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

Cerebrovascular Correlates of Dementia in Community-dwelling Older Adults Living in Remote Rural Communities - The Three Villages Study. Methodology and Operational Definitions.

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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerosis; Dementia; Cerebral Small Vessel Diseases; Cognitive Decline; Cardiovascular Risk Factor
• Intervention / Treatment: Diagnostic test: Neuroimaging studies

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.

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Ecuador
  • Guayas
    • Samborondon, Guayas, Ecuador, 092301
      • Recruiting
      • Universidad de Especialidades Espiritu Santo
      • Contact: Oscar H Del Brutto, MD; Phone Number: 593-997476984; Email: odelbrutto@uees.edu.ec
      • Contact: Bettsy Y Recalde, MD; Phone Number: 59342907332; Email: bettsyr@hotmail.es
  • Santa Elena
    • Atahualpa, Santa Elena, Ecuador
      • Recruiting
      • Community center
      • Contact: Bettsy Y Recalde, MD; Phone Number: 59342907332; Email: bettsyr@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Atahualpa, el Tambo and Prosperidad are representative of rural villages of Coastal Ecuador, and were selected because they achieve several requisites to be considered optimal settings for the practice of epidemiological studies. The villages have a low index of migration rate. Inhabitants are homogeneous regarding race/ethnicity, lifestyles and diet, which is rich in oily fish. Residents are Ecuadorian natives with little evidence of cross-breading (Amerindians). Almost all men belong to the blue-collar class and most women are homemakers.

Description

Inclusion Criteria: Individuals aged 60 years of more residing in Atahualpa, El Tambo, and Prosperidad, who signed a comprehensive informed consent form.

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Exclusion Criteria: Severely disabled individuals in whom interviews and procedures cannot be performed

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Neuroimaging studies; Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form; Other Names: Ultrasound examinations; Ankle-brachial index determinations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the prevalence and severity of dementia in the study population	The Clinical Dementia Rating Scale will be applied to all participants	One year
To assess cerebrovascular correlates of mild cognitive impairment and dementia in the study population	Neuroimaging studies, ultrasound examination of extracranial carotid arteries, and ankle-brachial index determinations will be used to assess the presence of large vessel aterosclerosis and cerebral small vessel disease in the study population	One year
To assess cognitive decline in the follow-up	Enrolled individuals will be prospectively followed every year for up to five years, and will be re-assessed to determine the progression of cognitive impairment and its relationship with markers of aterosclerosis and cerebral small vessel disease	five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess cutoffs of the Montreal Cognitive Assessment useful to differentiate normal cognitivion from mild cognitive impairment, and mild cognitive impairment to dementia in the study population	The MoCA was mainly designed to separate normal individuals to those with MCI. However, a major limitation of the MoCA is its lack of accuracy for identifying persons with dementia. Therefore, the use of more complex field instruments (yet, feasible to apply in individuals living in rural settings) is needed to determine the burden of dementia and its cerebrovascular correlates in rural communities. In this regard, the Clinical Dementia Rating Scale (CDRS) is a useful tool to assess people living in these settings for establishing the burden and severity of dementia as well as to further assess clinical and neuroimaging correlates of this condition.	five years

Collaborators and Investigators

• Sponsor: Universidad de Especialidades Espiritu Santo

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Dementia; Cognitive performance; Vascular diseases; Rural Ecuador; Atahualpa; El Tambo; Prosperidad; Three villages study
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Cognition Disorders; Dementia; Cognitive Dysfunction; Atherosclerosis; Cerebral Small Vessel Diseases
• Other Study ID Numbers: 201901UEES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Dta will be available after reasonable request from an investigator for a similar study
• IPD Sharing Time Frame: June 2020
• IPD Sharing Access Criteria: email to the principal investigator
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No