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

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ClinicalTrials.gov Identifier: NCT04123171
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Oscar H. Del Brutto, Universidad de Especialidades Espiritu Santo

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.

Condition or disease Intervention/treatment
Dementia Cardiovascular Risk Factor Atherosclerosis Cerebral Small Vessel Diseases Cognitive Decline 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Cerebrovascular Correlates of Dementia in Community-dwelling Older Adults Living in Remote Rural Communities - The Three Villages Study. Methodology and Operational Definitions.
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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




Primary Outcome Measures :
  1. To assess the prevalence and severity of dementia in the study population [ Time Frame: One year ]
    The Clinical Dementia Rating Scale will be applied to all participants

  2. To assess cerebrovascular correlates of mild cognitive impairment and dementia in the study population [ Time Frame: One year ]
    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

  3. To assess cognitive decline in the follow-up [ Time Frame: five years ]
    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


Secondary Outcome Measures :
  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 [ Time Frame: five years ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes 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.
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123171


Locations
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Ecuador
Universidad de Especialidades Espiritu Santo Recruiting
Samborondon, Guayas, Ecuador, 092301
Contact: Oscar H Del Brutto, MD    593-997476984    odelbrutto@uees.edu.ec   
Contact: Bettsy Y Recalde, MD    59342907332    bettsyr@hotmail.es   
Community Center Recruiting
Atahualpa, Santa Elena, Ecuador
Contact: Bettsy Y Recalde, MD    59342907332    bettsyr@hotmail.com   
Sponsors and Collaborators
Universidad de Especialidades Espiritu Santo

Publications of Results:
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Responsible Party: Oscar H. Del Brutto, Researcher, Universidad de Especialidades Espiritu Santo
ClinicalTrials.gov Identifier: NCT04123171     History of Changes
Other Study ID Numbers: 201901UEES
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Dta will be available after reasonable request from an investigator for a similar study
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: June 2020
Access Criteria: email to the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oscar H. Del Brutto, Universidad de Especialidades Espiritu Santo:
Dementia
Cognitive performance
Vascular diseases
Rural Ecuador
Atahualpa
El Tambo
Prosperidad
Three villages study
Additional relevant MeSH terms:
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Dementia
Cerebral Small Vessel Diseases
Atherosclerosis
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cognition Disorders
Cerebrovascular Disorders