Randomized, Double Blind, Placebo Controlled Prospective Study, to Evaluate the Effect of a Vegetal Oil in the Disease's Natural Evolution in Patients Diagnosed With Cognitive Impairment or Mild to Moderate Alzheimer Disease.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Changes in Global Clinical Dementia Rating (CDR) score
研究概览
简要总结
The aim of the study is to evaluate the beneficial effect of a mixture of vegetal oils with a composition related to short, medium and long unsaturated chain fatty acids on patients with a diagnose of cognitive impairment or mild to moderate Alzheimer disease
详细描述
The cognitive impairment syndrome is defined as a decrease of the intellectual performance with respect to a previous step in time. The Cognitive impairment has to be considered as a functional alteration with a continuous and physiological evolution in which happen a set of different circumstances:
- A increasing and normal reduction, that appears after the age of sixty, also known as Age-associated memory impairment (AAMI)
- A mild cognitive impairment (MCI), with a recent and mild loss of memory, but higher to that expected because of patient's age and educational level.
- A severe pathological decrease of the mental abilities, also known as, depending on its characteristics: Severe cognitive impairment (SCI), senile dementia and Alzheimer's disease (1).
In the next years it is expected that this disease will become one of the main health and aged-related problem in aged people.(2) Nowadays, there are 35,6 million people with any kind of dementia, and it is estimated that every year, 7,7 million of new patients are diagnosed. (3) The amount of people affected will probably duplicate every 20 years, if effective treatments to stop its evolution are not developed. The forecast estimate up to 81,1 million of patients in 2040, which make this disease in a XXI century real epidemic.(4)
Before reaching the level of dementia, SCI or Alzheimer's disease, the patient will suffer a progressive mild cognitive impairment. In this level, the disease can be early diagnosed and it would be worth to act on it.
Evidences of the Polyunsaturated oils use on the prevention and/or treatment of cognitive impairment.
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
- Double (Participant, Investigator)
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
- •informed consents signed by patients and/or caretaker
- •The patient has to fulfil dementia clinical criteria.
- •Age between 55 and 85 years old.
- •MMSE score between 18 and
- •The patient can fulfil all neuropsychologic test, according to investigator.
- •The patient has to be always with his/her caretaker during monitorization visits
- •The caretaker has to be in regular contact with the patient, knowing his/her situation and participation in the study.
- •The caretaker has to check four times per week, at least, the product intake, as well as the routine medication and his/her dietetic habits.
- •Both caretaker and patient have to be able to complete the product intake during all the length of the study, according to the main investigator.
排除标准
- •Patient and/or caretaker not being able to understand and agree in writing their participation in the study.
- •Patient disability to oral intake of products.
- •Known allergy to any of the product components (active and placebo)
- •Evidence of suffering other neuropsychiatric disturbances apart of dementia as: Parkinson disease, psychotic disturbance, bipolar depression.
- •regular intake of alcohol higher than 45 g ethanol/day, during the year before study inclusion.
- •Any known concurrent malignant pathology in the moment of study inclusion, or severe metabolic, cardiovascular, renal, hepatic, or gastrointestinal disease that cannot allow the ending of the study according the investigator.
- •Any analytical abnormality during the screening, apart from: Creatinine no less than 1.7 mg/dL; low levels of Vitamin B12, and TSH abnormal values.
结局指标
主要结局
Changes in Global Clinical Dementia Rating (CDR) score
时间窗: baseline, 3 month, 6 month, 9 month, 12 month
Changes in Mini-Mental State Examination (MMSE) score
时间窗: baseline, 3 month, 6 month, 9 month, 12 month
次要结局
- Changes in systemic oxidative parameters in periferic blood samples (Nitric Oxyde)(baseline, 12 month)
- Changes in systemic oxidative parameters in periferic blood samples (Malondialdehyde (MDA))(baseline, 12 month)
- Changes in beta-amyloid protein concentration(baseline, 12 month)
- Changes in TAU-Protein concentration(baseline, 12 month)
- Changes in regular treatment for the cognitive impairment(baseline, 3 month, 6 month, 9 month, 12 month)
- Changes in dietetic habits(baseline, 3 month, 6 month, 9 month, 12 month)
- Changes in Barthel score(baseline, 3 month, 6 month, 9 month, 12 month)
- Changes in Morisky-Green score(baseline, 3 month, 6 month, 9 month, 12 month)
- changes in weight(baseline, 3 month, 6 month, 9 month, 12 month)
- Number of adverse events(baseline, 3 month, 6 month, 9 month, 12 month)