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

NCT04123171 | Unknown DMC

• 1 other identifier: 201901UEES
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Dementia; Cognitive performance; Vascular diseases; Rural Ecuador; Atahualpa; El Tambo; Prosperidad; Three villages study

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

  five years

Study Arms (1)

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

Interventions

Neuroimaging studies DIAGNOSTIC_TEST

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

Also known as: Ultrasound examinations, Ankle-brachial index determinations

The Three Villages Cohort

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (2)

Universidad de Especialidades Espiritu Santo

Samborondón, Guayas, 092301, Ecuador

RECRUITING

Community Center

Atahualpa, Santa Elena, Ecuador

RECRUITING

Related Publications (5)

• 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.

  PMID: 23506643 RESULT

• 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.

  PMID: 31446542 RESULT

• 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.

  PMID: 28548298 RESULT

• 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.

  PMID: 26833914 RESULT

• 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.

  PMID: 29088979 RESULT

MeSH Terms

Conditions

Dementia; Atherosclerosis; Cerebral Small Vessel Diseases; Cognitive Dysfunction; Vascular Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 10, 2019
• Study Start: June 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2024
• Last Updated: October 10, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 2020
• Access Criteria: email to the principal investigator

Locations

EC (2)