NCT04123171

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Universidad de Especialidades Espiritu Santo · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: —

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Neuroimaging studies	Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-06-30
• Completion: 2024-06-30
• First posted: 2019-10-10
• Last updated: 2019-10-10

Locations

2 sites across 1 country: Ecuador