跳至主要内容
临床试验/NCT05995418
NCT05995418招募中不适用

The Alzheimer's Disease Burden in China (ABC) Study: a Nationwide Multicentre Cross-sectional and Prospective Cohort Study

Xuanwu Hospital, Beijing2 个研究点 分布在 1 个国家目标入组 9,510 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
9,510
试验地点
2
主要终点
Direct medical expenses

研究概览

简要总结

Alzheimer's disease (AD) presents a significant socio-economic challenge globally, with China experiencing a notable rise in its prevalence. This study addresses critical gaps in understanding AD's economic burden and quality of life (QoL) impacts on patients and caregivers in Mainland China.

详细描述

Methods: Employing a nationwide multistage clustered sampling design. The clusters were hospitals (from 31 provinces across China), which were stratified by provincial the Alzheimer's Disease population size (based on the China Alzheimer's Disease Report 2024 and the China Statistical Yearbook 2025). Within selected hospitals, sequential samples of patients dignosed with AD and aMCI were drawn The survey, incorporating validated scales and structured interviews, will assess economic burdens, QoL, and caregiver burdens. Statistical analyses, including multiple linear regression models and random forest techniques, will examine factors associated with economic burdens and QoL.

Discussion: This research, spanning all provinces of mainland China, promises to be a timely analysis of AD's economic burden. Beyond quantifying direct and indirect costs, it integrates validated scales to understand patients' and caregivers' emotional and social dimensions. Insights gleaned will inform targeted interventions, caregiver support strategies, and evidence-based policy reforms, thereby enhancing AD care quality and resource allocation efficiency in Chinese healthcare settings. Ethical considerations and future research avenues are also outlined, emphasizing a comprehensive and forward-looking approach.

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
40 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed according to the National Institute on Aging-Alzheimer's 1.Association (NIA-AA) criteria for aMCI and AD.
  • 2.Clinical Dementia Rating (CDR) score greater than or equal to 0.5 3.Have good visual, auditory, and language functions, or can complete neuropsychological assessments after correction.
  • 4.Participants or their legal representatives sign informed consent.

排除标准

  • History of stroke with neurological focal signs and imaging findings consistent with cerebral small vessel disease (Modified Fazekas score ≥2).
  • Presence of mental or neurological developmental delay.
  • Presence of other known conditions that may cause cognitive impairment.
  • Diagnosis of a disease that prevents completion of cognitive assessments.
  • Refusal to sign informed consent at baseline.

结局指标

主要结局

Direct medical expenses

时间窗: baseline

Direct medical expenses refer to the expenses incurred by patients and/or their families for medical and health services related to Alzheimer's disease

overhead expenses

时间窗: baseline

Indirect costs include the economic loss caused by patients' inability to work, the decrease in the income of informal caregivers, the treatment expenses of caregivers' psychological diseases and the medical expenses incurred by patients with Alzheimer's disease or caregivers due to accidental injuries.

Direct non-medical expenses

时间窗: baseline

The direct non-medical costs of Alzheimer's disease include care costs, home facilities and repair costs, health care products costs and related expenses incurred during medical treatment. The cost of care includes the salary of caregivers, the expenses of external caregivers, and the travel expenses of caregivers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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