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

NCT06275243 | Completed DMC

• 1 other identifier: ETICA-ULE-021-2022
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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?

Conditions

Alzheimer Disease

Keywords

Alzheimer's disease; ApoE polymorphism; Geographical distribution; Cardiovascular factors; Total cholesterol

Outcome Measures

Primary Outcomes (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.

  9 months

Secondary Outcomes (2)

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

  9 months

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

  9 months

Study Arms (2)

Group of cases diagnosed with Alzheimer's disease

ACTIVE COMPARATOR

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

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 disease

SHAM COMPARATOR

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

Diagnostic Test: Kit Buccal swab collection & stabilization de Canvax®; Other: Assessing cardiovascular risk factors in all participants

Interventions

Kit Buccal swab collection & stabilization de Canvax® DIAGNOSTIC_TEST

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

Control group of healthy individuals without a diagnosis of Alzheimer's disease; Group of cases diagnosed with 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.

Group of cases diagnosed with Alzheimer's disease

Assessing cardiovascular risk factors in all participants 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; Group of cases diagnosed with Alzheimer's disease

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de León: lead
• Consejo General de Colegios Oficiales de Enfermería España: collaborator

Study Sites (1)

University of León

León, 240071, Spain

Location

Related Publications (7)

• 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.

  PMID: 28085496 BACKGROUND

• 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.

  PMID: 14578332 BACKGROUND

• 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.

  PMID: 24502694 BACKGROUND

• 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.

  PMID: 20734437 BACKGROUND

• 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.

  PMID: 19906263 BACKGROUND

• 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.

  PMID: 27470930 BACKGROUND

• 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.

  PMID: 33375167 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor in University of León

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 23, 2024
• Study Start: July 6, 2022
• Primary Completion: March 13, 2023
• Study Completion: March 22, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)