Alzheimer DiseaseNCT05995418
Study on the Health Economic Burden of Alzheimer's Disease in China
An observational study of Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Alzheimer Disease
- How many people
- 9,510 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Yi Tang, M.D., Ph.D., 00861083199456, tangyixw@vip.163.com
About this study
Official title: 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.
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.
- Conditions
- Alzheimer Disease
- Being tested
- There was no intervention as this was an observational study.
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There was no intervention as this was an observational study.Other
There was no intervention as this was an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: There was no intervention as this was an observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9,510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995418
- Sponsor's protocol ID
- 2023132
- Status last verified
- Jun 2026
- First submitted
- 30 Jul 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang Y, Qin Q, Yang K, Yu M, Yao Y, Gong C, Guo J, Yang L, Tang Y. Alzheimer's disease burden in China (ABC) study: protocol for a nationwide multicentre cross-sectional and prospective cohort study. BMJ Open. 2026 Sep 16;16(9):e122035. doi: 10.1136/bmjopen-2026-122035.
PubMed 42749375
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alzheimer's Disease Burden in China (ABC) Study: a Nationwide Multicentre Cross-sectional and Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05995418
- Acronym / sponsor ID
- 2023132
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9,510 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| amnestic mild cognitive impairment(aMCI） | – | Other: There was no intervention as this was an observational study.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 |
| mild AD | – | Other: There was no intervention as this was an observational study.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. |
| severe AD | – | Other: There was no intervention as this was an observational study.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 | – | Other: There was no intervention as this was an observational study.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. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There was no intervention as this was an observational study.There was no intervention as this was an observational study. | Other | Moderate AD, amnestic mild cognitive impairment(aMCI）, mild AD, severe AD |
Primary outcome
Direct medical expenses
Time frame: 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
Direct non-medical expenses
Time frame: 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
overhead expenses
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Derived from this study: PubMed 42749375Wang Y, Qin Q, Yang K, Yu M, Yao Y, Gong C, Guo J, Yang L, Tang Y. Alzheimer's disease burden in China (ABC) study: protocol for a nationwide multicentre cross-sectional and prospective cohort study. BMJ Open. 2026 Sep 16;16(9):e122035. doi: 10.1136/bmjopen-2026-122035.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct medical expenses (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995418, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.