Influence of Oxidative Stress and Nutrition Biomarkers on the Cognitive Decline Evolution in Alzheimer Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.
研究概览
简要总结
According to several reports, the oxidative stress and the nutrition could have an impact in the Alzheimer disease.
The association of these two parameters measurements and the cognitive impairment decline could help in a predictive diagnosis of cognitive decline evolution in patients presenting cognitive disorders.
This is a monocentric prospective "routine care" clinical trial on patients showing cognitive troubles especially memory complaints.
The objective is to demonstrate a correlation between oxydative stress and nutrition biomarkers and the clinical evolution of patients complaining of cognitive impairments.
The neuropsychologic data collection (the mini mental Status Examination (MMSE), the clock test, the Grober-Buschke test (FCSR-IR), the executive function evaluated by the Trail making test, and the medical imaging (by magnetic resonance imaging (MRI) or tomography in case of MRI contraindication) will be realized during the study inclusion phase in the usual intake of patients. Whole blood samples for the oxydative and nutrition biomarkers measurements will be taken at the study inclusion day during the stay at the Day hospital dedicated to the routine intake of patients issued from the memory consultation.
In this study, the principal evaluation criteria will be the MMSE score evolution during the 60 months of the patients follow-up, measured during the routine visits scheduled approximately every 6 months, according to the french national authority for health recommendations. It will allow evaluating the correlation between the cognitive decline evolution measured by MMSE during the Alzheimer disease or related diseases method during the 2 years follow-up, and the oxydative stress blood markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>55 years old patient
- •Patient seen during a memory consultation in geriatric Unit, Lyon Sud University Hospital
- •Patient or legal representative and/or person of confidence who didn't express his opposition to the clinical assay participation.
- •Patient registered to the general social insurance
- •Complementary health check scheduled at day hospital, conventional hospitalization or regular consultation.
排除标准
- •Patient unable to express his participation refusal and under curatorship or unforced by the court of justice
结局指标
主要结局
Change (evolution) of patient's cognitive profile evaluation measured by MMSE score method during memory consultation follow-up, every 6 months until patient loss.
时间窗: at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months
Patient cognitive profile evolution measured by successive MMSE score evaluations during follow-up memory consultation, every 6 months until patient loss.
次要结局
- Functionality(at baseline (day 0) and at day hospital visit if need be (up to 48 months))
- cognitive profile evaluation at inclusion phase(at baseline (day 0))
- Présence of cardiovascular risk factor(at baseline (day 0))
- Presence of anomalies on cerebral imaging data that evoke neuro-degenerative pathology, by MRI(At day hospital visit if need be (up to 48 months))
- treatment evaluation(at baseline (day 0) and at 6, 12, 18, 24, 30, 36, 42, 48 months)