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Clinical Trials/NCT06275243
NCT06275243
Completed
Not Applicable

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

Universidad de León1 site in 1 country511 target enrollmentJuly 6, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Universidad de León
Enrollment
511
Locations
1
Primary Endpoint
Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon.
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 6, 2022
End Date
March 22, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad de León
Responsible Party
Principal Investigator
Principal Investigator

Leticia Sánchez Valdeón

Assistant Professor Doctor in University of León

Universidad de León

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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