Alzheimer Disease Clinical Trial
— CFANOfficial title:
A Multi-center Longitudinal Cohort Study of Familial Alzheimer's Disease in China
NCT number | NCT03657732 |
Other study ID # | SYXWJ002 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 10, 2005 |
Est. completion date | January 1, 2038 |
This research will establish and continuously improve the FAD research network in conjunction with multi-center institutions nationwide. By collecting information on the family's demography, genetics, neuropsychology, neuroimaging, biomarkers and other information, we can understand the current FAD population in China, clarify the genetic characteristics, pathogenesis, disease characteristics and diagnosis and treatment status of AD in China; which will lay the foundation for ameliorating clinical diagnosis and treatment, establishing a Chinese FAD clinical database and an international cooperative research platform. 1. To set up a multi-center, nationwide FAD research network and database platform in China 2. To clarify the epidemiological characteristics of FAD in China. 3. To clarify the genetic characteristics of FAD in China. 4. To clarify the clinical characteristics and disease development laws of FAD. 5. To discover and verify the early diagnosis biomarkers of AD. 6. To establish a genetic counseling model.
Status | Recruiting |
Enrollment | 40000 |
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 | Familial Alzheimer's disease group Inclusion criteria: 1. Written informed consent obtained from the participant or a legal guardian prior to any study-related procedures; 2. At least two first-degree relatives in a family have AD (clinically or by testing),and at least 3 out of 2 generations are patients; 3. At least one family member with normal cognitive function (the age should be greater than the average age of onset of the family); 4. Pedigrees carrying FAD pathogenic genes (APP/PSEN1/PSEN2); 5. People in this family >18 years old can be recruited; 6. Participant is cognitively normal or demented but not reaching bedridden level; 7. Participants are able to provide two reliable informants who can provide clinical information; 8. Dementia is diagnosed according to the criteria described by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-R ); 9. 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 ; 10. The diagnosis of MCI is made according to Petersen criteria and the classi?cation is according to the method of Lopez et al. 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 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. Participant has a history of alcoholism or drug abuse; 6. Pregnant or lactating women; 7. No reliable informant; 8. Lumbar puncture exclusion criteria:coagulation disorders or platelet counts < 100,000 cells/µL, lumbar surgery within the last 6 months prior to lumbar puncture that interferes with anatomy of the inter-vertebral spaces, History of chronic or repeated CSF leakage following previous LP(s); 9. MRI Exclusion Criteria: electronic and magnetic metal implants such as pacemakers, artificial heart valve, metal prosthesis, metal joint, etc.; metallic foreign body in the eye; aneurysm clips in the brain. Normal control group 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, Henan 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 |
China,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The prevalence of gene mutations in familial Alzheimer's disease in China. | Gene analysis of known mutations (PSEN1, PSEN2 and APP), apolipoprotein E (APOE) genotype and unknown mutations in familial Alzheimer's disease patients. | An Average of 1 year | |
Primary | The development patterns of genetic, biofluid, imaging, and neuropsychological markers of FAD. | The development patterns of genetic, biofluid, imaging, and neuropsychological markers of FAD. The dynamic changes of biochemical, pathological, structural and functional markers with disease progression. | An Average of 3 to 10 years | |
Secondary | Changes of neuropsychological function in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. | Changes of neuropsychological function measured by neuropsychological assessment battery. | An Average of 1 year | |
Secondary | Changes of brain structure in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. | Changes of structure of the whole brain, hippocampus other brain structures measured by MRI. | An Average of 1 year | |
Secondary | Changes of brain glucose metabolism in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. | Changes of glucose metabolism of the whole brain, hippocampus and other brain structures as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET). | An Average of 1 year | |
Secondary | Changes of brain amyloid deposition in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. | Changes of amyloid deposition of the whole brain, hippocampus and other brain structures as measured by amyloid PET. | An Average of 1 year | |
Secondary | Changes of brain tau deposition in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. | Changes of tau deposition of the whole brain, hippocampus and other brain structures as measured by tau PET. | An Average of 1 year | |
Secondary | Changes of humoral biomarkers in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. | Humoral biomarkers are included Aß42, Aß40, phosphated tau and total tau in plasma, cerebrospinal fluid, saliva, and urine. | Each biomarker with time frame of average 1 year | |
Secondary | 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 1 year |
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