NCT03653156Recruiting
China Cognition and Aging Study
China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100000 (estimated)
- First submitted
- 23 Aug 2018
- Start date
- 1 Jan 2000
- Primary completion date
- 1 Jan 2038
- Lead sponsor
- Capital Medical University
- Diseases
- Alzheimer disease
- NCT number
- NCT03653156
What you commit to
- Study type: Observational
- Planned participants: 100000
- From 1 Jan 2000 to the primary completion date, 1 Jan 2038
- 65 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- With history of stroke and a neurological focal sign, the imaging findings are consistent with cerebral small vessal disease (Fazekas score ≥ 2 points).
- 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.).
- 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.).
- Suffering from a disease that cannot be combined with cognitive examination.
- Refuse to sign the informed consent at baseline
- (2) Sporadic Alzheimer's disease (SAD)
- With a family history of dementia.
- 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.).
- 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.).
- Suffering from a disease that cannot be combined with cognitive examination.
- Refuse to sign the informed consent at baseline
- (3) Familial Alzheimer's disease (FAD)
- Dementia caused by other factors such as depression, other psychiatric illnesses, thyroid dysfunction, encephalitis, multiple sclerosis, brain trauma, brain tumor, syphilis, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease and other types of dementias such as vascular dementia (VaD), frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and Parkinson's disease dementia (PDD).
- Severe circulatory, respiratory, urinary, digestive, hematopoietic diseases (such as unstable angina, uncontrollable asthma, active gastric bleeding) and cancer.
- Participant has severe psychiatric illness or severe dementia that would interfere in completing initial and follow-up clinical assessments.
- With history of alcohol or drug abuse.
- Refuse to sign the informed consent at baseline.
- (4) Vascular dementia (VaD)
- 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.).
- Other systemic diseases that can cause cognitive impairment (such as liver insufficiency, renal insufficiency, thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.).
- With a history of mental illness or those with congenital mental retardation.
- Suffering from a disease that cannot be combined with a cognitive examination.
- Subjects with a history of cerebral infarction, traumatic brain injury or related manifestations in MRI.
- 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.).
- 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.).
- Suffering from a disease that cannot be combined with a cognitive examination.
Lab values
- MRI and laboratory tests do not support or rule out a diagnosis of AD.
Other
- Mental and neurodevelopmental retardation.
- Contraindications to MRI.
- Refuse to draw blood.
- Mental and neurodevelopmental retardation.
- Contraindications to MRI.
- Refuse to draw blood.
- Pregnant or lactating women.
- No reliable insiders.
- Contraindications to MRI.
- Refuse to draw blood.
- Refuse to sign informed consent.
- (5) Normal control
- Subjects with abnormal MMSE or MoCA scores.
- Mental and neurodevelopmental retardation.
- Contraindications to MRI.
- Refuse to draw blood.
- Refuse to sign the informed consent at baseline.
Who the study is looking for
- Diagnosis according to 2004 Peterson's MCI criteria.
- CDR = 0.5.
- Memory loss is prominent, and may also be with other cognitive domain dysfunction.
- Insidious onset, slow progress.
- Not reaching the level of dementia.
- 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.
- Subjects and their informed persons can complete relevant and follow- up examinations.
- Subjects or their authorized legal guardians sign the informed consent.
- Written informed consent obtained from participant or legal guardian prior to any study-related procedures.
- Members in FAD pedigree (FAD is defined as at least two first- degree relatives suffer from AD).
- Aged 18 (inclusive) or older.
- At least two persons who can provide reliable information for the study. Note: Dementia is diagnosed according to the criteria described by DSM-IV-R. The diagnosis of AD is made using NINCDS-ADRDA or NIA-AA criteria. A diagnosis of MCI is assigned according to Petersen criteria.
- Diagnosis for probable VaD according to NINDS-AIREN diagnostic criteria.
- MRI inclusion criteria:
- All patients who meet clinical inclusion criteria should accept MRI scans which include an assessment of hippocampal volume.
- multiple (≥3) supratentorial subcortical small infarcts (3-20 mm in diameter) with or without any degree of white matter lesion (WML); or moderate to severe WML (Fazekas score ≥ 2), with or without small infarction; or ≥ 1 subcortical small infarct in key regions, such as caudate nucleus, globus pallidus, or thalamus.
- no cortical and watershed infarction, hemorrhage, hydrocephalus, or WML with specific causes (such as multiple sclerosis).
- no hippocampus or entorhinal cortex atrophy (MTA score = 0 point).
- Aged 18 (inclusive) or above.
- Normal MMSE and MoCA evaluations. MMSE\>19 points for illiteracy, \>24 points for those educated less than 7 years, \>27 points for those educated equal to or more than 7 years. MoCA\>13 points for illiteracy, \>19 points for those educated less than 7 years, \>24 points for those educated equal to or more than 7 years.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (65)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changda Hospital, Anshan Coordinator of this site? Confirm its status | Anshan | China | Recruiting |
| Baotou Central Hospital Coordinator of this site? Confirm its status | Baotou | China | Recruiting |
| China-Japan friendship Hospital of Jilin university Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Beijing Geriatric Hospital Coordinator of this site? Confirm its status | Changping | China | Recruiting |
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Chaoyang | China | Recruiting |
| Beijing Chao Yang Hospital Coordinator of this site? Confirm its status | Chaoyang | China | Recruiting |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Affiliated Zhongshan Hospital of Dalian University Coordinator of this site? Confirm its status | Dalian | China | Recruiting |
| Dongfang Hospital Affiliated to Beijing University of Chinese Medicine Coordinator of this site? Confirm its status | Fengtai | China | Recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fujian | China | Recruiting |
| Guangzhou Psychiatric Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| First Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Haerbin | China | Recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Haidian | China | Recruiting |
| Fu Xing Hospital, Capital Medical University Coordinator of this site? Confirm its status | Haidian | China | Recruiting |
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Haidian | China | Recruiting |
| Handan Central Hospital Coordinator of this site? Confirm its status | Handan | China | Recruiting |
| Shao Yifu Hospital of Zhejiang Medical University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Zhejiang Provincial People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| First Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Huangpu | China | Recruiting |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jining | China | Recruiting |
| Kaifeng Central Hospital Coordinator of this site? Confirm its status | Kaifeng | China | Recruiting |
| Ruijin Hospital Coordinator of this site? Confirm its status | Luwan | China | Recruiting |
| Jiangxi Provincial People's Hospital Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Affiliated Hospital of North Sichuan Medical College Coordinator of this site? Confirm its status | Nanchong | China | Recruiting |
| First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Nantong University Affiliated Hospital Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| Ningbo City Medical Treatment Center Lihuili Hospital Coordinator of this site? Confirm its status | Ningbo | China | Recruiting |
| RenJi Hospital Coordinator of this site? Confirm its status | Putong | China | Recruiting |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| Qilu Hospital of Shandong University (Qingdao) Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Recruiting |
| First Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Recruiting |
| First Hospital of Shijiazhuang City Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Subei People's Hospital of Jiangsu Coordinator of this site? Confirm its status | Subei | China | Recruiting |
| The 88th Hospital of PLA Coordinator of this site? Confirm its status | Tai’an | China | Recruiting |
| The First Affiliated Hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Recruiting |
| Tangshan Worker's Hospital Coordinator of this site? Confirm its status | Tangshan | China | Recruiting |
| Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region Coordinator of this site? Confirm its status | Ürümqi | China | Recruiting |
| First Affiliated Hospital of Wenzhou Medical Univeristy Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
| Wuhan University Zhongnan Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Tongji Hospital Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| People's Hospital Affiliated Hubei Medical University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Tang-Du Hospital Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| First Affiliated Hospital Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Recruiting |
| Tianjin Huanhu Hospital Coordinator of this site? Confirm its status | Xianshuigu | China | Recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Xiaobailou | China | Recruiting |
| Peking University First Hospital Coordinator of this site? Confirm its status | Xicheng | China | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Xicheng | China | Recruiting |
| Mineral General Hospital, Xuzhou Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| The People's Hospital of Ningxia Coordinator of this site? Confirm its status | Yinchuan | China | Recruiting |
| General Hospital of Ningxia Medical University Coordinator of this site? Confirm its status | Yinchuan | China | Recruiting |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Yuzhong | China | Recruiting |
| Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Coordinator of this site? Confirm its status | Yuzhong | China | Recruiting |
| People's Hospital of Zhengzhou Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Henan Provincial People's Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Hebei General Hospital Coordinator of this site? Confirm its status | Zhijiazhuang | China | Recruiting |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Zhongshan | China | Recruiting |
| Zigong First People's Hospital Coordinator of this site? Confirm its status | Zigong | China | Recruiting |
Related publications
- Joint impact of pathological burden and cognitive resilience on Alzheimer's disease risk.Nat Med · 2026 · PMID 42728380
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