Management of Dementia With Olive Oil Leaves - GOLDEN
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:
- 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
- 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.
- 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.
- 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
- 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
- 否
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
Magda Tsolaki
MD Professor ,Greek Alzheimer's Association and Related Disorders
Aristotle University Of Thessaloniki
