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China Cognition and Aging Study (COAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653156
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : April 19, 2024
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Fu Xing Hospital, Capital Medical University
Peking Union Medical College Hospital
Peking University First Hospital
Peking University Third Hospital
Chinese PLA General Hospital
China-Japan Friendship Hospital
Beijing Geriatric Hospital
The First Affiliated Hospital of Dalian Medical University
Fujian Medical University Union Hospital
Guangzhou Psychiatric Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Guangxi Medical University
The Affiliated Hospital Of Guizhou Medical University
Handan Central Hospital
Hebei General Hospital
First Hospital of Shijiazhuang City
Tangshan Worker's Hospital
Hunan Provincial People's Hospital
Kaifeng Central Hospital
People's Hospital of Zhengzhou University
Wuhan University Zhongnan Hospital
First Affiliated Hospital of Harbin Medical University
Tongji Hospital
People's Hospital Affiliated Hubei Medical University
The Third Xiangya Hospital of Central South University
Xiangya Hospital of Central South University
The First Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Subei People's Hospital of Jiangsu
Nantong University Affiliated Hospital
Mineral General Hospital, Xuzhou
Jiangxi Provincial People's Hopital
Anshan Central Hospital
The Affiliated Zhongshan Hospital of Dalian University
First Hospital of China Medical University
Baotou Central Hospital
General Hospital of Ningxia Medical University
The People's Hospital of Ningxia
The Affiliated Hospital of Qingdao University
The 960th Hospital of PLA
Qilu Hospital of Shandong University
Qilu Hospital of Shandong University (Qingdao)
Shandong Provincial Hospital
Qingdao Municipal Hospital
The First Affiliated Hospital of Shanxi Medical University
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
RenJi Hospital
Shanghai Changzheng Hospital
Affiliated Hospital of North Sichuan Medical College
Tianjin Huanhu Hospital
Tianjin Medical University General Hospital
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Zhejiang University
Shao Yifu Hospital of Zhejiang Medical University
Zhejiang Provincial People's Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
The Second Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Anhui Medical University
People's Hospital of Chongqing
Dongfang Hospital Beijing University of Chinese Medicine
Zigong No.1 Peoples Hospital
Information provided by (Responsible Party):
Jianping Jia, Capital Medical University

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.

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

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China
Actual Study Start Date : January 1, 2000
Estimated Primary Completion Date : January 1, 2038
Estimated Study Completion Date : January 1, 2038


Group/Cohort
Mild cognitive impairment (MCI) and its subtypes
MCI cohort consists of mild cognitive impairment subjects with memory loss as predominant symptom, including amnestic mild cognitive impairment and vascular cognitive impairment no dementia, which recruit from community population and hospital population.
Sporadic Alzheimer's disease (SAD)
SAD cohort consists of mild to moderate sporadic Alzheimer's disease subjects, which recruit from community population and hospital population.
Familial Alzheimer's disease (FAD)
FAD cohort consists of familial Alzheimer disease subjects with known or unknown mutations, which recruit from community population and hospital population.
Vascular dementia(VaD)
VaD cohort consists of cognitive impairment subjects caused by cerebral vessel disease, including vascular dementia and mixes dementia, which recruit from community population and hospital population.
Normal control
Normal control cohort consists of cognitive normal subjects with ApoE ε4 positive or negative, which recruit from community population and hospital population.
Non-Alzheimer degenerative dementia
Frontotemporal dementia (FTD); or Parkinson's disease dementia (PDD); or dementia with Lewy bodies (DLB); or corticobasal degeneration (CBD); or dementia not otherwise specified.



Primary Outcome Measures :
  1. The prevalence of MCI and AD measured using a population-based cross-sectional survey with a multistage cluster sampling design [ Time Frame: an average of 2 years ]
  2. The conversion rate of normal to MCI to AD in Chinese [ Time Frame: an average of 2 years ]
  3. The biomarkers for normal (pre-MCI), MCI and AD diagnosis [ Time Frame: an average of 2 years ]
    Humoral 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.

  4. The risk factors (genetic and environmental factors) for MCI, AD and VCI at genomic and expression levels [ Time Frame: an average of 2 years ]
    Discover 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.

  5. The effective non-pharmacologic treatment(NPT) intervention [ Time Frame: an average of 2 years ]
    The 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.


Biospecimen Retention:   Samples With DNA
Plasma, CSF, saliva and biopsy and autopsy


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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.

Exclusion criteria:

  1. With a family history of dementia.
  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

(3) Familial Alzheimer's disease (FAD)

Inclusion criteria:

  1. Written informed consent obtained from participant or legal guardian prior to any study-related procedures.
  2. Members in FAD pedigree (FAD is defined as at least two first- degree relatives suffer from AD).
  3. Aged 18 (inclusive) or older.
  4. 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.

Exclusion criteria:

  1. 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).
  2. MRI and laboratory tests do not support or rule out a diagnosis of AD.
  3. Severe circulatory, respiratory, urinary, digestive, hematopoietic diseases (such as unstable angina, uncontrollable asthma, active gastric bleeding) and cancer.
  4. Participant has severe psychiatric illness or severe dementia that would interfere in completing initial and follow-up clinical assessments.
  5. With history of alcohol or drug abuse.
  6. Pregnant or lactating women.
  7. No reliable insiders.
  8. Refuse to sign the informed consent at baseline.

(4) Vascular dementia (VaD)

Inclusion 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.

  1. 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.
  2. no cortical and watershed infarction, hemorrhage, hydrocephalus, or WML with specific causes (such as multiple sclerosis).
  3. no hippocampus or entorhinal cortex atrophy (MTA score = 0 point).

Exclusion criteria:

  1. 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.).
  2. 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.).
  3. With a history of mental illness or those with congenital mental retardation.
  4. Suffering from a disease that cannot be combined with a cognitive examination.
  5. Contraindications to MRI.
  6. Refuse to draw blood.
  7. Refuse to sign informed consent.

(5) Normal control

Inclusion criteria:

  1. Aged 18 (inclusive) or above.
  2. 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.

Exclusion criteria:

  1. Subjects with abnormal MMSE or MoCA scores.
  2. Subjects with a history of cerebral infarction, traumatic brain injury or related manifestations in MRI.
  3. 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.).
  4. 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.).
  5. Mental and neurodevelopmental retardation.
  6. Suffering from a disease that cannot be combined with a cognitive examination.
  7. Contraindications to MRI.
  8. Refuse to draw blood.
  9. Refuse to sign the informed consent at baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653156


Contacts
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Contact: Jianping Jia, Doctor jiajp@vip.126.com

Locations
Show Show 65 study locations
Sponsors and Collaborators
Capital Medical University
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Fu Xing Hospital, Capital Medical University
Peking Union Medical College Hospital
Peking University First Hospital
Peking University Third Hospital
Chinese PLA General Hospital
China-Japan Friendship Hospital
Beijing Geriatric Hospital
The First Affiliated Hospital of Dalian Medical University
Fujian Medical University Union Hospital
Guangzhou Psychiatric Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Guangxi Medical University
The Affiliated Hospital Of Guizhou Medical University
Handan Central Hospital
Hebei General Hospital
First Hospital of Shijiazhuang City
Tangshan Worker's Hospital
Hunan Provincial People's Hospital
Kaifeng Central Hospital
People's Hospital of Zhengzhou University
Wuhan University Zhongnan Hospital
First Affiliated Hospital of Harbin Medical University
Tongji Hospital
People's Hospital Affiliated Hubei Medical University
The Third Xiangya Hospital of Central South University
Xiangya Hospital of Central South University
The First Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Subei People's Hospital of Jiangsu
Nantong University Affiliated Hospital
Mineral General Hospital, Xuzhou
Jiangxi Provincial People's Hopital
Anshan Central Hospital
The Affiliated Zhongshan Hospital of Dalian University
First Hospital of China Medical University
Baotou Central Hospital
General Hospital of Ningxia Medical University
The People's Hospital of Ningxia
The Affiliated Hospital of Qingdao University
The 960th Hospital of PLA
Qilu Hospital of Shandong University
Qilu Hospital of Shandong University (Qingdao)
Shandong Provincial Hospital
Qingdao Municipal Hospital
The First Affiliated Hospital of Shanxi Medical University
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
RenJi Hospital
Shanghai Changzheng Hospital
Affiliated Hospital of North Sichuan Medical College
Tianjin Huanhu Hospital
Tianjin Medical University General Hospital
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Zhejiang University
Shao Yifu Hospital of Zhejiang Medical University
Zhejiang Provincial People's Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
The Second Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Anhui Medical University
People's Hospital of Chongqing
Dongfang Hospital Beijing University of Chinese Medicine
Zigong No.1 Peoples Hospital
Investigators
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Study Chair: Jianping Jia, Doctor Xuanwu Hospital of Capital Medical University
  Study Documents (Full-Text)

Documents provided by Jianping Jia, Capital Medical University:
Study Protocol  [PDF] June 30, 2020

Additional Information:
Publications of Results:

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Responsible Party: Jianping Jia, Chief Director, Capital Medical University
ClinicalTrials.gov Identifier: NCT03653156    
Other Study ID Numbers: SYXWJ001
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Dementia, Vascular
Late Onset Disorders
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Disease Attributes
Pathologic Processes