Alzheimer's Disease as a Sociosanitary Priority: ApoE Gene Polymorphism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 511
- 试验地点
- 2
- 主要终点
- Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon.
研究概览
简要总结
The general objective of this randomized and longitudinal clinical study was to estimate the frequencies of ApoE variants both in the user population of the "Messengers of Peace" Residences and the "Associations of Relatives of Alzheimer's Patients" in Castile y Leon, since, due to its geographical location at the crossroads, it has received multiple genetic contributions from both northern Europe, the Mediterranean area and northern Africa.
The main questions it aims to answer are:
- What are the allelic frequencies of ApoE variants in the population of individuals with Alzheimer's disease in Castile and Leon?
- Is there a correlation between the ApoE4 variant and the lipid profile in the blood of individuals with Alzheimer's disease in this region?
详细描述
In the context of Alzheimer disease research, it is widely recognized that the ApoE gene plays a fundamental role in the genetic predisposition of this disease. With three major alleles: ApoE2, ApoE3, and ApoE4, genetic variability in the ApoE gene has been the subject of extensive attention in previous research and its association with increased risk of Alzheimer's disease has remained consistent. Within this framework, three hypotheses are proposed focused on understanding the specific influence of ApoE on Alzheimer's disease and exploring the possible underlying mechanisms.
Within this framework, three hypotheses are proposed focused on understanding the specific influence of ApoE on Alzheimer disease and exploring the possible underlying mechanisms:
- - Research hypotheses: The genetic variant ApoE4/4 is significantly related to a higher risk of developing Alzheimer's disease compared to individuals who do not carry this genotype.
- - Research hypotheses: The ApoE2/2 genetic variant is associated with a lower risk of developing Alzheimer's disease compared to other genotypes.
- - Research hypotheses: People who carry the ApoE4 isoform have elevated levels of total cholesterol and LDL-cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be between 60 and 90 years old.
- •Subjects with a diagnosis of AD in the case group.
- •Subjects free of AD diagnosis in the control group.
- •Subjects who voluntarily and consented to participate free of charge.
- •Have completed the written consent
排除标准
- •Subjects who, at the time of sample collection, had behavioral or other alterations that made the sample collection procedure impossible.
- •Subjects who, at the time of sample collection, presented oral alterations incompatible with the technique.
结局指标
主要结局
Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon.
时间窗: 9 months
The saliva samples will be processed to purify and extract DNA. Subsequently, a PCR amplification will be performed to check the ApoE alleles and genotypes.
次要结局
- ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon.(9 months)
- Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects.(9 months)
研究者
Leticia Sánchez Valdeón
Assistant Professor Doctor in University of León
Universidad de León