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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-06

Study Completion Date

2024-03-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Group of cases diagnosed with Alzheimer's disease

Participants: Men and women with age between 60 and 90 years

Group Type ACTIVE_COMPARATOR

Kit Buccal swab collection & stabilization de Canvax®

Intervention Type DIAGNOSTIC_TEST

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

Cholesterol levels according to ApoE Genotype

Intervention Type 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

Intervention Type OTHER

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

Control group of healthy individuals without a diagnosis of Alzheimer's disease

Participants: Men and women with age between 60 and 90 years

Group Type SHAM_COMPARATOR

Kit Buccal swab collection & stabilization de Canvax®

Intervention Type DIAGNOSTIC_TEST

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

Assessing cardiovascular risk factors in all participants

Intervention Type OTHER

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

Interventions

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Kit Buccal swab collection & stabilization de Canvax®

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

Intervention Type DIAGNOSTIC_TEST

Cholesterol levels according to ApoE Genotype

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

Intervention Type OTHER

Assessing cardiovascular risk factors in all participants

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes