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

9. oktober 2019 opdateret af: Oscar H. Del Brutto, Universidad de Especialidades Espiritu Santo

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Ecuador
    • Guayas
      • Samborondon, Guayas, Ecuador, 092301
        • Rekruttering
        • Universidad de Especialidades Espiritu Santo
        • Kontakt:
        • Kontakt:
    • Santa Elena
      • Atahualpa, Santa Elena, Ecuador
        • Rekruttering
        • Community center
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

-

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk test: Neuroimaging studies
Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form
Andre navne:
  • Ultrasound examinations
  • Ankle-brachial index determinations

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To assess the prevalence and severity of dementia in the study population
Tidsramme: One year
The Clinical Dementia Rating Scale will be applied to all participants
One year
To assess cerebrovascular correlates of mild cognitive impairment and dementia in the study population
Tidsramme: 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
One year
To assess cognitive decline in the follow-up
Tidsramme: 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
five years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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.
five years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universidad de Especialidades Espiritu Santo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2019

Primær færdiggørelse (Forventet)

30. juni 2020

Studieafslutning (Forventet)

30. juni 2024

Datoer for studieregistrering

Først indsendt

9. oktober 2019

Først indsendt, der opfyldte QC-kriterier

9. oktober 2019

Først opslået (Faktiske)

10. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 201901UEES

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

Dta will be available after reasonable request from an investigator for a similar study

IPD-delingstidsramme

June 2020

IPD-delingsadgangskriterier

email to the principal investigator

IPD-deling Understøttende informationstype

  • Studieprotokol
  • Statistisk analyseplan (SAP)
  • Formular til informeret samtykke (ICF)
  • Klinisk undersøgelsesrapport (CSR)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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