Cerebrovascular Correlates of Dementia in Community-dwelling Older Adults Living in Remote Rural Communities - The Three Villages Study. Methodology and Operational Definitions.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- To assess cerebrovascular correlates of mild cognitive impairment and dementia in the study population
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 60 years of more residing in Atahualpa, El Tambo, and Prosperidad, who signed a comprehensive informed consent form.
排除标准
- •Severely disabled individuals in whom interviews and procedures cannot be performed
结局指标
主要结局
To assess cerebrovascular correlates of mild cognitive impairment and dementia in the study population
时间窗: 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 the prevalence and severity of dementia in the study population
时间窗: One year
The Clinical Dementia Rating Scale will be applied to all participants
To assess cognitive decline in the follow-up
时间窗: 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
次要结局
- 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(five years)
研究者
Oscar H. Del Brutto
Researcher
Universidad de Especialidades Espiritu Santo
