Alzheimer Disease, Late Onset Clinical Trial
— COASTOfficial title:
China Cognition and Aging Study: a Multi-center, National-wide, Longitudinal Study in China
NCT number | NCT03653156 |
Other study ID # | SYXWJ001 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2000 |
Est. completion date | January 1, 2038 |
The aim of this study is to establish and perfect the China Cognition and Aging Study (China COAST) cohort, to clarify the epidemiology, influencing factors, genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of dementia and its subtypes in China. It is of great significance to establish a relatively comprehensive national database of cognitive disorders, improve the clinical diagnosis and treatment level of cognitive disorders, and formulate prevention and treatment strategies for dementia. The primary aims of China COAST are as follows: 1. To use the prospective cohort to establish a large database research platform, so as to provide comprehensive epidemiological data, clinical and neuropsychological evaluation data, biological samples, and laboratory tests and imaging data. 2. To update the prevalence and incidence rate of dementia and its subtypes every 2-3 years, and clarify the conversion pattern from normal elderly to MCI and from MCI to dementia. 3. To explore the known or unknown protective and risk factors of dementia and its major subtypes (AD, VaD, other dementia). 4. To discover new pathogenic genes and susceptible genes of dementia and its major subtypes (AD and VaD), as well as new mutation sites of known pathogenic genes. To study the genetic variation, mutation and polymorphism of PSEN1, PSEN2, APP and APOE genes in dementia patients, and to understand their distribution and roles in the pathogenesis. 5. To study the biomarkers (body fluid, genetics, imaging) with diagnostic value of MCI, AD (sporadic and familial) and VaD, to define their cut-off values, and to establish prediction models. 6. To study the diagnostic criteria of cognitive normal, MCI, dementia and their subtypes (clinical and molecular subtypes) in the cohort, and to make psychological assessment scales with high sensitivity and specificity, and in line with the characteristics of Chinese people. 7. To find potentially modifiable risk factors for dementia and to study the prevention and intervention effect of non-pharmacological treatment on APOE ε4 carriers, MCI and AD or other dementia patients,which included improvements in education, nutrition, health care, and lifestyle changes. This needs a long time follow-up. 8. To explore the relationship between dementia as well as its major subtype AD and cerebral and systemetic circulatory disorders (for example, mixed dmentia), as well as potential therapeutic strategies. 9. To carry out investigation and researches about dementia related education, improve the awareness of dementia, and strengthen the management of dementia. 10. To investigate the level of stigma and discrimination and its influencing factors in patients with Alzheimer's disease and their caregivers.
Status | Recruiting |
Enrollment | 100000 |
Est. completion date | January 1, 2038 |
Est. primary completion date | January 1, 2038 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Changda Hospital, Anshan | Anshan | Liaoning |
China | Baotou Central Hospital | Baotou | Nei Monggol |
China | China-Japan friendship Hospital of Jilin university | Changchun | Jilin |
China | The First Hospital of Jilin University | Changchun | Jilin |
China | Beijing Geriatric Hospital | Changping | Beijing |
China | Beijing Chao Yang Hospital | Chaoyang | Beijing |
China | China-Japan Friendship Hospital | Chaoyang | Beijing |
China | Affiliated Zhongshan hospital of Dalian university | Dalian | Liaoning |
China | The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
China | Dongfang Hospital Affiliated to Beijing University of Chinese Medicine | Fengtai | Beijing |
China | Fujian Medical University Union Hospital | Fujian | Guangdong |
China | Guangzhou Psychiatric Hospital | Guangzhou | Guangdong |
China | The Affiliated Hospital Of Guizhou Medical University | Guiyang | Guizhou |
China | First Affiliated Hospital of Harbin Medical University | Haerbin | Heilongjiang |
China | Chinese PLA General Hospital | Haidian | Beijing |
China | Fu Xing Hospital, Capital Medical University | Haidian | Beijing |
China | Peking University Third Hospital | Haidian | Beijing |
China | Handan Central Hospital | Handan | Hebei |
China | First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
China | Shao Yifu Hospital of Zhejiang Medical University | Hangzhou | Zhejiang |
China | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang |
China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
China | Tianjin Medical University General Hospital | Heping | Tianjin |
China | Shanghai Changzheng Hospital | Huangpu | Shanghai |
China | Qilu Hospital of Shandong University | Jinan | Shandong |
China | Shandong Provincial Hospital | Jining | Shandong |
China | Tianjin Huanhu Hospital | Jinnan | Tianjin |
China | Kaifeng Central Hospital | Kaifeng | Henan |
China | Ruijin Hospital | Luwan | Shanghai |
China | Jiangxi Provincial People's Hospital | Nanchang | Jiangxi |
China | Af?liated Hospital of North Sichuan Medical College | Nanchong | Sichuan |
China | First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi |
China | Nantong University Affiliated Hospital | Nantong | Jiangsu |
China | Ningbo City Medical Treatment Center Lihuili Hospital | Ningbo | Zhejiang |
China | RenJi Hospital | Putong | Shanghai |
China | Qilu Hospital of Shandong University (Qingdao) | Qingdao | Shandong |
China | QingDao Municipal Hospital | Qingdao | Shandong |
China | The Affiliated Hospital of Qingdao University | Qingdao | Shandong |
China | First Hospital of China Medical University | Shenyang | Liaoning |
China | First Hospital of Shijiazhuang City | Shijiazhuang | Hebei |
China | Subei People's Hospital of Jiangsu | Subei | Jiangsu |
China | The 88th Hospital of PLA | Tai'an | Shandong |
China | The First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | Tangshan Worker's Hospital | Tangshan | Hebei |
China | Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region | Urumqi | Xinjiang |
China | First Affiliated Hospital of Wenzhou Medical Univeristy | Wenzhou | Zhejiang |
China | People's Hospital Affiliated Hubei Medical University | Wuhan | Hubei |
China | The Third Xiangya Hospital of Central South University | Wuhan | Hunan |
China | Tongji Hospital | Wuhan | Hubei |
China | Wuhan University Zhongnan Hospital | Wuhan | Hunan |
China | Xiangya Hospital of Central South University | Wuhan | Hunan |
China | First Affiliated Hospital Xi'an Jiaotong University | Xi'an | Shanxi |
China | Tang-Du Hospital | Xi'an | Shanxi |
China | Peking Union Medical College Hospital | Xicheng | Beijing |
China | Peking University First Hospital | Xicheng | Beijing |
China | Mineral General Hospital, Xuzhou | Xuzhou | Jiangsu |
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
China | The People's Hospital of Ningxia | Yinchuan | Ningxia |
China | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University | Yuzhong | Chongqing |
China | The Second Affiliated Hospital of Chongqing Medical University | Yuzhong | Chongqing |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
China | People's Hospital of Zhengzhou | Zhengzhou | Henan |
China | Hebei General Hospital | Zhijiazhuang | Hebei |
China | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Zhongshan | Guangdong |
China | Zigong First People's Hospital | Zigong | Sichuan |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University | Af?liated Hospital of North Sichuan Medical College, Anshan Central Hospital, Baotou Central Hospital, Beijing Chao Yang Hospital, Beijing Geriatric Hospital, Beijing Tiantan Hospital, China-Japan Friendship Hospital, China-Japan Union Hospital, Jilin University, Chinese PLA General Hospital, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Dongfang Hospital Beijing University of Chinese Medicine, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital Xi'an Jiaotong University, First Hospital of China Medical University, First Hospital of Shijiazhuang City, Fu Xing Hospital, Capital Medical University, Fujian Medical University Union Hospital, General Hospital of Ningxia Medical University, Guangzhou Psychiatric Hospital, Handan Central Hospital, Hebei General Hospital, Hunan Provincial People's Hospital, Jiangxi Provincial People's Hopital, Kaifeng Central Hospital, Mineral General Hospital, Xuzhou, Nantong University Affiliated Hospital, Ningbo Medical Center Lihuili Hospital, Peking Union Medical College Hospital, Peking University First Hospital, Peking University Third Hospital, People's Hospital Affiliated Hubei Medical University, People's Hospital of Chongqing, People's Hospital of Zhengzhou University, Qilu Hospital of Shandong University, Qilu Hospital of Shandong University (Qingdao), Qingdao Municipal Hospital, RenJi Hospital, Ruijin Hospital, Shandong Provincial Hospital, Shanghai Changzheng Hospital, Shao Yifu Hospital of Zhejiang Medical University, Subei People's Hospital of Jiangsu, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Tang-Du Hospital, Tangshan Worker's Hospital, The 960th Hospital of PLA, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Hospital of Qingdao University, The Affiliated Zhongshan Hospital of Dalian University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of Shanxi Medical University, The First Hospital of Jilin University, The People's Hospital of Ningxia, The Second Affiliated Hospital of Chongqing Medical University, The Third Xiangya Hospital of Central South University, Tianjin Huanhu Hospital, Tianjin Medical University General Hospital, Tongji Hospital, Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region, Wuhan University Zhongnan Hospital, Xiangya Hospital of Central South University, Zhejiang Provincial People's Hospital, Zigong No.1 Peoples Hospital |
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* Note: There are 45 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prevalence of MCI and AD measured using a population-based cross-sectional survey with a multistage cluster sampling design | an average of 2 years | ||
Primary | The conversion rate of normal to MCI to AD in Chinese | an average of 2 years | ||
Primary | The biomarkers for normal (pre-MCI), MCI and AD diagnosis | Humoral biomarkers are included Aß42, Aß40, 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. | an average of 2 years | |
Primary | 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. | an average of 2 years | |
Primary | 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 e4 carriers, MCI and dementia patients using questionnaire. | an average of 2 years |
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