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Polymorphism of ApoE in Alzheimer's Disease: Genetic Study in Castile and Leon (Spain)

Alzheimer's Disease as a Sociosanitary Priority: ApoE Gene Polymorphism

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06275243
Enrollment
511
Registered
2024-02-23
Start date
2022-07-06
Completion date
2024-03-22
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease, ApoE polymorphism, Geographical distribution, Cardiovascular factors, Total cholesterol

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.

Interventions

DIAGNOSTIC_TESTKit Buccal swab collection & stabilization de Canvax®

Assessment of ApoE variant in saliva samples as a potential biomarker for Alzheimer's disease.

OTHERCholesterol levels according to ApoE Genotype

Enhancing the quality of life of study participants by investigating cholesterol levels based on their ApoE genotype.

OTHERAssessing cardiovascular risk factors in all participants

Through individual interviews, record cardiovascular factors and assess their correlation with Alzheimer's disease.

Sponsors

Consejo General de Colegios Oficiales de Enfermería España
CollaboratorUNKNOWN
Universidad de León
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

It is a longitudinal randomised clinical study, in which two study groups were used. A group of cases diagnosed with Alzheimer's disease and a control group of healthy individuals without Alzheimer's disease.

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon.9 monthsThe 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

MeasureTime frameDescription
Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects.9 monthsWe 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.
ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon.9 monthsTo assess the presence of significant differences in the mean cholesterol values across different genotypes, an analysis of variance (ANOVA) test will be applied.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026