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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| amnestic mild cognitive impairment(aMCI） |
|
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| mild AD | Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the mild AD group with a CDR score of 1. |
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| severe AD | Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the severe AD group with a score of 3. |
| |
| Moderate AD | Clinical dementia rating (CDR) was used to assess and determine the degree of cognitive impairment of the patients, according to the CDR score, where the moderate group with a score of 2. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| There was no intervention as this was an observational study. | Other | There was no intervention as this was an observational study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Direct medical expenses | Direct medical expenses refer to the expenses incurred by patients and/or their families for medical and health services related to Alzheimer's disease | baseline |
| Direct non-medical expenses | 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 | baseline |
| overhead expenses | 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. | baseline |
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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. Exclusion criteria
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The study covered all 31 provincial administrative units in mainland China, divided into six regions (Central and South/ Northeast/ East/ Central and South/ Southwest and Northwest)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | 100053 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 17, 2024 | Apr 10, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |