Use of Human Blood Cells for the Identification of Early Biomarkers of Cognitive Damage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Body composition (fat mass)
研究概览
简要总结
The aim of this study is to identify transcriptomic biomarkers in blood cells to diagnose early cognitive impairment. This would allow preventing the development of severe pathologies, such as Alzheimer Disease. In addition, this project will analyse the influence of adiposity, obesity, nutritional habits and physical activity on cognition.
详细描述
Blood cells constitute a minimally invasive material, which is presented as potentially suitable for addressing the identification of clinical diagnostic biomarkers. This study will compare gene expression in blood cells of patients with various degrees of cognitive alteration (mild cognitive impairment due to Alzheimer's disease and dementia due to Alzheimer's Disease) compared to control individuals, to identify early biomarkers of impaired cognition. The availability of non-invasive early biomarkers of cognitive dysfunction is highly relevant in the field of public health, from the point of view of being able to prevent or delay the onset and/or progression of dementia and other cognitive disorders. In addition, it is intended to establish the association between the biomarkers identified with nutritional imbalances and increased adiposity/obesity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Body composition (fat mass)
时间窗: Baseline point (all groups)
Percentage of fat mass measured using a dual energy x-ray absorptiometry (DXA) scanner
Percentage of semiquantitative gene expression of blood cells between the three groups
时间窗: Baseline point (all groups)
Gene expression analysis performed by real-time quantitative polymerase chain reaction (RT-qPCR). Percentage of semiquantitative gene expression between the groups: MCI vs Control, AD vs Control, and MCI vs AD
Mini-Mental State Examination (MMSE), questionnaire (numerical scale)
时间窗: Baseline point (all groups)
Cognitive test
Montreal Cognitive Assessment (MoCA), questionnaire (numerical scale)
时间窗: Baseline point (all groups)
Cognitive test
Cognitive Reserve Questionnaire (CRIq), questionnaire (numerical scale)
时间窗: Baseline point (all groups)
Cognitive test
次要结局
- Height (cm)(Baseline point (all groups))
- Waist-hip ratio (numerical ratio)(Baseline point (all groups))
- Blood pressure (mm Hg)(Baseline point (all groups))
- Weight (kg)(Baseline point (all groups))
- Body Mass Index (BMI) (kg/m2)(Baseline point (all groups))
- Complete blood count test (numbers of cells/mcL)(Baseline point (all groups))
- Plasma glucose (mg/dL)(Baseline point (all groups))
- Triglycerides (TG, mg/dL)(Baseline point (all groups))
- Total cholesterol (mg/dL)(Baseline point (all groups))
- High-density lipoprotein cholesterol (HDL-C,mg/dL)(Baseline point (all groups))
- Low-density lipoprotein cholesterol (LDL-C, mg/dL)(Baseline point (all groups))
- Aspartate aminotransferase (AST, U/L)(Baseline point (all groups))
- Alanine aminotransferase (ALT, U/L)(Baseline point (all groups))
- Gamma-glutamyl transpeptidase (GGT, U/L)(Baseline point (all groups))
- Transpeptidase (GGT, U/L)(Baseline point (all groups))
- C-reactive protein (CRP, mg/dL)(Baseline point (all groups))
- Apolipoprotein E (APOE, mg/dL)(Baseline point (all groups))
- Glycated hemoglobin (HbA1c, %)(Baseline point (all groups))
- Test on nutritional habits, questionnaire (numerical scale)(Baseline point (all groups))
- International Physical Activity Questionnaire, IPAQ (numerical scale)(Baseline point (all groups))
- STOP-BANG Sleep Apnea Questionnaire (numerical scale)(Baseline point (all groups))
- Gait Speed Test (m/s)(Baseline point (all groups))