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

NCT ID: NCT05995418

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 9510 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-08-31

Brief Summary

This study is a multi-center and cross-sectional study. Using standardized case report forms, we randomly selected suitable patients from the cognitive centers of provincial administrative units in Chinese mainland to conduct a questionnaire survey, so as to obtain relevant information about their economic burden.

Detailed Description

Under the policy background of building a national cognitive center, this study collected and evaluated the socio-demographic characteristics, geographical location, regional socio-economic development level, family support, medical resources, related behaviors, nursing environment, patients' health behaviors, current medical history, past history, drug use, family history and clinical diagnosis of Alzheimer's patients in inland provinces and cities of China, and made statistics on the related information of patients' health economics. To form a comprehensive assessment of the health economic burden of Alzheimer's disease in China, the primary objectives of the study are as follows:

1. Comprehensively assess the health economic burden of Alzheimer's disease, including medical and non-medical costs.

2. Explore the economic burden of Alzheimer's disease in different stages, including mild cognitive impairment stage, mild to moderate Alzheimer's disease stage and severe Alzheimer's disease stage.

3. To explore the health economic burden of the comorbidity of Alzheimer's disease and other chronic diseases.

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

There was no intervention as this was an observational study.

Intervention Type: OTHER

There was no intervention as this was an observational study.

mild to 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 mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.

There was no intervention as this was an observational study.

Intervention Type: 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 mild AD group with a CDR score of 1, and the moderate to severe AD group with a score of 2 to 3.

There was no intervention as this was an observational study.

Intervention Type: OTHER

There was no intervention as this was an observational study.

Interventions

There was no intervention as this was an observational study.

There was no intervention as this was an observational study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Criteria for selection of centers The study center sample relied on the 192 cognitive centers selected for the 2022 National Health and Health Commission Capacity Building and Continuing Education for Cognitive Impairment Disease Specialty Capacity Building Program.

The study covered all 31 provincial administrative units in mainland China, divided according to east, center, and west:

East: Hebei, Beijing, Tianjin, Shandong, Jiangsu, Shanghai, Zhejiang, Fujian, Guangdong, Hainan, Heilongjiang, Jilin, and Liaoning; Central: Henan, Hubei, Hunan, Anhui, Jiangxi, Shanxi; West: Chongqing, Sichuan, Yunnan, Guizhou, Tibet, Shaanxi, Gansu, Qinghai, Xinjiang, Ningxia, Inner Mongolia, Guangxi.

1. Compliance with Peterson's aMCI diagnostic criteria National Institute on Aging and Alzheimer's Disease Association (NIA-AA) aMCI diagnostic criteria in 2004 [7].

2. Clinical Dementia Rating (CDR) of 0.5.

3. Mini-Mental State Examination (MMSE): ≥17 points on MMSE for those with 0 years of education, ≥20 points for those with less than 7 years, and ≥24 points for those with greater than or equal to 7 years.

4. Memory loss is prominent and may also be accompanied by impairment of other cognitive domains.

5. Insidious onset and slow progression.

1. Meets the core clinical criteria for probable AD dementia in the 2011 NIA-AA Revised Diagnostic Criteria for AD. [7]

2. Can be categorized as having mild, moderate, or severe Alzheimer's disease.

1. Mild: progressive cognitive impairment affecting multiple domains and psychobehavioral deficits; significant impact on daily life, primarily impairing instrumental activities, no longer fully independent, occasionally requiring assistance; or a CDR score of 1.0

2. Moderate: progressive cognitive impairment and psychobehavioral changes; extensive impact on daily life, partial impairment of basic functioning, inability to live independently, frequent need for assistance; or CDR 2.0 score

3. Severe: progressive cognitive impairment and psychobehavioral changes, may not be able to conduct clinical interviews; severe impact on daily life, impairment of basic activities including self-care, total dependence on help; or CDR 3.0 points

3. CDR greater than 0.5 points.

4. MMSE: <17 points for those with 0 years of education, <20 points for those with less than 7 years, and <24 points for those with greater than or equal to 7 years.

5. Subject has good audiovisual and speech functions or can complete a neuropsychological examination with correction.

6. The subject and the informant can complete relevant examinations and follow-up visits.

1. Age not less than 60 years

2. Normal or corrected vision and hearing

3. able to provide informed consent signed by him/herself or a legal guardian

4. Newly diagnosed or previously diagnosed with a co-morbid condition other than aMCI or Alzheimer's disease.

Exclusion Criteria

1. Those with a history of stroke with focal neurologic signs and an imaging presentation consistent with cerebral small vessel disease manifestations (Fazekas score ≥ 2).

2. Presence of mental and neurodevelopmental delays.

3. Presence of other conditions known to cause cognitive impairment.

4. Presence of a disease that prevents cooperation in completing the cognitive examination.

1. Poor compliance or mental and neurodevelopmental delays.

2. Illness that prevents the completion of the cognitive examination.

3. Refusal to sign an informed consent form at baseline.

4. Severe circulatory, respiratory, urinary, gastrointestinal, hematopoietic diseases (e.g., unstable angina, uncontrolled asthma, active gastric bleeding, etc.) and cancer.

5. No reliably informed person.

6. Patient has a history of alcohol or drug abuse.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital, Capital Medical University

Beijing, , China

Countries

China

Other Identifiers

2023132

Identifier Type: -

Identifier Source: org_study_id