Effect of Treatment With EGb 761(r) on Blood Markers of Inflammation and Oxidative Stress in a Cohort of Patients With Mild Cognitive Impairment
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compare changes in blood marker levels of inflammation and oxidation
研究概览
简要总结
Mild Cognitive Impairment (MCI) is the moderate impairment of a mental abilities to perform intellectual activities eg memory, calculation, communication... MCI is a disorder that can occur earlier than dementia such as Alzheimer's disease. It is believed that there are several factors involved such as inflammation and oxidative stress which is the production of reactive oxygen species that damage cells.
This clinical study tries to evaluate that a treatment already approved by the AEMPS, EGb 761® (Tebofortan), could reduce the levels of markers of inflammation and oxidation in the blood.
详细描述
This treatment is based on a plant called Gingko Biloba. In the study, half of the participants would be administered EGb 761® during 24 months and the other half would not receive this treatment during 12 months and will received EGb 761® for the next 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for Mild Cognitive Impairment according to Petersen.
- •Global score Deterioration Scale (GDS)=3 and Clinical Dementia Rating (CDR)=0.
- •Subject's ability to comply with study requirements in the opinion of the investigator.
- •Informed consent signed
排除标准
- •Dementia (GDS=4-7) Severe auditory or visual abnormalities that could affect performance on neuropsychological tests.
- •Severe psychiatric pathology.
- •Hemorrhagic diathesis or anticoagulant treatment.
- •Active treatment with anticholinesterase drugs or memantine. History of epilepsy or alcoholism.
- •Galactose intolerance, malabsorption of glucose or galactose.
- •Previous treatment with EGb 761®.
研究组 & 干预措施
Arm 1
Treatment with EGb 761® (TEBOFORTAN 240 mg) during 24 months.
干预措施: TEBOFORTAN (Drug)
结局指标
主要结局
Compare changes in blood marker levels of inflammation and oxidation
时间窗: Between the baseline visit and follow-up visits at 6 and 12 months. All procedures in each of the visits will be carried out in a maximum period of 30 days.
To compare the changes in the levels of blood markers of inflammation and oxidation between the baseline visit and the follow-up visits at 6 and 12 months between the study group (patients with mild cognitive impairment who receive treatment with 1 daily tablet of EGb 761® 240 mg orally) and the control group (patients with the same clinical characteristics without treatment with EGb 761®). Blood markers of inflammation and oxidation: in v0 (baseline), v1 (6 month), v2 (12 month). The panel of inflammation markers from Olink proteomics (https://www.olink.com/products/inflammation/) will be used with 92 proteins associated with inflammatory diseases and related biological processes. The blood samples of the participants will be collected in the Fundació ACE Nursing Unit and sent to Olink proteomics for further analysis
次要结局
- Compare scores on neuropsychiatric tests(Between baseline visit and follow-up visit at 12 moths and follow-up visit at 24 months. All procedures in each of the visits will be carried out in a maximum period of 30 days.)
- Obtain data of changes in blood marker levels of inflammation and oxidative stress and security data(Between v0 (baseline), v1 (6 month), v2 (12 month), v3 (18 month), v4 (24 month) and in the Follow-up visit one month after the end of the treatment. All procedures in each of the visits will be carried out ina maximum period of 30 days.)
- Compare changes in cognitive test scores(Between baseline visit, follow-up visit at 12 moths and follow-up visit at 24 months. All procedures in each of the visits will be carried out in a maximum period of 30 days.)