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China Cognition and Aging Study

China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03653156
Acronym
COAST
Enrollment
100000
Registered
2018-08-31
Start date
2000-01-01
Completion date
2038-01-01
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Mild Cognitive Impairment(MCI), Non-Alzheimer Degenerative Dementia, Normal Control, Vascular Dementia (VaD)

Brief summary

The aim of this study is to establish and perfect the China Cognition and Aging Study (China COAST) cohort, to clarify the epidemiology, influencing factors, genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive national database of cognitive disorders, improve the clinical diagnosis and treatment level of cognitive disorders, and formulate prevention and treatment strategies for dementia. The primary aims of China COAST are as follows: 1. To use the prospective cohort to establish a large database research platform, so as to provide comprehensive epidemiological data, clinical and neuropsychological evaluation data, biological samples, and laboratory tests and imaging data. 2. To update the prevalence and incidence rate of dementia and its subtypes every 2-3 years, and clarify the conversion pattern from normal elderly to MCI and from MCI to dementia. 3. To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia). 4. To discover new pathogenic genes and susceptible genes of dementia and its major subtypes (AD and VaD), as well as new mutation sites of known pathogenic genes. To study the genetic variation, mutation and polymorphism of PSEN1, PSEN2, APP and APOE genes in dementia patients, and to understand their distribution and roles in the pathogenesis. 5. To study the biomarkers (body fluid, genetics, imaging) with diagnostic value of MCI, AD (sporadic and familial) and VaD, to define their cut-off values, and to establish prediction models. 6. To study the diagnostic criteria of cognitive normal, MCI, dementia and their subtypes (clinical and molecular subtypes) in the cohort, and to make psychological assessment scales with high sensitivity and specificity, and in line with the characteristics of Chinese people. 7. To find potentially modifiable risk factors for dementia and to study the prevention and intervention effect of non-pharmacological treatment on APOE ε4 carriers, MCI and AD or other dementia patients,which included improvements in education, nutrition, health care, and lifestyle changes. This needs a long time follow-up. 8. To explore the relationship between dementia as well as its major subtype AD and cerebral and systemetic circulatory disorders (for example, mixed dmentia), as well as potential therapeutic strategies. 9. To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia. 10. To investigate the level of stigma and discrimination and its influencing factors in patients with Alzheimer's disease and their caregivers.

Detailed description

This study involved participants including Mild cognitive impairment (MCI) and its subtypes、Sporadic Alzheimer's disease (SAD)、 Familial Alzheimer's disease (FAD)、Vascular dementia (VaD)、Normal control in community population and hospital population. Research contents are as follow: 1. Through the collection of basic demographic information and clinical data from the multi-center cohort, we will calculate the prevalence and incidence rate of AD, VaD, other dementia (mixed dementia, FTD, DLB, PDD, alcohol dementia, hydrocephalus dementia, post-traumatic dementia, etc.), and update the numbers every 1-2 years. 2. To clarify the conversion pattern from normal elderly to MCI and from MCI to dementia. Through the collection and analysis of current medical history, past history, family history, living habits, drug use, physical examination and other information, we will explore the protective and risk factors of dementia and its main subtypes (AD, VaD, Other dementia), including age, gender, education level, rural/urban, marital status, parental dementia history, dietary habbit, blood pressure, drinking, smoking, diabetes, hyperlipidemia, cerebrovascular disease, heart disease, depression, hearing impairment, exercise habits (Tai chi, etc.), dementia specialist influence on patients, occupation, BMI, lifestyle changes, air pollution, head injury , social contact, low-income, and other unknown protective or risk factors. To investigate the role of ApoE gene, especially ApoEε4 in the disease onset and development, and to explore the non-pharmacological interventions For the study purpose we do follow-up every 2or 3 years. 3. By using exome sequencing, GWAS, WGS and other methods, we will search for new mutations of known pathogenic genes (APP, PSEN1, PSEN2) of AD in China, find new pathogenic genes and susceptible genes of dementia and its main subtypes (AD and VaD), and understand their distribution. We will explore the independent and combined effect of susceptibility gene variation on the risk of illness in Chinese AD population, and to obtain the key mutation sites that have a clear relationship with the incidence of AD. We will do regular follow up visits for the FAD members with new mutations of pathogenic genes, and clarify the important role of new mutations of pathogenic genes during the onset and progression of AD. 4. We will collect the biofluids (blood, cerebrospinal fluid, urine, etc.) and 18F-FDG / 11C-PIB PET/MR multimodal imaging data from people with normal cognition, MCI, AD (sporadic and familial) and VaD, and conduct regular follow up. Discover and verify the SAD related susceptible gene and FAD related pathogenic gene mutation. Through analyzing the imaging data (such as MRI brain regional volume, 18F-FDG PET and cortical Aβ load), cerebrospinal fluid and plasma markers (such as Aβ, T-tau and P-tau) and clinical features (such as psychiatric symptoms and age of onset), we will develop gene chip with high sensitivity and high specificity for early screening of dementia; develop diagnostic kits for biofluid markers (blood and cerebrospinal fluid); determine imaging cut-off values at all stages of dementia in Chinese people. We will do correlation analysis to establish early diagnosis and risk prediction model for dementia, and verify the newly developed instruments that can detect the peripheral markers of dementia patients and predict the disease progression in national large sample. 5. Through the unified and standardized neuropsychological scales, including MMSE, MoCA, CDR, NPI, ADL, etc, we will conduct investigation to subjects in baseline and follow-up period, and analyze the changes of cognitive function, ability of daily life and mental behavior symptoms in different cognitive disorders. According to the social, cultural and material changes in China in recent years, we will develop psychological assessment scales with high sensitivity and specificity, and in line with the characteristics of Chinese people. Meanwhile, on the basis of the international diagnostic standards of various subtypes of dementia, combined with the etiology, clinical manifestations, scale classification, imaging characteristics, biofluid examination, etc., we will study the novel typing method and diagnostic standards of cognitive normal, MCI, dementia and its subtypes (clinical and molecular subtypes) in Chinese population. 6. Through designing randomized controlled trials, we will study the systematic and effective NPT intervention program, including lifestyle (diet and sleep habits, smoking, drinking and social networking), health products, exercise habits, cognitive training, risk factor control, etc. We will explore the quantitative and objective evaluation criteria of NPT in AD and dementia, clarify its prevention and control efficacy on APOE ε4 carriers, MCI and dementia patients, and potential neurobiological mechanism. At the same time, we will carry out dementia related education in the community, improve the public knowledge, attention and awareness of dementia, so that patients can get early detection, early diagnosis and early intervention. 7. To explore the relationship between dementia as well as its major subtype AD and cerebral circulatory disorders (cerebral ischemic and hemorrhage diseases, cerebral arteriosclerosis and stenosis, cerebral venous diseases, etc.), especially clarify the relationship between chronic cerebral ischemia and AD, as well as its effect on AD onset, and whether or not it's risk factor for AD. Whether the therapeutic strategies for cerebral circulatory disorders should be included in the treatment of AD.

Interventions

None listed

Sponsors

Capital Medical University
Lead SponsorOTHER
Beijing Tiantan Hospital
CollaboratorOTHER
Beijing Chao Yang Hospital
CollaboratorOTHER
Fu Xing Hospital, Capital Medical University
CollaboratorOTHER
Peking Union Medical College Hospital
CollaboratorOTHER
Peking University First Hospital
CollaboratorOTHER
Peking University Third Hospital
CollaboratorOTHER
Chinese PLA General Hospital
CollaboratorOTHER
China-Japan Friendship Hospital
CollaboratorOTHER
Beijing Geriatric Hospital
CollaboratorOTHER
The First Affiliated Hospital of Dalian Medical University
CollaboratorOTHER
Fujian Medical University Union Hospital
CollaboratorOTHER
Guangzhou Psychiatric Hospital
CollaboratorOTHER_GOV
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
First Affiliated Hospital of Guangxi Medical University
CollaboratorOTHER
The Affiliated Hospital Of Guizhou Medical University
CollaboratorOTHER
Handan Central Hospital
CollaboratorOTHER
Hebei General Hospital
CollaboratorOTHER
First Hospital of Shijiazhuang City
CollaboratorOTHER
Tangshan Worker's Hospital
CollaboratorOTHER
Hunan Provincial People's Hospital
CollaboratorOTHER
Kaifeng Central Hospital
CollaboratorOTHER
People's Hospital of Zhengzhou University
CollaboratorOTHER
Zhongnan Hospital
CollaboratorOTHER
First Affiliated Hospital of Harbin Medical University
CollaboratorOTHER
Tongji Hospital
CollaboratorOTHER
People's Hospital Affiliated Hubei Medical University
CollaboratorUNKNOWN
The Third Xiangya Hospital of Central South University
CollaboratorOTHER
Xiangya Hospital of Central South University
CollaboratorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
China-Japan Union Hospital, Jilin University
CollaboratorOTHER
Subei People's Hospital of Jiangsu
CollaboratorUNKNOWN
Nantong University Affiliated Hospital
CollaboratorUNKNOWN
Mineral General Hospital, Xuzhou
CollaboratorUNKNOWN
Jiangxi Provincial People's Hopital
CollaboratorOTHER
Anshan Central Hospital
CollaboratorOTHER
Affiliated Zhongshan Hospital of Dalian University
CollaboratorOTHER
First Hospital of China Medical University
CollaboratorOTHER
Baotou Central Hospital
CollaboratorOTHER
General Hospital of Ningxia Medical University
CollaboratorOTHER
The People's Hospital of Ningxia
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
The 960th Hospital of PLA
CollaboratorUNKNOWN
Qilu Hospital of Shandong University
CollaboratorOTHER
Qilu Hospital of Shandong University (Qingdao)
CollaboratorOTHER
Shandong Provincial Hospital
CollaboratorOTHER_GOV
Qingdao Municipal Hospital
CollaboratorOTHER
The First Affiliated Hospital of Shanxi Medical University
CollaboratorOTHER
Tang-Du Hospital
CollaboratorOTHER
First Affiliated Hospital Xi'an Jiaotong University
CollaboratorOTHER
Ruijin Hospital
CollaboratorOTHER
RenJi Hospital
CollaboratorOTHER
Shanghai Changzheng Hospital
CollaboratorOTHER
Affiliated Hospital of North Sichuan Medical College
CollaboratorOTHER
Tianjin Huanhu Hospital
CollaboratorOTHER
Tianjin Medical University General Hospital
CollaboratorOTHER
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
CollaboratorUNKNOWN
Ningbo Medical Center Lihuili Hospital
CollaboratorOTHER_GOV
First Affiliated Hospital of Wenzhou Medical University
CollaboratorOTHER
First Affiliated Hospital of Zhejiang University
CollaboratorOTHER
Shao Yifu Hospital of Zhejiang Medical University
CollaboratorUNKNOWN
Zhejiang Provincial People's Hospital
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
CollaboratorOTHER
The Second Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
The First Affiliated Hospital of Anhui Medical University
CollaboratorOTHER
People's Hospital of Chongqing
CollaboratorOTHER
Dongfang Hospital Beijing University of Chinese Medicine
CollaboratorOTHER
Zigong No.1 Peoples Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Community population: age ≥ 55 years, male or female, with consent to participant the study. Hospital population: subjects are all over 18 years old. Through clinical evaluation, neuropsychological test, imaging examination, blood and cerebrospinal fluid examination, etc, we will comprehensively evaluate the cognitive function and various test measures. (1) MCI and its subtypes Inclusion criteria: 1. Diagnosis according to 2004 Peterson's MCI criteria. 2. CDR = 0.5. 3. Memory loss is prominent, and may also be with other cognitive domain dysfunction. 4. Insidious onset, slow progress. 5. Not reaching the level of dementia.

Exclusion criteria

1. With history of stroke and a neurological focal sign, the imaging findings are consistent with cerebral small vessal disease (Fazekas score ≥ 2 points). 2. Other neurological diseases that can cause brain dysfunction (such as depression, brain tumor, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal intracranial pressure hydrocephalus, etc.). 3. Other systemic diseases that can cause cognitive impairment (such as liver, renal and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.). 4. Mental and neurodevelopmental retardation. 5. Contraindications to MRI. 6. Suffering from a disease that cannot be combined with cognitive examination. 7. Refuse to draw blood. 8. Refuse to sign the informed consent at baseline (2) Sporadic Alzheimer's disease (SAD) Inclusion criteria: 1. Dementia is diagnosed according to the criteria described by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R). The diagnosis of AD is made using the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) or National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. 2. Subjects and their informed persons can complete relevant and follow- up examinations. 3. Subjects or their authorized legal guardians sign the informed consent.

Design outcomes

Primary

MeasureTime frameDescription
The prevalence of MCI and AD measured using a population-based cross-sectional survey with a multistage cluster sampling designan average of 2 years
The conversion rate of normal to MCI to AD in Chinesean average of 2 years
The biomarkers for normal (pre-MCI), MCI and AD diagnosisan average of 2 yearsHumoral biomarkers are included Aβ42, Aβ40, phosphated tau and total tau in plasma, cerebrospinal fluid, saliva, and urine. Imaging biomarkers are included cerebral volume, glucose metabolism, amyloid and tau deposition of whole brain or hippocampus.
The risk factors (genetic and environmental factors) for MCI, AD and VCI at genomic and expression levelsan average of 2 yearsDiscover risk factors including genetic susceptibility loci (APOE genes and other risk genes) using gene sequencing, cardiovascular risk factors (blood glucose, cholesterol, homocysteine) using laboratory tests, and unhealthy lifestyle using questionnaire.
The effective non-pharmacologic treatment(NPT) interventionan average of 2 yearsThe effective non-pharmacologic treatment(NPT) intervention- including lifestyle(diet and sleep habits, smoking, drinking and social networking), health products, exercise habits, cognitive training, risk factor control- on APOE ε4 carriers, MCI and dementia patients using questionnaire.

Countries

China

Contacts

CONTACTJianping Jia, Doctor
jiajp@vip.126.com
STUDY_CHAIRJianping Jia, Doctor

Xuanwu Hospital of Capital Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026