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

Dementia Clinical Trial

Official title:

Cerebrovascular Correlates of Dementia in Community-dwelling Older Adults Living in Remote Rural Communities - The Three Villages Study. Methodology and Operational Definitions.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04123171
• Other study ID #: 201901UEES
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2019
• Source: Universidad de Especialidades Espiritu Santo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2020
• Gender: All
• Age group: 60 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Risk Factor
• Cerebral Small Vessel Diseases
• Cognitive Decline
• Cognitive Dysfunction
• Dementia

Intervention

Diagnostic Test:
• Neuroimaging studies
Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form

Locations

Country	Name	City	State
Ecuador	Community Center	Atahualpa	Santa Elena
Ecuador	Universidad de Especialidades Espiritu Santo	Samborondon	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Especialidades Espiritu Santo

Country where clinical trial is conducted

Ecuador, 

References & Publications (5)

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. — View Citation

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 — View Citation

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. 2019 Aug 24. do — View Citation

Del Brutto OH, Peñaherrera E, Ochoa E, Santamaría 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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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	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.	five years