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

May 6, 2024 updated by: Leticia Sánchez Valdeón, Universidad de León

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

511

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • León, Spain, 240071
        • University of León

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group of cases diagnosed with Alzheimer's disease
Participants: Men and women with age between 60 and 90 years
Diagnostic test: Kit Buccal swab collection & stabilization de Canvax®
Assessment of ApoE variant in saliva samples as a potential biomarker for Alzheimer's disease.
Other: Cholesterol levels according to ApoE Genotype
Enhancing the quality of life of study participants by investigating cholesterol levels based on their ApoE genotype.
Other: Assessing cardiovascular risk factors in all participants
Through individual interviews, record cardiovascular factors and assess their correlation with Alzheimer's disease.
Sham Comparator: Control group of healthy individuals without a diagnosis of Alzheimer's disease
Participants: Men and women with age between 60 and 90 years
Diagnostic test: Kit Buccal swab collection & stabilization de Canvax®
Assessment of ApoE variant in saliva samples as a potential biomarker for Alzheimer's disease.
Other: Assessing cardiovascular risk factors in all participants
Through individual interviews, record cardiovascular factors and assess their correlation with Alzheimer's disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de León

Collaborators

Consejo General de Colegios Oficiales de Enfermería España

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2022

Primary Completion (Actual)

March 13, 2023

Study Completion (Actual)

March 22, 2024

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 16, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETICA-ULE-021-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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