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临床试验/NCT04440020
NCT04440020Unknown不适用

Management of Dementia With Olive Oil Leaves - GOLDEN

Aristotle University Of Thessaloniki2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Neuropsychological Assessment - Measurements to Assess General Cognitive Function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

single (participant)

入排标准

年龄范围
55 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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).

结局指标

主要结局

Neuropsychological Assessment - Measurements to Assess General Cognitive Function

时间窗: baseline,24 months

Changes in Mini-Mental State Examination (MMSE) score Score scale:0-30,cut off:24

Functional Rating Scale for Dementia-Measurements to Assess Daily Functionality

时间窗: baseline, 24 months

Changes in Functional Rating Scale for Dementia (FRSSD) Score scale:0-6,cut off:\>6

FUCAS-Measurements to Assess Daily Functionality

时间窗: baseline,24 months

Changes in Functional cognitive assessment scale (FUCAS) score Score scale:42-126,cut off:42

Letter & Category Fluency Test- Measurement to Assess Verbal Fluency and Learning

时间窗: baseline,24 months

Changes in the Letter \& Category Fluency Test

CDR- Measurements to Assess General Cognitive Function

时间窗: baseline,24 months

Changes in Global Clinical Dementia Rating (CDR) score (sum of boxes)

Digit Span Forward & Backward test- Measurements to Assess General Cognitive Function

时间窗: baseline,24 months

Changes in the Digit Span Forward \& Backward test

MoCA- Measurements to Assess General Cognitive Function

时间窗: baseline,24 months

Changes in Montreal Cognitive Assessment (MoCA)

Clock Drawing test- Measurements to Assess General Cognitive Function

时间窗: baseline,24 months

Changes in the Clock Drawing test

WAIS-R (Wechler Adult Intelligence scele) Digit Symbol- Measurements to Assess General Cognitive Function

时间窗: baseline,24 months

Changes in the WAIS-R Digit Symbol Substitution Test

TMT(Trail Making Test) part A and B- Measurements to Assess General Cognitive Function

时间窗: baseline, 24 months

Changes in the Trail Making Test

Logical Memory test- Measurements to Assess General Cognitive Function

时间窗: baseline, 24 months

Changes in the Logical Memory test

ADASCog-Measurements to Assess Daily Functionality

时间窗: baseline, 24 months

Changes in Alzheimer's Disease Assessment Scale-Cognitive (ADASCog) Score scale:0-70,cut off:\<15

Auditory Verbal Learning Test- Measurement to Assess Verbal Fluency and Learning

时间窗: baseline,24 months

Changes in the Auditory Verbal Learning Test

次要结局

  • CSF(cerebrospinal fluid) TAU-protein ( soluble protein)(baseline,24 months)
  • Electroencephalography recording(baseline,24 months)
  • NeuroImaging(baseline,24 months)
  • CSF - beta amyloid(baseline,24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Magda Tsolaki

MD Professor ,Greek Alzheimer's Association and Related Disorders

Aristotle University Of Thessaloniki

研究点 (2)

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