Cerebrovascular Correlates of Dementia in Rural Communities - The Three Villages Study

NCT ID: NCT04123171

Last Updated: 2019-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2024-06-30

Brief Summary

This study aims to assess the prevalence and severity of dementia in an established cohort of community-dwelling older adults living in three neighboring rural Ecuadorian villages (Atahualpa, El Tambo, and Prosperidad), as well as to evaluate clinical and neuroimaging correlates of dementia in the study population. By the use of the Clinical Dementia Rating Scale (CDRS), the study also aims to assess the lower cutoff of the MoCA that better correlates with the occurrence of dementia in the study population. In addition, this study will provides grounds for the initiation of a prospective cohort study to assess factors influencing the development of dementia in the follow-up.

Detailed Description

The Three Villages Study is a population-based prospective cohort study designed to reduce the increasing burden of cognitive decline and dementia in rural Ecuador. Before the study, our Executive Committee met with community leaders to explain the aims of the study and to learn about the culture and traditions of villagers. Field personnel were trained to assure uniformity in data collection. With the aid of satellite view (Google Earth, Google Inc., Mountain View, CA), updated sketches of the villages were performed to identify blocks and houses.

The study initially will follow a 3-Phase cross-sectional design. During Phase I, Atahualpa, El Tambo, and Prosperidad residents aged 60 years or more will be identified by means of a door-to-door survey and interviewed with validated questionnaires to identify those with relevant risk factors and suspected conditions of interest. In Phase II, certified neurologists will examine suspected cases as well as random samples of negative individuals, to assess reliability of field instruments and to determine prevalence of the investigated conditions. In Phase III, enrolled individuals will be invited to undergo complementary tests. Thereafter, incoming residents will be recruited and followed-up by means of yearly door-to-door surveys and other overlapping sources to estimate incidence of the disorders of interest.

Conditions

Dementia; Cardiovascular Risk Factor; Atherosclerosis; Cerebral Small Vessel Diseases; Cognitive Decline

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The Three Villages Cohort

Individuals aged 60 years or more identified by means of door-to-door surveys, living in Atahualpa, El Tambo, and Prosperidad. Individuals will be interviewed with validated field instruments, and there will be invited for the practice of complementary exams to recognize markers of aterosclerosis and cerebral small vessel disease.

Neuroimaging studies

Intervention Type: DIAGNOSTIC_TEST

Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form

Interventions

Neuroimaging studies

Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Ultrasound examinations; Ankle-brachial index determinations

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Especialidades Espiritu Santo

OTHER

Sponsor Role: lead

Responsible Party

Oscar H. Del Brutto

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Especialidades Espiritu Santo

Samborondón, Guayas, Ecuador

Site Status: RECRUITING

Community Center

Atahualpa, Santa Elena, Ecuador

Site Status: RECRUITING

Countries

Ecuador

Facility Contacts

Oscar H Del Brutto, MD

Role: primary

odelbrutto@uees.edu.ec

593-997476984

Bettsy Y Recalde, MD

Role: backup

bettsyr@hotmail.es

59342907332

Bettsy Y Recalde, MD

Role: primary

bettsyr@hotmail.com

59342907332

References

Del Brutto OH, Penaherrera E, Ochoa E, Santamaria M, Zambrano M, Del Brutto VJ; Atahualpa Project Investigators. Door-to-door survey of cardiovascular health, stroke, and ischemic heart disease in rural coastal Ecuador--the Atahualpa Project: methodology and operational definitions. Int J Stroke. 2014 Apr;9(3):367-71. doi: 10.1111/ijs.12030. Epub 2013 Mar 19.

Reference Type: RESULT

PMID: 23506643 (View on PubMed)

Del Brutto OH, Mera RM, Peralta LD, Hill JP, Generale LM, Torpey AP, Sedler MJ. Cardiovascular Health Status Among Community-Dwelling Ecuadorian Natives Living in Neighboring Rural Communities: The Three Villages Study. J Community Health. 2020 Feb;45(1):154-160. doi: 10.1007/s10900-019-00728-4.

Reference Type: RESULT

PMID: 31446542 (View on PubMed)

Del Brutto VJ, Ortiz JG, Del Brutto OH, Mera RM, Zambrano M, Biller J. Total cerebral small vessel disease score and cognitive performance in community-dwelling older adults. Results from the Atahualpa Project. Int J Geriatr Psychiatry. 2018 Feb;33(2):325-331. doi: 10.1002/gps.4747. Epub 2017 May 26.

Reference Type: RESULT

PMID: 28548298 (View on PubMed)

Del Brutto OH, Mera RM, Del Brutto VJ, Sedler MJ. The bicaudate index inversely associates with performance in the Montreal Cognitive Assessment (MoCA) in older adults living in rural Ecuador. The Atahualpa project. Int J Geriatr Psychiatry. 2016 Aug;31(8):944-50. doi: 10.1002/gps.4419. Epub 2016 Feb 2.

Reference Type: RESULT

PMID: 26833914 (View on PubMed)

Del Brutto OH, Mera RM, Castillo PR, Del Brutto VJ. Key findings from the Atahualpa Project: what should we learn? Expert Rev Neurother. 2018 Jan;18(1):5-8. doi: 10.1080/14737175.2018.1400382. Epub 2017 Nov 6. No abstract available.

Reference Type: RESULT

PMID: 29088979 (View on PubMed)

Other Identifiers

201901UEES

Identifier Type: -

Identifier Source: org_study_id