Research Direction, Centro Nacional de Biopreparados, Bejucal, Cuba.
Clinical trials, Research Direction, Centro Nacional de Biopreparados, Bejucal, Cuba.
BMJ Open. 2022 Nov 2;12(11):e052704. doi: 10.1136/bmjopen-2021-052704.
According to the World Alzheimer's Report 2019, around 50 million people suffer from dementia, worldwide. Observational analysis revealed the existence of particular factors associated with the onset and progression of Alzheimer's disease (AD). There are no international homogeneous principles for the early detection and evaluation of memory impairment and possible AD. This work aimed at (1) determining the prevalence of possible AD in the elderly residing in urban and rural regions in Cuba and (2) identifying the main factors that could significantly influence on its occurrence.
The study includes four neuropsychological tests (Clock Drawing Test, Mini-Mental Status Examination, Short Portable Mental Status Questionnaire, Cognitive and Non-Cognitive Alzheimer's Disease Assessment Scale) and two scales (Clinical Dementia Rating and Global Deterioration Scale). Moreover, the protocol includes a survey with demographic and socioeconomic information, educational level, occupation, health, neuropsychological status of subjects, familial pathological history, comorbidities and lifestyles. The study will comprise a total of 1092 subjects aged ≥60, of both genders, and from every ethnic group settled in rural and urban areas.
prevalence of possible AD.
correlation among risk and protective factors and AD, and comparison of the performance of neuropsychological tests and scales.
This research met the ethical codes of the Declaration of Helsinki. The Scientific Research Council of the Promoting Research Institute and the Ethics Committee of the Health Authorities approved the protocol. The proper written informed consent is also incorporated. The results of the survey will be published in scientific papers and shared with the Health Authorities of each municipality.
根据 2019 年世界阿尔茨海默病报告,全球约有 5000 万人患有痴呆症。观察性分析揭示了与阿尔茨海默病(AD)发病和进展相关的特定因素的存在。目前,尚无国际统一的原则用于早期发现和评估记忆障碍和可能的 AD。本研究旨在:(1)确定居住在古巴城乡的老年人中可能患有 AD 的患病率;(2)确定可能对其发生有显著影响的主要因素。
该研究包括四项神经心理学测试(画钟测试、简易精神状态检查、简短便携精神状态问卷、认知和非认知阿尔茨海默病评估量表)和两项量表(临床痴呆评分和总体衰退量表)。此外,该方案还包括一项包含人口统计学和社会经济信息、教育程度、职业、健康、受试者的神经心理学状况、家族病史、合并症和生活方式的调查。该研究将共纳入 1092 名年龄≥60 岁、性别不限、来自农村和城市地区的各个种族的受试者。
可能患有 AD 的患病率。
风险和保护因素与 AD 之间的相关性,以及神经心理学测试和量表的性能比较。
本研究符合《赫尔辛基宣言》的伦理准则。促进研究所的科学研究委员会和卫生当局的伦理委员会批准了该方案。还纳入了适当的书面知情同意书。该调查的结果将发表在科学论文中,并与每个直辖市的卫生当局共享。