The Chinese Familial Alzheimer's Network
- Conditions
- Alzheimer DiseaseFamilial Alzheimer Disease (FAD)
- Registration Number
- NCT03657732
- Lead Sponsor
- Capital Medical University
- Brief 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.
- Detailed Description
1. The network and database include ADAD cohort of the known mutations of PSEN1, PSEN2 and APP (mutation carriers and noncarriers; pre-symptomatic and symptomatic) and unknown mutations cohort.
2. Conduct a comprehensive FAD epidemiological survey in China to clarify the impact of different nationalities, regions, gender, age, living environment (rural/urban), education level, etc. on the occurrence and development of the disease.
3. This project is to discover new FAD mutation sites，pathogenic genes, to protective genes, to explore the pathogenic and protective mechanism, to analyze the disease development laws of families with different sizes of FAD in China, and to clarify the frequency distribution of mutant genes in the Chinese FAD population.
4. The project will collect and regularly follow-up the samples (blood, urine and saliva etc.) and data (neuropsychology, imaging etc.) in the cohort. Emphasis is placed on the occurrence and development of asymptomatic mutant gene carriers from asymptomatic to symptomatic periods.
5. In the FAD family cohort, we will screen high-sensitivity and high-specificity body fluid markers suitable for Chinese people, verify in the SAD cohort, and establish a prediction model of body fluid markers for AD occurrence and disease progression; use structural MRI, dual tracer 18F-FDG PET and 11C-PIB PET multimodal imaging technology, dynamically monitor the dynamic evolution of imaging biomarkers such as brain structure, glucose metabolism and Aβ deposition at various stages of AD progression.
6. We will combine with the genetic characteristics of Chinese FAD to analyze the impact of lifestyle, physical exercise, nootropic drugs, cognitive training, etc. on the disease progression of FAD patients or asymptomatic mutant gene carriers, to establish a genetic counseling model.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40000
Not provided
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The prevalence of gene mutations in familial Alzheimer's disease in China. An Average of 1 year Gene analysis of known mutations (PSEN1, PSEN2 and APP), apolipoprotein E (APOE) genotype and unknown mutations in familial Alzheimer's disease patients.
The development patterns of genetic, biofluid, imaging, and neuropsychological markers of FAD. An Average of 3 to 10 years 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.
- Secondary Outcome Measures
Name Time Method The effective non-pharmacologic treatment(NPT) intervention An Average of 1 year 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.
Changes of brain structure in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. An Average of 1 year Changes of structure of the whole brain, hippocampus other brain structures measured by MRI.
Changes of brain amyloid deposition in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. An Average of 1 year Changes of amyloid deposition of the whole brain, hippocampus and other brain structures as measured by amyloid PET.
Changes of brain tau deposition in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. An Average of 1 year Changes of tau deposition of the whole brain, hippocampus and other brain structures as measured by tau PET.
Changes of humoral biomarkers in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. Each biomarker with time frame of average 1 year Humoral biomarkers are included Aβ42, Aβ40, phosphated tau and total tau in plasma, cerebrospinal fluid, saliva, and urine.
Changes of neuropsychological function in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. An Average of 1 year Changes of neuropsychological function measured by neuropsychological assessment battery.
Changes of brain glucose metabolism in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China. An Average of 1 year Changes of glucose metabolism of the whole brain, hippocampus and other brain structures as measured by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET).
Trial Locations
- Locations (65)
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Beijing Geriatric Hospital
🇨🇳Changping, Beijing, China
China-Japan Friendship Hospital
🇨🇳Chaoyang, Beijing, China
Fu Xing Hospital, Capital Medical University
🇨🇳Haidian, Beijing, China
Peking University Third Hospital
🇨🇳Haidian, Beijing, China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
🇨🇳Yuzhong, Chongqing, China
Tangshan Worker's Hospital
🇨🇳Tangshan, Hebei, China
Hebei General Hospital
🇨🇳Zhijiazhuang, Hebei, China
People's Hospital of Zhengzhou
🇨🇳Zhengzhou, Henan, China
Guangzhou Psychiatric Hospital
🇨🇳Guangzhou, Guangdong, China
Chinese PLA General Hospital
🇨🇳Haidian, Beijing, China
The Third Xiangya Hospital of Central South University
🇨🇳Wuhan, Hunan, China
Subei People's Hospital of Jiangsu
🇨🇳Subei, Jiangsu, China
Beijing Chao Yang Hospital
🇨🇳Chaoyang, Beijing, China
Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
🇨🇳Fengtai, Beijing, China
Peking Union Medical College Hospital
🇨🇳Xicheng, Beijing, 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 Second Affiliated Hospital of Chongqing Medical University
🇨🇳Yuzhong, Chongqing, China
Handan Central Hospital
🇨🇳Handan, Hebei, China
Kaifeng Central Hospital
🇨🇳Kaifeng, Henan, China
Wuhan University Zhongnan Hospital
🇨🇳Wuhan, Hunan, China
Mineral General Hospital, Xuzhou
🇨🇳Xuzhou, Jiangsu, China
The Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Fujian Medical University Union Hospital
🇨🇳Fujian, Guangdong, 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
Baotou Central Hospital
🇨🇳Baotou, Nei Monggol, China
QingDao Municipal Hospital
🇨🇳Qingdao, Shandong, China
The 88th Hospital of PLA
🇨🇳Tai'an, Shandong, China
The First Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The People's Hospital of Ningxia
🇨🇳Yinchuan, Ningxia, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
The Affiliated Hospital Of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
First Hospital of Shijiazhuang City
🇨🇳Shijiazhuang, Hebei, China
First Affiliated Hospital of Harbin Medical University
🇨🇳Haerbin, Heilongjiang, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Nantong University Affiliated Hospital
🇨🇳Nantong, Jiangsu, China
Jiangxi Provincial People's Hospital
🇨🇳Nanchang, Jiangxi, China
China-Japan friendship Hospital of Jilin university
🇨🇳Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Qilu Hospital of Shandong University (Qingdao)
🇨🇳Qingdao, Shandong, China
RenJi Hospital
🇨🇳Putong, Shanghai, China
Tianjin Huanhu Hospital
🇨🇳Jinnan, Tianjin, China
People's Hospital Affiliated Hubei Medical University
🇨🇳Wuhan, Hubei, China
Xiangya Hospital of Central South University
🇨🇳Wuhan, Hunan, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong Provincial Hospital
🇨🇳Jining, Shandong, China
Shanghai Changzheng Hospital
🇨🇳Huangpu, Shanghai, China
First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Ruijin Hospital
🇨🇳Luwan, Shanghai, 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 Medical University General Hospital
🇨🇳Heping, Tianjin, China
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
🇨🇳Urumqi, Xinjiang, China
First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Shao Yifu Hospital of Zhejiang Medical University
🇨🇳Hangzhou, Zhejiang, China
First Affiliated Hospital of Wenzhou Medical Univeristy
🇨🇳Wenzhou, Zhejiang, China
Ningbo City Medical Treatment Center Lihuili Hospital
🇨🇳Ningbo, Zhejiang, China
Peking University First Hospital
🇨🇳Xicheng, Beijing, China