Polymorphism of ApoE in Alzheimer's Disease: Genetic Study in Castile and Leon (Spain)
- Conditions
- Alzheimer Disease
- Interventions
- Diagnostic Test: Kit Buccal swab collection & stabilization de Canvax®Other: Cholesterol levels according to ApoE GenotypeOther: Assessing cardiovascular risk factors in all participants
- Registration Number
- NCT06275243
- Lead Sponsor
- Universidad de León
- Brief Summary
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?
- Detailed Description
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:
1. - 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.
2. - Research hypotheses: The ApoE2/2 genetic variant is associated with a lower risk of developing Alzheimer's disease compared to other genotypes.
3. - Research hypotheses: People who carry the ApoE4 isoform have elevated levels of total cholesterol and LDL-cholesterol.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group of cases diagnosed with Alzheimer's disease Cholesterol levels according to ApoE Genotype Participants: Men and women with age between 60 and 90 years Control group of healthy individuals without a diagnosis of Alzheimer's disease Kit Buccal swab collection & stabilization de Canvax® Participants: Men and women with age between 60 and 90 years Group of cases diagnosed with Alzheimer's disease Kit Buccal swab collection & stabilization de Canvax® Participants: Men and women with age between 60 and 90 years Group of cases diagnosed with Alzheimer's disease Assessing cardiovascular risk factors in all participants Participants: Men and women with age between 60 and 90 years Control group of healthy individuals without a diagnosis of Alzheimer's disease Assessing cardiovascular risk factors in all participants Participants: Men and women with age between 60 and 90 years
- Primary Outcome Measures
Name Time Method Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon. 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.
- Secondary Outcome Measures
Name Time Method ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon. 9 months To assess the presence of significant differences in the mean cholesterol values across different genotypes, an analysis of variance (ANOVA) test will be applied.
Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects. 9 months We will analyze whether there are significant differences between individuals with Alzheimer's disease and healthy subjects in terms of cardiovascular risk factors (Diabetes mellitus, cardiac pathology, hypercholesterolemia and high blood pressure) using the z-test for difference in proportions.
Trial Locations
- Locations (1)
University of León
🇪🇸León, Spain