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

Universidad de Especialidades Espiritu Santo

Status: Enrolling

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

Treatments: Diagnostic Test: Neuroimaging studies

Study type: Observational

Funder types: Other

Identifiers

NCT04123171

201901UEES

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

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

Trial design

600 participants in 1 patient group

The Three Villages Cohort

Description:

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.

Treatment:

Diagnostic Test: Neuroimaging studies