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Completed

NCT Number: NCT06275243

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

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?

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of León

León, 240071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kit Buccal swab collection & stabilization de Canvax®

Diagnostic Test

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

Cholesterol levels according to ApoE Genotype

Other

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

Assessing cardiovascular risk factors in all participants

Other

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

Primary outcomes

  1. Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon.

    Time frame: 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 outcomes

  1. Cardiovascular factors in individuals with Alzheimer's disease and healthy subjects.

    Time frame: 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.

  2. ApoE genotypes and cholesterol levels in the Alzheimer's disease population diagnosed in Castile and Leon.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad de León

Other

Collaborators

  • Consejo General de Colegios Oficiales de Enfermería España

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 23, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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