Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (65)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Changda Hospital, Anshan
Coordinator of this site? Confirm its status
AnshanChinaRecruiting
Baotou Central Hospital
Coordinator of this site? Confirm its status
BaotouChinaRecruiting
China-Japan friendship Hospital of Jilin university
Coordinator of this site? Confirm its status
ChangchunChinaRecruiting
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaRecruiting
Beijing Geriatric Hospital
Coordinator of this site? Confirm its status
ChangpingChinaRecruiting
China-Japan Friendship Hospital
Coordinator of this site? Confirm its status
ChaoyangChinaRecruiting
Beijing Chao Yang Hospital
Coordinator of this site? Confirm its status
ChaoyangChinaRecruiting
The First Affiliated Hospital of Dalian Medical University
Coordinator of this site? Confirm its status
DalianChinaRecruiting
Affiliated Zhongshan Hospital of Dalian University
Coordinator of this site? Confirm its status
DalianChinaRecruiting
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Coordinator of this site? Confirm its status
FengtaiChinaRecruiting
Fujian Medical University Union Hospital
Coordinator of this site? Confirm its status
FujianChinaRecruiting
Guangzhou Psychiatric Hospital
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
The Affiliated Hospital of Guizhou Medical University
Coordinator of this site? Confirm its status
GuiyangChinaRecruiting
First Affiliated Hospital of Harbin Medical University
Coordinator of this site? Confirm its status
HaerbinChinaRecruiting
Peking University Third Hospital
Coordinator of this site? Confirm its status
HaidianChinaRecruiting
Fu Xing Hospital, Capital Medical University
Coordinator of this site? Confirm its status
HaidianChinaRecruiting
Chinese PLA General Hospital
Coordinator of this site? Confirm its status
HaidianChinaRecruiting
Handan Central Hospital
Coordinator of this site? Confirm its status
HandanChinaRecruiting
Shao Yifu Hospital of Zhejiang Medical University
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Zhejiang Provincial People's Hospital
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
First Affiliated Hospital of Zhejiang University
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
The First Affiliated Hospital of Anhui Medical University
Coordinator of this site? Confirm its status
HefeiChinaRecruiting
Shanghai Changzheng Hospital
Coordinator of this site? Confirm its status
HuangpuChinaRecruiting
Qilu Hospital of Shandong University
Coordinator of this site? Confirm its status
JinanChinaRecruiting
Shandong Provincial Hospital
Coordinator of this site? Confirm its status
JiningChinaRecruiting
Kaifeng Central Hospital
Coordinator of this site? Confirm its status
KaifengChinaRecruiting
Ruijin Hospital
Coordinator of this site? Confirm its status
LuwanChinaRecruiting
Jiangxi Provincial People's Hospital
Coordinator of this site? Confirm its status
NanchangChinaRecruiting
Affiliated Hospital of North Sichuan Medical College
Coordinator of this site? Confirm its status
NanchongChinaRecruiting
First Affiliated Hospital of Guangxi Medical University
Coordinator of this site? Confirm its status
NanningChinaRecruiting
Nantong University Affiliated Hospital
Coordinator of this site? Confirm its status
NantongChinaRecruiting
Ningbo City Medical Treatment Center Lihuili Hospital
Coordinator of this site? Confirm its status
NingboChinaRecruiting
RenJi Hospital
Coordinator of this site? Confirm its status
PutongChinaRecruiting
QingDao Municipal Hospital
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting
Qilu Hospital of Shandong University (Qingdao)
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting
The Affiliated Hospital of Qingdao University
Coordinator of this site? Confirm its status
QingdaoChinaRecruiting
First Hospital of China Medical University
Coordinator of this site? Confirm its status
ShenyangChinaRecruiting
First Hospital of Shijiazhuang City
Coordinator of this site? Confirm its status
ShijiazhuangChinaRecruiting
Subei People's Hospital of Jiangsu
Coordinator of this site? Confirm its status
SubeiChinaRecruiting
The 88th Hospital of PLA
Coordinator of this site? Confirm its status
Tai’anChinaRecruiting
The First Affiliated Hospital of Shanxi Medical University
Coordinator of this site? Confirm its status
TaiyuanChinaRecruiting
Tangshan Worker's Hospital
Coordinator of this site? Confirm its status
TangshanChinaRecruiting
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
Coordinator of this site? Confirm its status
ÜrümqiChinaRecruiting
First Affiliated Hospital of Wenzhou Medical Univeristy
Coordinator of this site? Confirm its status
WenzhouChinaRecruiting
Wuhan University Zhongnan Hospital
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
The Third Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Tongji Hospital
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
People's Hospital Affiliated Hubei Medical University
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Xiangya Hospital of Central South University
Coordinator of this site? Confirm its status
WuhanChinaRecruiting
Tang-Du Hospital
Coordinator of this site? Confirm its status
Xi’anChinaRecruiting
First Affiliated Hospital Xi'an Jiaotong University
Coordinator of this site? Confirm its status
Xi’anChinaRecruiting
Tianjin Huanhu Hospital
Coordinator of this site? Confirm its status
XianshuiguChinaRecruiting
Tianjin Medical University General Hospital
Coordinator of this site? Confirm its status
XiaobailouChinaRecruiting
Peking University First Hospital
Coordinator of this site? Confirm its status
XichengChinaRecruiting
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
XichengChinaRecruiting
Mineral General Hospital, Xuzhou
Coordinator of this site? Confirm its status
XuzhouChinaRecruiting
The People's Hospital of Ningxia
Coordinator of this site? Confirm its status
YinchuanChinaRecruiting
General Hospital of Ningxia Medical University
Coordinator of this site? Confirm its status
YinchuanChinaRecruiting
The Second Affiliated Hospital of Chongqing Medical University
Coordinator of this site? Confirm its status
YuzhongChinaRecruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Coordinator of this site? Confirm its status
YuzhongChinaRecruiting
People's Hospital of Zhengzhou
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting
Henan Provincial People's Hospital
Coordinator of this site? Confirm its status
ZhengzhouChinaRecruiting
Hebei General Hospital
Coordinator of this site? Confirm its status
ZhijiazhuangChinaRecruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Coordinator of this site? Confirm its status
ZhongshanChinaRecruiting
Zigong First People's Hospital
Coordinator of this site? Confirm its status
ZigongChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.