pathogenic efficacy can be beneficial in treating influenza viruses, herpes simplex has been pathogenetically linked to Alzheimer's disease, yeasts (Yeast Syndrome), bacteria (11 species). Spectacular results have also been reported in the treatment of acute symptoms of AIDS by the administration of olive leaves. Also, neuroinflammation is one of the pathological mechanisms of Alzheimer's Disease
2. Antioxidant action. Inhibition of oxidation of LDL cholesterol, caused by olive leaf oil, reduces the risk of developing cardiovascular disease. The simultaneous presence of "antioxidant" vitamin E that is abundant in olive leaves, further enhances this action. Oxidative stress is a proven causative factor for Alzheimer's disease.
3. Antihypertensive action. Since the 1950s, there have been clinical data on the use of olive leaves in the treatment of hypertension through their vasodilatory action. One of the environmental risk factors for Alzheimer's Disease is also Hypertension.
4. Inhibition of platelet aggregation. This property turns olive leaves into a major weapon for treating cardiovascular events and avoiding dangerous thrombi. Vascular cerebral or cardiac events are also vascular environmental factors of Alzheimer's Disease
5. Increase in energy - Treatment of chronic fatigue. Consumption of olive leaves has been reported by many patients, but also by healthy people, that it gives more energy. This greater potency, potentially, can increase performance at work, performance in sport. Also, many cases of rapid recovery from chronic fatigue with frequent and systematic consumption of olive leaves have been reported. In short, they are a very important tool for modern and stressed man, the need for wellness and longevity.

One can easily observe the richness of olive leaves in trace elements, minerals - the role of Fe, Cu, Zn, Al and Hg in Alzheimer's disease is very important - and vitamins, making them a valuable nutritional tool for humans. At the same time, their fatty acid (saturated, monounsaturated, polyunsaturated) ratio is ideal and indicates their cardioprotective and neuroprotective properties.

The presence of vitamin E is twice as high as that found in a proportion of sesame oil (4.1 mg / 100gr), making the olive leaves a food rich in that vitamin. As far as iron is concerned, its presence is greater than the corresponding presence of breakfast cereals (8.2mg / 100gr), so advertised as a complete and quality food for the modern man.

Finally, particular reference should be made to the dietary fiber of the olive leaves. The dietary fiber is found in this food in abundance, making it a food that helps in the multifactorial treatment of constipation.

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 18-24
* CDR(sum of boxes) \>= 0,5
* Diagnosis: Mild Dementia (Alzheimer's Dementia)
* Geriatric Depression Scale (GDS) \<6
* Hachinski Modified Ischemic scale \<= 4
* Stability of Permitted Medications for 4 weeks
* Years of education: \>= 5
* Proficient language fluency
* 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

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).

Primary outcomes:
measure: Neuropsychological Assessment - Measurements to Assess General Cognitive Function
timeFrame: baseline,24 months
measure: FUCAS-Measurements to Assess Daily Functionality
timeFrame: baseline,24 months
measure: Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning
timeFrame: baseline,24 months
measure: CDR- Measurements to Assess General Cognitive Function
timeFrame: baseline,24 months
measure: MoCA- Measurements to Assess General Cognitive Function
timeFrame: baseline,24 months
measure: Clock Drawing test- Measurements to Assess General Cognitive Function
timeFrame: baseline,24 months
measure: Logical Memory test- Measurements to Assess General Cognitive Function
timeFrame: baseline, 24 months
measure: Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function
timeFrame: baseline,24 months
measure: WAIS-R (Wechler Adult Intelligence scele) Digit Symbol- Measurements to Assess General Cognitive Function
timeFrame: baseline,24 months
measure: TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function
timeFrame: baseline, 24 months
measure: ADASCog-Measurements to Assess Daily Functionality
timeFrame: baseline, 24 months
measure: Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality
timeFrame: baseline, 24 months
measure: Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning
timeFrame: baseline,24 months
Secondary outcomes:
measure: NeuroImaging
timeFrame: baseline,24 months
measure: CSF - beta amyloid
timeFrame: baseline,24 months
measure: CSF(cerebrospinal fluid) TAU-protein ( soluble protein)
timeFrame: baseline,24 months
measure: Electroencephalography recording
timeFrame: baseline,24 months
Other outcomes:
measure: Weight in Kilograms
timeFrame: baseline,24 months
measure: Height in Meters
timeFrame: baseline,24 months
Locations:
city: Thessaloniki
country: Greece
facility: Greek Associoation of Alzheimer'S Disease and Related Disorders
Study officials:
References:
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.
citation: Tzekaki EE, Tsolaki M, Pantazaki AA, Geromichalos G, Lazarou E, Kozori M, Sinakos Z. Administration of the extra virgin olive oil (EVOO) in mild cognitive impairment (MCI) patients as a therapy for preventing the progress to AD. Hell J Nucl Med. 2019 Sep-Dec;22 Suppl 2:181.