The Chinese Familial Alzheimer's Network

Recruiting · NCT03657732 · Observational (researchers observe without assigning treatment) · Lead sponsor: Capital Medical University

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Alzheimer's disease

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

Inclusion criteria

Written informed consent obtained from the participant or a legal guardian prior to any study-related procedures;
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;
At least one family member with normal cognitive function (the age should be greater than the average age of onset of the family);
Pedigrees carrying FAD pathogenic genes (APP/PSEN1/PSEN2);
People in this family \>18 years old can be recruited;
Participant is cognitively normal or demented but not reaching bedridden level;
Participants are able to provide two reliable informants who can provide clinical information;
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 ;
The diagnosis of MCI is made according to Petersen criteria and the classiﬁcation is according to the method of Lopez et al.

Exclusion criteria

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)；
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；
Participant has a history of alcoholism or drug abuse；
Pregnant or lactating women；
No reliable informant；
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);
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:
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.
Exclusion criteria:
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.

Where it is running

60 locations listed.

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

Showing 60 of 65 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →