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
|Condition or disease||Intervention/treatment|
|Dementia Cardiovascular Risk Factor Atherosclerosis Cerebral Small Vessel Diseases Cognitive Decline||Diagnostic Test: Neuroimaging studies|
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 [Patient Registry]|
|Estimated Enrollment :||600 participants|
|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|
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
- 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
- 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
- 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
- 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.
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
|Universidad de Especialidades Espiritu Santo||Recruiting|
|Samborondon, Guayas, Ecuador, 092301|
|Contact: Oscar H Del Brutto, MD 593-997476984 firstname.lastname@example.org|
|Contact: Bettsy Y Recalde, MD 59342907332 email@example.com|
|Atahualpa, Santa Elena, Ecuador|
|Contact: Bettsy Y Recalde, MD 59342907332 firstname.lastname@example.org|