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Alzheimer DiseaseNCT06275243

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

A study testing Kit Buccal swab collection & stabilization de Canvax®, Cholesterol levels according to ApoE Genotype and Assessing cardiovascular risk factors in all participants in people with Alzheimer Disease, run by Universidad de León at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
Kit Buccal swab collection & stabilization de Canvax®, Cholesterol levels according to ApoE Genotype and Assessing cardiovascular risk factors in all participants
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
511 participants
Where
1 siteSpain
Study dates
6 Jul 2022to 22 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University of León

    León, 240071

Other trials in Spain

About this study

Official title: 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?
Read the 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.
Being tested
Kit Buccal swab collection & stabilization de Canvax®, Cholesterol levels according to ApoE Genotype, Assessing cardiovascular risk factors in all participants
Keywords
Alzheimer's disease, ApoE polymorphism, Geographical distribution, Cardiovascular factors, Total cholesterol
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 GenotypeOther

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

  • Assessing cardiovascular risk factors in all participantsOther

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

Study groups in NCT06275243
Study groupRoleWhat they receive
Group of cases diagnosed with Alzheimer's diseaseActive comparatorParticipants: Men and women with age between 60 and 90 years
Receives: Diagnostic Test: Kit Buccal swab collection & stabilization de Canvax®; Other: Cholesterol levels according to ApoE Genotype; Other: Assessing cardiovascular risk factors in all participants
Control group of healthy individuals without a diagnosis of Alzheimer's diseaseSham comparatorParticipants: Men and women with age between 60 and 90 years
Receives: Diagnostic Test: Kit Buccal swab collection & stabilization de Canvax®; Other: Assessing cardiovascular risk factors in all participants

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 9 months

Secondary outcomes (2)

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

    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.

    Measured: 9 months

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

    To assess the presence of significant differences in the mean cholesterol values across different genotypes, an analysis of variance (ANOVA) test will be applied.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start6 Jul 2022
  3. Primary completion13 Mar 2023
  4. Study completion22 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275243
Sponsor's protocol ID
ETICA-ULE-021-2022
Status last verified
May 2024
First submitted
30 Jan 2024
Last updated
8 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alharbi KK, Syed R, Alharbi FK, Khan IA. Association of Apolipoprotein E Polymorphism with Impact on Overweight University Pupils. Genet Test Mol Biomarkers. 2017 Jan;21(1):53-57. doi: 10.1089/gtmb.2016.0190.

    PubMed 28085496

  • Pantelidis P, Lambert-Hammill M, Wierzbicki AS. Simple sequence-specific-primer-PCR method to identify the three main apolipoprotein E haplotypes. Clin Chem. 2003 Nov;49(11):1945-8. doi: 10.1373/clinchem.2003.021683. No abstract available.

    PubMed 14578332

  • Reales G, Hernandez CL, Dugoujon JM, Novelletto A, Cuesta P, Fortes-Lima C, Rodriguez JN, Calderon R. New insights into the distribution of APOE polymorphism in the Iberian Peninsula. The case of Andalusia (Spain). Ann Hum Biol. 2014 Sep-Oct;41(5):443-52. doi: 10.3109/03014460.2013.877966. Epub 2014 Feb 6.

    PubMed 24502694

  • Eisenberg DT, Kuzawa CW, Hayes MG. Worldwide allele frequencies of the human apolipoprotein E gene: climate, local adaptations, and evolutionary history. Am J Phys Anthropol. 2010 Sep;143(1):100-11. doi: 10.1002/ajpa.21298.

    PubMed 20734437

  • Reitz C, Mayeux R. Use of genetic variation as biomarkers for Alzheimer's disease. Ann N Y Acad Sci. 2009 Oct;1180:75-96. doi: 10.1111/j.1749-6632.2009.04945.x.

    PubMed 19906263

  • Salameh TS, Rhea EM, Banks WA, Hanson AJ. Insulin resistance, dyslipidemia, and apolipoprotein E interactions as mechanisms in cognitive impairment and Alzheimer's disease. Exp Biol Med (Maywood). 2016 Sep;241(15):1676-83. doi: 10.1177/1535370216660770. Epub 2016 Jul 28.

    PubMed 27470930

  • Gonzalez RD, Gomes I, Gomes C, Rocha R, Duraes L, Sousa P, Figueruelo M, Rodriguez M, Pita C, Hornero R, Gomez C, Lopes AM, Pinto N, Martins S. APOE Variants in an Iberian Alzheimer Cohort Detected through an Optimized Sanger Sequencing Protocol. Genes (Basel). 2020 Dec 22;12(1):4. doi: 10.3390/genes12010004.

    PubMed 33375167

Questions about this trial

What is this clinical trial studying?

A study testing Kit Buccal swab collection & stabilization de Canvax®, Cholesterol levels according to ApoE Genotype and Assessing cardiovascular risk factors in all participants in people with Alzheimer Disease, run by Universidad de León at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distribution of ApoE variants in the Alzheimer's disease population diagnosed in Castile and Leon. (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275243, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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