Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 31, 2018
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
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 88th 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 First People's Hospital
Information provided by (Responsible Party):
Jianping Jia, Capital Medical University

Brief Summary:

The Cognition and Aging Study (COAST) was designed to establish a prospective cohort to clarify the clinical and genetic characteristics, pathogenesis, diagnosis, treatment of MCI, AD, and VCI in China to establish a national database, to develop a strategy for prevention of dementia. The overarching goals of the COAST are as follow:

  1. To construct a prospective cohort, then to establish database that provide not only comprehensive epidemiological data on the AD and dementia of Chinese elders, but also biological samples and laboratory and image data.
  2. To determine the conversion rates from MCI to dementia or AD and risk factors for the progression from MCI to dementia or AD.
  3. To identify and validate imaging and blood/CSF biomarkers for the early detection and tracking of AD.
  4. To uncover novel risk genes for complex AD and identify the genes related pathogenesis of the disease.

Condition or disease
Mild Cognitive Impairment Alzheimer Disease, Late Onset Familial Alzheimer Disease (FAD) Vascular Cognitive Impairment APOE Gene Cohort (Cognitive Normal Subjects)

Detailed Description:

This study involved participants including amnestic mild cognitive impairment (aMCI), sporadic Alzheimer's disease (SAD), familial Alzheimer's disease (FAD), Vascular cognitive impairment (VCI), and APOE gene cohort (cognitive normal subjects). Research contents are as follow:

  1. Neuropsychological characteristics of Chinese aMCI, SAD, VCI: analyze the cognitive function, daily living ability and mental behavior symptoms using MMSE, MoCA, etc. during the baseline and follow-up period.
  2. Neuroimaging of Chinese aMCI, SAD, and VCI: explore the neuroimaging characteristics and disease evolution characteristics through the apocalyptic atrophy, cortical thickness of structure MRI, and standardized uptake values of functional imaging FDG-PET.
  3. Prevention of Chinese aMCI, SAD, and VCI: find the risk factors and environmental factors which were possible related to development of these disease, and propose a preventional strategy for dementia in China.
  4. Pathogenesis of Chinese aMCI, SAD, and VCI: test the investigator's findings (risk factors, genetic factors, environmental factors) in this cohort on animal models.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China
Actual Study Start Date : January 10, 2008
Estimated Primary Completion Date : January 1, 2028
Estimated Study Completion Date : January 1, 2028


Group/Cohort
Amnestic mild cognitive impairment (MCI)
Mild cognitive impairment subjects with memory loss as predominant symptom
Sporadic Alzheimer's disease (SAD)
Mild to moderate sporadic Alzheimer's disease subjects
Familial Alzheimer's disease (FAD)
Familial Alzheimer disease subjects with known or unknown mutations
Vascular cognitive impairment (VCI)
Cognitive impairment subjects caused by cerebral small vessel disease, including vascular cognitive impairment no dementia, vascular dementia, mixes dementia
APOE gene cohort
Cognitive normal subjects with ApoE ε4 positive or negative



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.


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.


Layout table for eligibility information
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
Amnestic mild cognitive impairment (aMCI) Sporadic Alzheimer's disease (SAD) Familial Alzheimer's disease (FAD) Vascular cognitive impairment (VCI) APOE gene cohort
Criteria

Amnestic mild cognitive impairment (aMCI)

Inclusion Criteria:

  1. Diagnosis according to 2004 Peterson's aMCI criteria.
  2. Clinical Dementia Rating (CDR) = 0.5.
  3. Memory loss is prominent, and may also be with other cognitive domain impairment.
  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 vascular 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. Other diseases known to cause cognitive impairment.
  6. Contraindications to nuclear magnetics.
  7. Suffering from a disease that cannot be combined with cognitive examination.
  8. Refuse to draw blood.
  9. Refuse to sign the informed consent at baseline

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 Assocation (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. Other diseases known to cause cognitive impairment.
  6. Contraindications to nuclear magnetics.
  7. Suffering from a disease that cannot be combined with cognitive examination.
  8. Refuse to draw blood.
  9. Refuse to sign the informed consent at baseline

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 who carry mutations or not carry mutations in familial Alzheimer's disease pedigree (familial Alzheimer disease is defined as at least two first- degree relatives).
  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 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 Assocation (NIA-AA) criteria. A diagnosis of mild cognitive impairment (MCI) is assigned according to Petersen criteria.

Exclusion Criteria:

  1. Under age 18.
  2. Medical or psychiatric illness that would interfere in completing initial and follow-up visits.
  3. No one who can serve as a study informant.
  4. With current or past neurological or psychiatric illnesses such as schizophrenia, epilepsy, brain tumors, severe head trauma and other diseases which can induce dementia.
  5. With history of alcohol or drug abuse.

Vascular cognitive impairment (VCI)

Inclusion Criteria:

  1. Diagnosis according to the criteria for small vessel VCI, with the following three core elements:

    1. Cognitive impairment: memory decline can be highlighted
    2. Vascular factors
    3. Causal relationship between cognitive impairment and vascular factors
  2. Cognitive impairment lasts for 3 months or more, and the CDR global score ≥0.5 point.
  3. All patients need to meet the following MRI criteria:

    1. Multiple (≥3) small infarcts (3-20 mm in diameter) with or without any degree of white matter lesions (WML); or moderate to severe WML (Fazekas score ≥ 2) , with or without small infarction; or ≥ 1 small infarct in key parts of the cortex, such as: caudate nucleus, globus pallidus, thalamus and so on.
    2. No WML caused by cortical infarction, watershed infarction, hemorrhage, hydrocephalus, or other causes (such as multiple sclerosis).
    3. No hippocampus or entorhinal cortex atrophy, Medial Temporal Lobe Atrophy (MTA)≤ 1 point.
  4. Subjects and their informed persons can complete relevant and follow-up examinations.
  5. Subjects or their authorized legal guardians sign the informed consent.

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, renal, and thyroid insufficiency, severe anemia, folic acid or vitamin B12 deficiency, syphilis, HIV infection, alcohol and drug abuse, etc.).
  3. Other diseases known to cause cognitive impairment.
  4. Hereditary or inflammatory small vessel disease, such as cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL).
  5. Contraindications to nuclear magnetics.
  6. Refuse to draw blood.
  7. Refuse to sign the informed consent at baseline.

APOE gene cohort

Inclusion Criteria:

  1. Aged 18 (inclusive) or older.
  2. APOE genotyping has to be obtained from all subjects.
  3. 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 confirmed by MRI imaging.
  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. Other diseases known to cause cognitive impairment.
  7. Contraindications to nuclear magnetics.
  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
Layout table for location contacts
Contact: Jianping Jia, Doctor jiajp@vip.126.com

  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
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 88th 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 First People's Hospital
Investigators
Layout table for investigator information
Study Chair: Jianping Jia, Doctor Xuanwu Hospital of Capital Medical University

Additional Information:
Publications of Results:

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

Layout table for additional information
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
Late Onset Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Disease Attributes
Cognitive Dysfunction
Dementia
Tauopathies
Pathologic Processes