Study on the Health Economic Burden of Alzheimer's Disease in China

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: There was no intervention as this was an observational study.

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 9510

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100053
    • Recruiting
    • Xuanwu Hospital, Capital Medical University
    • Contact: Yi Tang, M.D., Ph.D.; Phone Number: 00861083199456; Email: tangyixw@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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)

Description

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

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
amnestic mild cognitive impairment(aMCI）; aMCI diagnostic criteria of National Institute of Aging and National Association of Alzheimer's Disease (NIA-AA).; The ClinicalDementiaRating scale (CDR) is 0.5.; Mini-MentalStateExamination (MMSE): MMSE≥17 for those with 0 years of education, ≥20 for those with less than 7 years, and ≥24 for those with more than 7 years.; Memory impairment is prominent, and it may also be accompanied by functional impairment of other cognitive domains.; The onset is insidious and the progress is slow.; Not up to the level of dementia	Other: There was no intervention as this was an observational study.; There was no intervention as this was an observational study.
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.	Other: There was no intervention as this was an observational study.; There was no intervention as this was an observational study.
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.	Other: There was no intervention as this was an observational study.; There was no intervention as this was an observational study.
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.	Other: There was no intervention as this was an observational study.; There was no intervention as this was an observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 9, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: 2023132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No