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NCT03657732

The Chinese Familial Alzheimer's Network

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

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.

Official title: A Multi-center Longitudinal Cohort Study of Familial Alzheimer's Disease in China

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

40000

Start Date

2005-01-10

Completion Date

2038-01-01

Last Updated

2026-03-23

Healthy Volunteers

Yes

Conditions

Alzheimer Disease Familial Alzheimer Disease (FAD)

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 classiﬁcation 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.

Locations (65)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Geriatric Hospital

Changping, Beijing Municipality, China

Beijing Chao Yang Hospital

Chaoyang, Beijing Municipality, China

China-Japan Friendship Hospital

Chaoyang, Beijing Municipality, China

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

Fengtai, Beijing Municipality, China

Chinese PLA General Hospital

Haidian, Beijing Municipality, China

Fu Xing Hospital, Capital Medical University

Haidian, Beijing Municipality, China

Peking University Third Hospital

Haidian, Beijing Municipality, China

Peking Union Medical College Hospital

Xicheng, Beijing Municipality, China

Peking University First Hospital

Xicheng, Beijing Municipality, China

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Yuzhong, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Yuzhong, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fujian, Guangdong, China

Guangzhou Psychiatric Hospital

Guangzhou, Guangdong, China

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Zhongshan, Guangdong, China

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Affiliated Hospital Of Guizhou Medical University

Guiyang, Guizhou, China

Handan Central Hospital

Handan, Hebei, China

First Hospital of Shijiazhuang City

Shijiazhuang, Hebei, China

Tangshan Worker's Hospital

Tangshan, Hebei, China

Hebei General Hospital

Zhijiazhuang, Hebei, China

First Affiliated Hospital of Harbin Medical University

Haerbin, Heilongjiang, China

Kaifeng Central Hospital

Kaifeng, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

People's Hospital of Zhengzhou

Zhengzhou, Henan, China

People's Hospital Affiliated Hubei Medical University

Wuhan, Hubei, China

Tongji Hospital

Wuhan, Hubei, China

The Third Xiangya Hospital of Central South University

Wuhan, Hunan, China

Wuhan University Zhongnan Hospital

Wuhan, Hunan, China

Xiangya Hospital of Central South University

Wuhan, Hunan, China

Nantong University Affiliated Hospital

Nantong, Jiangsu, China

Subei People's Hospital of Jiangsu

Subei, Jiangsu, China

Mineral General Hospital, Xuzhou

Xuzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

China-Japan friendship Hospital of Jilin university

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

Changda Hospital, Anshan

Anshan, Liaoning, China

Affiliated Zhongshan hospital of Dalian university

Dalian, Liaoning, China

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

First Hospital of China Medical University

Shenyang, Liaoning, China

Baotou Central Hospital

Baotou, Nei Monggol, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The People's Hospital of Ningxia

Yinchuan, Ningxia, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shandong Provincial Hospital

Jining, Shandong, 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

The 88th Hospital of PLA

Tai’an, Shandong, China

Shanghai Changzheng Hospital

Huangpu, Shanghai Municipality, China

Ruijin Hospital

Luwan, Shanghai Municipality, China

RenJi Hospital

Putong, Shanghai Municipality, China

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

First Affiliated Hospital Xi'an Jiaotong University

Xi’an, Shanxi, China

Tang-Du Hospital

Xi’an, Shanxi, China

Afﬁliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Zigong First People's Hospital

Zigong, Sichuan, China

Tianjin Huanhu Hospital

Xianshuigu, Tianjin Municipality, China

Tianjin Medical University General Hospital

Xiaobailou, Tianjin Municipality, China

Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region

Ürümqi, Xinjiang, 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

Ningbo City Medical Treatment Center Lihuili Hospital

Ningbo, Zhejiang, China

First Affiliated Hospital of Wenzhou Medical Univeristy

Wenzhou, Zhejiang, China

Clinical Research Directory

The Chinese Familial Alzheimer's Network

Summary

Key Details

Conditions

Eligibility Criteria

Locations (65)