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RecruitingNCT05995418Updated Jun 5, 2026

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

An observational study in Alzheimer Disease, sponsored by Xuanwu Hospital, Beijing. Recruiting at 1 site in China. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Xuanwu Hospital, Beijing · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
9,510
Ages
40 Years to 100 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Alzheimer Disease

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03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 9,510 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 100 Years
Sexes eligible
All
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)

Eligibility criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
9,510 participants (estimated)
Patient registry
No

Groups and cohorts

  • amnestic mild cognitive impairment(aMCI)

    1. aMCI diagnostic criteria of National Institute of Aging and National Association of Alzheimer's Disease (NIA-AA). 2. The ClinicalDementiaRating scale (CDR) is 0.5. 3. 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. 4. Memory impairment is prominent, and it may also be accompanied by functional impairment of other cognitive domains. 5. The onset is insidious and the progress is slow. 6. Not up to the level of dementia

    Other: 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.

  • 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.

  • 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.

Interventions

  • OtherThere was no intervention as this was an observational study.

    There was no intervention as this was an observational study.

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What researchers measure

Primary outcomes

  1. 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

    Time frame: baseline

  2. 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

    Time frame: baseline

  3. 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.

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • Xuanwu Hospital, Capital Medical University
    Beijing, 100053, China
    Recruiting
08

References and documents

Study documents

  • Study protocol · Jul 17, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05995418
Lead sponsor
Xuanwu Hospital, Beijing
Responsible party
Sponsor
First posted
Aug 16, 2023
Start date
Jul 1, 2023
Primary completion
Jun 30, 2026 (estimated)
Completion
Jan 1, 2027 (estimated)
Last update
Jun 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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