Mild Cognitive Impairment(MCI)COASTNCT03653156
China Cognition and Aging Study
An observational study of Mild Cognitive Impairment(MCI) and Alzheimer Disease, Late Onset, run by Capital Medical University at 65 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD)
- How many people
- 100,000 participants
- Where
- 65 sitesChina
- Study dates
- 1 Jan 2000to 1 Jan 2038
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.).
- Mental and neurodevelopmental retardation.
- Contraindications to MRI.
- Suffering from a disease that cannot be combined with cognitive examination.
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- Refuse to draw blood.
- Refuse to sign the informed consent at baseline
- 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.).
- Mental and neurodevelopmental retardation.
- Contraindications to MRI.
- Suffering from a disease that cannot be combined with cognitive examination.
- Refuse to draw blood.
- Refuse to sign the informed consent at baseline
- 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).
- MRI and laboratory tests do not support or rule out a diagnosis of AD.
- 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.
- Pregnant or lactating women.
- No reliable insiders.
- Refuse to sign the informed consent at baseline.
- 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.
- Contraindications to MRI.
- Refuse to draw blood.
- Refuse to sign informed consent.
- Normal control
- Subjects with abnormal MMSE or MoCA scores.
- 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.).
- Mental and neurodevelopmental retardation.
- Suffering from a disease that cannot be combined with a cognitive examination.
- Contraindications to MRI.
- Refuse to draw blood.
- Refuse to sign the informed consent at baseline.
Trial locations and contacts
65 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jianping Jia, Doctor contact
65 sites in 1 country
China65 sites, 65 recruiting
- Recruiting
Changda Hospital, Anshan
Anshan, Liaoning
Xiu Han, Doctor, ashanxj@163.com
- Recruiting
Baotou Central Hospital
Baotou, Nei Monggol
Furu Liang, Doctor, ru_liang@sina.com
- Recruiting
China-Japan friendship Hospital of Jilin university
Changchun, Jilin
Qin Zhao, Doctor, 1292860277@qq.com
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Li Sun, Doctor, sjnksunli@163.com
- Recruiting
Beijing Geriatric Hospital
Changping, Beijing Municipality
Jihui Lv, lvjihui@139.com
- Recruiting
Beijing Chao Yang Hospital
Chaoyang, Beijing Municipality
Yue Wang, Doctor, wyjoe2000@163.com
- Recruiting
China-Japan Friendship Hospital
Chaoyang, Beijing Municipality
Dantao Peng, pengdantao@medmail.com.cn
- Recruiting
Affiliated Zhongshan hospital of Dalian university
Dalian, Liaoning
Qiang Ma, Doctor, 13332258950@163.com
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning
Cui Wang, Doctor, wangc817@163.com
- Recruiting
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Fengtai, Beijing Municipality
Lanxiang Jin, Doctor, jxlan2001@126.com
- Recruiting
Fujian Medical University Union Hospital
Fujian, Guangdong
Qinyong Ye, unionqyye@163.com
- Recruiting
Guangzhou Psychiatric Hospital
Guangzhou, Guangdong
Mouni Tang, Doctor, munitang@163.com
- Recruiting
The Affiliated Hospital Of Guizhou Medical University
Guiyang, Guizhou
Lan Chu, Doctor, chulan8999@sohu.com
- Recruiting
First Affiliated Hospital of Harbin Medical University
Haerbin, Heilongjiang
Shurong Duan, Doctor, duanshurongsj@163.com
- Recruiting
Chinese PLA General Hospital
Haidian, Beijing Municipality
Jianjun Jia, Doctor, jiajianjun301@126.com
- Recruiting
Fu Xing Hospital, Capital Medical University
Haidian, Beijing Municipality
Fang Li, Doctor, lifangwa@sina.com
- Recruiting
Peking University Third Hospital
Haidian, Beijing Municipality
Weizhong Xiao, weizhongx@sina.com
- Recruiting
Handan Central Hospital
Handan, Hebei
Minchen Kan, Doctor, 623090112@qq.com
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Benyan Luo, Doctor, luobenyan@zju.edu.cn
- Recruiting
Shao Yifu Hospital of Zhejiang Medical University
Hangzhou, Zhejiang
Peilin Lu, Doctor, lplzxa@163.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang
Enyan Yu, yuenyan@aliyun.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Yanghua Tian, Doctor, ayfytyh@126.com
- Recruiting
Shanghai Changzheng Hospital
Huangpu, Shanghai Municipality
Jianhua Zhuang, Doctor, jianhuazh11@126.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Peiyan Shan, Doctor, Shanpy57@163.com
- Recruiting
Shandong Provincial Hospital
Jining, Shandong
Yifeng Du, Doctor, duyifeng2013@163.com
- Recruiting
Kaifeng Central Hospital
Kaifeng, Henan
Huanrong Yu, Doctor, yrh0656@126.com
- Recruiting
Ruijin Hospital
Luwan, Shanghai Municipality
Gang Wang, Doctor, wgneuron@hotmail.com
- Recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
Kunnan Zhang, Doctor, zkn8@163.com
- Recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan
Ying Ma, Doctor, yingma1314@126.com
- Recruiting
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Shengliang Liang, ssl_1964@163.com
- Recruiting
Nantong University Affiliated Hospital
Nantong, Jiangsu
Maohong Cao, Doctor, yty5532917@163.com
- Recruiting
Ningbo City Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang
Guomin Xie, Doctor, drxie01@qq.com
- Recruiting
RenJi Hospital
Putong, Shanghai Municipality
Qun Xu, Doctor, xuqun628@163.com
- Recruiting
Qilu Hospital of Shandong University (Qingdao)
Qingdao, Shandong
Bin Liang, Doctor, bingliangbin@163.com
- Recruiting
QingDao Municipal Hospital
Qingdao, Shandong
Lan Tan, Doctor, dr.tanlan@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Jinping Sun, Doctor, sunjinping@sina.com
- Recruiting
First Hospital of China Medical University
Shenyang, Liaoning
Yunpeng Cao, Doctor, cypcmu@163.com
- Recruiting
First Hospital of Shijiazhuang City
Shijiazhuang, Hebei
Huiying Zhao, 13323119938@163.com
- Recruiting
Subei People's Hospital of Jiangsu
Subei, Jiangsu
Jun Xu, Doctor, 13611572068@126.com
- Recruiting
The 88th Hospital of PLA
Tai’an, Shandong
Jintao Zhang, Doctor, zjtdoctor@126.com
- Recruiting
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi
Yuling Tian, Doctor, tylzcy2018@163.com
- Recruiting
Tangshan Worker's Hospital
Tangshan, Hebei
Yongqiu Li, Doctor, yongqiuli@126.com
- Recruiting
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
Ürümqi, Xinjiang
Xinling Meng, altmxl@126.com
- Recruiting
First Affiliated Hospital of Wenzhou Medical Univeristy
Wenzhou, Zhejiang
Zhen Wang, Jane.wz@163.com
- Recruiting
People's Hospital Affiliated Hubei Medical University
Wuhan, Hubei
Jianjun Zhang, Doctor, xsssm@sina.cn
- Recruiting
Tongji Hospital
Wuhan, Hubei
Min Zhang, 4082410998@qq.com
- Recruiting
The Third Xiangya Hospital of Central South University
Wuhan, Hunan
Lu Shen, shenlu2505@126.com
- Recruiting
Wuhan University Zhongnan Hospital
Wuhan, Hunan
Hanxing Liu, hanxing_liu@whu.Ed.cn
- Recruiting
Xiangya Hospital of Central South University
Wuhan, Hunan
Qiuyun Tu, Doctor, qiuyuntu@126.com
- Recruiting
First Affiliated Hospital Xi'an Jiaotong University
Xi’an, Shanxi
Qiumin Qu, Doctor, quqiumin@medmail.com.cn
- Recruiting
Tang-Du Hospital
Xi’an, Shanxi
Wei Zhang, Doctor, zw711711@hotmail.com
- Recruiting
Tianjin Huanhu Hospital
Xianshuigu, Tianjin Municipality
Yuying Zhou, Doctor, Qiying789@sina.cn
- Recruiting
Tianjin Medical University General Hospital
Xiaobailou, Tianjin Municipality
Nan Zhang, Doctor, nkzhangnan@163.com
- Recruiting
Peking Union Medical College Hospital
Xicheng, Beijing Municipality
Jing Gao, Doctor, gj107@163.com
- Recruiting
Peking University First Hospital
Xicheng, Beijing Municipality
Zhirong Jia, jiazhirong@163.com
- Recruiting
Mineral General Hospital, Xuzhou
Xuzhou, Jiangsu
Liangqun Rong, Doctor, rongliangqun@163.com
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Qin Zhang, Doctor, nxzhangqing@aliyun.com
- Recruiting
The People's Hospital of Ningxia
Yinchuan, Ningxia
Yongying Gao, Doctor, 18169110878@163.com
- Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Yuzhong, Chongqing Municipality
Yanjiang Wang
Yingying Shen, 123473534@qq.com
- Recruiting
The Second Affiliated Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality
Yangmei Chen, chenym1997@tom.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Jiewen Zhang, Doctor, zhangjiewen9900@126.com
- Recruiting
People's Hospital of Zhengzhou
Zhengzhou, Henan
Shuling Zhang, Doctor
Bin Zhang, Zyuanyuan1121@163.com
- Recruiting
Hebei General Hospital
Zhijiazhuang, Hebei
Peiyuan Lv, Doctor, peiyuanlu@163.com
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Zhongshan, Guangdong
Jun Liu, Doctor, docliujun@126.com
- Recruiting
Zigong First People's Hospital
Zigong, Sichuan
Xiaoya Xu, Doctor, 502687651@qq.com
About this study
Official title: China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China
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:
- 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.
- 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.
- To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia).
- 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.
- 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.
- 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.
- 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.
- 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.
- To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia.
- To investigate the level of stigma and discrimination and its influencing factors in patients with Alzheimer's disease and their caregivers.
Read the 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Vascular Dementia (VaD), Normal Control, Non-Alzheimer Degenerative Dementia
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of MCI and AD measured using a population-based cross-sectional survey with a multistage cluster sampling design
Measured: an average of 2 years
The conversion rate of normal to MCI to AD in Chinese
Measured: an average of 2 years
The biomarkers for normal (pre-MCI), MCI and AD diagnosis
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.
Measured: an average of 2 years
The risk factors (genetic and environmental factors) for MCI, AD and VCI at genomic and expression levels
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.
Measured: an average of 2 years
The effective non-pharmacologic treatment(NPT) intervention
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.
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Jan 2000
- Primary completion1 Jan 2038 (estimated)
- Study completion1 Jan 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment(MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- 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, 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, 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
- Responsible party
- Principal investigator, Jianping Jia, Capital Medical University
- Investigators
- Jianping Jia, Doctor, Study chair, Xuanwu Hospital of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653156
- Sponsor's protocol ID
- SYXWJ001
- Acronym
- COAST
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2018
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou A, Jia J. A screen for cognitive assessments for patients with vascular cognitive impairment no dementia. Int J Geriatr Psychiatry. 2009 Dec;24(12):1352-7. doi: 10.1002/gps.2265.
PubMed 19347838Zhou A, Jia J. Different cognitive profiles between mild cognitive impairment due to cerebral small vessel disease and mild cognitive impairment of Alzheimer's disease origin. J Int Neuropsychol Soc. 2009 Nov;15(6):898-905. doi: 10.1017/S1355617709990816.
PubMed 19891819Bai F, Liao W, Watson DR, Shi Y, Yuan Y, Cohen AD, Xie C, Wang Y, Yue C, Teng Y, Wu D, Jia J, Zhang Z. Mapping the altered patterns of cerebellar resting-state function in longitudinal amnestic mild cognitive impairment patients. J Alzheimers Dis. 2011;23(1):87-99. doi: 10.3233/JAD-2010-101533.
PubMed 20930266Han Y, Wang J, Zhao Z, Min B, Lu J, Li K, He Y, Jia J. Frequency-dependent changes in the amplitude of low-frequency fluctuations in amnestic mild cognitive impairment: a resting-state fMRI study. Neuroimage. 2011 Mar 1;55(1):287-95. doi: 10.1016/j.neuroimage.2010.11.059. Epub 2010 Nov 28.
PubMed 21118724Lu J, Li D, Li F, Zhou A, Wang F, Zuo X, Jia XF, Song H, Jia J. Montreal cognitive assessment in detecting cognitive impairment in Chinese elderly individuals: a population-based study. J Geriatr Psychiatry Neurol. 2011 Dec;24(4):184-90. doi: 10.1177/0891988711422528.
PubMed 22228824Shi FD, Jia JP. Neurology and neurologic practice in China. Neurology. 2011 Nov 29;77(22):1986-92. doi: 10.1212/WNL.0b013e31823a0ed3.
PubMed 22123780Han Y, Jia J, Jia XF, Qin W, Wang S. Combination of plasma biomarkers and clinical data for the detection of sporadic Alzheimer's disease. Neurosci Lett. 2012 May 16;516(2):232-6. doi: 10.1016/j.neulet.2012.03.094. Epub 2012 Apr 7.
PubMed 22503901Li F, Jia XF, Jia J. The Informant Questionnaire on Cognitive Decline in the Elderly individuals in screening mild cognitive impairment with or without functional impairment. J Geriatr Psychiatry Neurol. 2012 Dec;25(4):227-32. doi: 10.1177/0891988712464822. Epub 2012 Nov 21.
PubMed 23172761Song J, Wang S, Tan M, Jia J. G1/S checkpoint proteins in peripheral blood lymphocytes are potentially diagnostic biomarkers for Alzheimer's disease. Neurosci Lett. 2012 Sep 27;526(2):144-9. doi: 10.1016/j.neulet.2012.08.020. Epub 2012 Aug 17.
PubMed 22922216Tan M, Wang S, Song J, Jia J. Combination of p53(ser15) and p21/p21(thr145) in peripheral blood lymphocytes as potential Alzheimer's disease biomarkers. Neurosci Lett. 2012 May 16;516(2):226-31. doi: 10.1016/j.neulet.2012.03.093. Epub 2012 Apr 6.
PubMed 22503900Wang F, Shu C, Jia L, Zuo X, Zhang Y, Zhou A, Qin W, Song H, Wei C, Zhang F, Hong Z, Tang M, Wang DM, Jia J. Exploration of 16 candidate genes identifies the association of IDE with Alzheimer's disease in Han Chinese. Neurobiol Aging. 2012 May;33(5):1014.e1-9. doi: 10.1016/j.neurobiolaging.2010.08.004. Epub 2010 Sep 28.
PubMed 20880607Wang S, Song J, Tan M, Albers KM, Jia J. Mitochondrial fission proteins in peripheral blood lymphocytes are potential biomarkers for Alzheimer's disease. Eur J Neurol. 2012 Jul;19(7):1015-22. doi: 10.1111/j.1468-1331.2012.03670.x. Epub 2012 Feb 16.
PubMed 22340708Xing Y, Qin W, Li F, Jia XF, Jia J. Apolipoprotein E epsilon4 status modifies the effects of sex hormones on neuropsychiatric symptoms of Alzheimer's disease. Dement Geriatr Cogn Disord. 2012;33(1):35-42. doi: 10.1159/000336600. Epub 2012 Mar 2.
PubMed 22398564Xing Y, Wei C, Chu C, Zhou A, Li F, Wu L, Song H, Zuo X, Wang F, Qin W, Li D, Tang Y, Jia XF, Jia J. Stage-specific gender differences in cognitive and neuropsychiatric manifestations of vascular dementia. Am J Alzheimers Dis Other Demen. 2012 Sep;27(6):433-8. doi: 10.1177/1533317512454712.
PubMed 22930700Li F, Wang F, Jia J. Evaluating the prevalence of dementia in hospitalized older adults and effects of comorbid dementia on patients' hospital course. Aging Clin Exp Res. 2013 Aug;25(4):393-401. doi: 10.1007/s40520-013-0068-z. Epub 2013 Jul 20.
PubMed 23872925
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China
- ClinicalTrials.gov ID
- NCT03653156
- Acronym / sponsor ID
- COAST / SYXWJ001
- Conditions
- Mild Cognitive Impairment(MCI), Alzheimer Disease, Late Onset, Familial Alzheimer Disease (FAD), Vascular Dementia (VaD), Normal Control, Non-Alzheimer Degenerative Dementia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- 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, 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, 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
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 Jan 2038 (estimated)
- Study completion
- 1 Jan 2038 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia).
- 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.
- 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.
- 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.
- 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.
- 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.
- To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia.
- 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (44 listed)
- 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.).
- Mental and neurodevelopmental retardation.
- Contraindications to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
The conversion rate of normal to MCI to AD in Chinese
Time frame: an average of 2 years
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Results publication: PubMed 19347838Zhou A, Jia J. A screen for cognitive assessments for patients with vascular cognitive impairment no dementia. Int J Geriatr Psychiatry. 2009 Dec;24(12):1352-7. doi: 10.1002/gps.2265.
- Results publication: PubMed 19891819Zhou A, Jia J. Different cognitive profiles between mild cognitive impairment due to cerebral small vessel disease and mild cognitive impairment of Alzheimer's disease origin. J Int Neuropsychol Soc. 2009 Nov;15(6):898-905. doi: 10.1017/S1355617709990816.
- Results publication: PubMed 20930266Bai F, Liao W, Watson DR, Shi Y, Yuan Y, Cohen AD, Xie C, Wang Y, Yue C, Teng Y, Wu D, Jia J, Zhang Z. Mapping the altered patterns of cerebellar resting-state function in longitudinal amnestic mild cognitive impairment patients. J Alzheimers Dis. 2011;23(1):87-99. doi: 10.3233/JAD-2010-101533.
- Results publication: PubMed 21118724Han Y, Wang J, Zhao Z, Min B, Lu J, Li K, He Y, Jia J. Frequency-dependent changes in the amplitude of low-frequency fluctuations in amnestic mild cognitive impairment: a resting-state fMRI study. Neuroimage. 2011 Mar 1;55(1):287-95. doi: 10.1016/j.neuroimage.2010.11.059. Epub 2010 Nov 28.
- Results publication: PubMed 22228824Lu J, Li D, Li F, Zhou A, Wang F, Zuo X, Jia XF, Song H, Jia J. Montreal cognitive assessment in detecting cognitive impairment in Chinese elderly individuals: a population-based study. J Geriatr Psychiatry Neurol. 2011 Dec;24(4):184-90. doi: 10.1177/0891988711422528.
- Results publication: PubMed 22123780Shi FD, Jia JP. Neurology and neurologic practice in China. Neurology. 2011 Nov 29;77(22):1986-92. doi: 10.1212/WNL.0b013e31823a0ed3.
- Results publication: PubMed 22503901Han Y, Jia J, Jia XF, Qin W, Wang S. Combination of plasma biomarkers and clinical data for the detection of sporadic Alzheimer's disease. Neurosci Lett. 2012 May 16;516(2):232-6. doi: 10.1016/j.neulet.2012.03.094. Epub 2012 Apr 7.
- Results publication: PubMed 23172761Li F, Jia XF, Jia J. The Informant Questionnaire on Cognitive Decline in the Elderly individuals in screening mild cognitive impairment with or without functional impairment. J Geriatr Psychiatry Neurol. 2012 Dec;25(4):227-32. doi: 10.1177/0891988712464822. Epub 2012 Nov 21.
- Results publication: PubMed 22922216Song J, Wang S, Tan M, Jia J. G1/S checkpoint proteins in peripheral blood lymphocytes are potentially diagnostic biomarkers for Alzheimer's disease. Neurosci Lett. 2012 Sep 27;526(2):144-9. doi: 10.1016/j.neulet.2012.08.020. Epub 2012 Aug 17.
- Results publication: PubMed 22503900Tan M, Wang S, Song J, Jia J. Combination of p53(ser15) and p21/p21(thr145) in peripheral blood lymphocytes as potential Alzheimer's disease biomarkers. Neurosci Lett. 2012 May 16;516(2):226-31. doi: 10.1016/j.neulet.2012.03.093. Epub 2012 Apr 6.
- Results publication: PubMed 20880607Wang F, Shu C, Jia L, Zuo X, Zhang Y, Zhou A, Qin W, Song H, Wei C, Zhang F, Hong Z, Tang M, Wang DM, Jia J. Exploration of 16 candidate genes identifies the association of IDE with Alzheimer's disease in Han Chinese. Neurobiol Aging. 2012 May;33(5):1014.e1-9. doi: 10.1016/j.neurobiolaging.2010.08.004. Epub 2010 Sep 28.
- Results publication: PubMed 22340708Wang S, Song J, Tan M, Albers KM, Jia J. Mitochondrial fission proteins in peripheral blood lymphocytes are potential biomarkers for Alzheimer's disease. Eur J Neurol. 2012 Jul;19(7):1015-22. doi: 10.1111/j.1468-1331.2012.03670.x. Epub 2012 Feb 16.
- COAST WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianping Jia, Doctor contact
Jianping Jia, Doctor study chair
Xuanwu Hospital of Capital Medical University
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment(MCI) and Alzheimer Disease, Late Onset, run by Capital Medical University at 65 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianping Jia, Doctor (jiajp@vip.126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653156, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.