The Chinese Familial Alzheimer's Network (CFAN)

October 31, 2023 updated by: Jianping Jia, Capital Medical University

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

40000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Changping, Beijing, China
        • Recruiting
        • Beijing Geriatric Hospital
        • Contact:
      • Chaoyang, Beijing, China
      • Chaoyang, Beijing, China
        • Recruiting
        • Beijing Chao Yang Hospital
        • Contact:
      • Fengtai, Beijing, China
        • Recruiting
        • Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
        • Contact:
      • Haidian, Beijing, China
      • Haidian, Beijing, China
        • Recruiting
        • Fu Xing Hospital, Capital Medical University
        • Contact:
      • Haidian, Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Xicheng, Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
      • Xicheng, Beijing, China
        • Recruiting
        • Peking University First Hospital
        • Contact:
    • Chongqing
      • Yuzhong, Chongqing, China
        • Recruiting
        • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
        • Contact:
          • Yanjiang Wang
        • Contact:
      • Yuzhong, Chongqing, China
        • Recruiting
        • The Second Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Guangdong
      • Fujian, Guangdong, China
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou Psychiatric Hospital
        • Contact:
      • Zhongshan, Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • Recruiting
        • First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • The Affiliated Hospital Of GuiZhou Medical University
        • Contact:
    • Hebei
      • Handan, Hebei, China
        • Recruiting
        • HanDan Central Hospital
        • Contact:
      • Shijiazhuang, Hebei, China
        • Recruiting
        • First Hospital of Shijiazhuang City
        • Contact:
      • Tangshan, Hebei, China
        • Recruiting
        • Tangshan Worker's Hospital
        • Contact:
      • Zhijiazhuang, Hebei, China
        • Recruiting
        • Hebei General Hospital
        • Contact:
    • Heilongjiang
      • Haerbin, Heilongjiang, China
        • Recruiting
        • First Affiliated Hospital of Harbin Medical University
        • Contact:
    • Henan
      • Kaifeng, Henan, China
        • Recruiting
        • Kaifeng Central Hospital
        • Contact:
      • Zhengzhou, Henan, China
      • Zhengzhou, Henan, China
        • Recruiting
        • People's Hospital of Zhengzhou
        • Contact:
          • Shuling Zhang, Doctor
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
      • Wuhan, Hubei, China
        • Recruiting
        • People's Hospital Affiliated Hubei Medical University
        • Contact:
    • Hunan
      • Wuhan, Hunan, China
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
      • Wuhan, Hunan, China
      • Wuhan, Hunan, China
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
    • Jiangsu
      • Nantong, Jiangsu, China
        • Recruiting
        • Nantong University Affiliated Hospital
        • Contact:
      • Subei, Jiangsu, China
        • Recruiting
        • Subei People's Hospital of Jiangsu
        • Contact:
      • Xuzhou, Jiangsu, China
        • Recruiting
        • Mineral General Hospital, Xuzhou
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • JiangXi Provincial People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
      • Changchun, Jilin, China
        • Recruiting
        • China-japan Friendship Hospital of Jilin University
        • Contact:
    • Liaoning
      • Anshan, Liaoning, China
        • Recruiting
        • Changda Hospital, Anshan
        • Contact:
      • Dalian, Liaoning, China
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
      • Dalian, Liaoning, China
        • Recruiting
        • Affiliated Zhongshan Hospital of Dalian University
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • First Hospital of China Medical University
        • Contact:
    • Nei Monggol
      • Baotou, Nei Monggol, China
        • Recruiting
        • Baotou Central Hospital
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
      • Yinchuan, Ningxia, China
        • Recruiting
        • The People's Hospital of Ningxia
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
      • Jining, Shandong, China
      • Qingdao, Shandong, China
        • Recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
      • Qingdao, Shandong, China
        • Recruiting
        • QingDao Municipal Hospital
        • Contact:
      • Qingdao, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University (Qingdao)
        • Contact:
      • Tai'an, Shandong, China
        • Recruiting
        • The 88th Hospital of PLA
        • Contact:
    • Shanghai
      • Huangpu, Shanghai, China
        • Recruiting
        • Shanghai Changzheng Hospital
        • Contact:
      • Luwan, Shanghai, China
      • Putong, Shanghai, China
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • The First Affiliated Hospital of Shanxi Medical University
        • Contact:
      • Xi'an, Shanxi, China
        • Recruiting
        • First Affiliated Hospital Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shanxi, China
    • Sichuan
      • Nanchong, Sichuan, China
        • Recruiting
        • Affiliated Hospital of North Sichuan Medical College
        • Contact:
      • Zigong, Sichuan, China
        • Recruiting
        • ZiGong First People's Hospital
        • Contact:
    • Tianjin
      • Heping, Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
      • Jinnan, Tianjin, China
        • Recruiting
        • Tianjin Huanhu Hospital
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Recruiting
        • Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Provincial people's hospital
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Zhejiang University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Shao Yifu Hospital of Zhejiang Medical University
        • Contact:
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo City Medical Treatment Center Lihuili Hospital
        • Contact:
      • Wenzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Wenzhou Medical Univeristy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with family histroy of Alzheimer's disease, characterised with at least two first-degree relatives.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Familial Alzheimer's disease group
Familial Alzheimer's disease with the known mutation presenilin1 (PSEN1), presenilin2 (PSEN2) and amyloid precursor protein (APP) including mutation carriers and noncarriers, presymptomatic and symptomatic.
Normal control group
Normal cognitive control people

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of gene mutations in familial Alzheimer's disease in China.
Time Frame: 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.
An Average of 1 year
The development patterns of genetic, biofluid, imaging, and neuropsychological markers of FAD.
Time Frame: 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.
An Average of 3 to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of neuropsychological function in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China.
Time Frame: An Average of 1 year
Changes of neuropsychological function measured by neuropsychological assessment battery.
An Average of 1 year
Changes of brain structure in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China.
Time Frame: An Average of 1 year
Changes of structure of the whole brain, hippocampus other brain structures measured by MRI.
An Average of 1 year
Changes of brain glucose metabolism in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China.
Time Frame: 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).
An Average of 1 year
Changes of brain amyloid deposition in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China.
Time Frame: An Average of 1 year
Changes of amyloid deposition of the whole brain, hippocampus and other brain structures as measured by amyloid PET.
An Average of 1 year
Changes of brain tau deposition in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China.
Time Frame: An Average of 1 year
Changes of tau deposition of the whole brain, hippocampus and other brain structures as measured by tau PET.
An Average of 1 year
Changes of humoral biomarkers in pedigree members at different stage of cognitive impairment in familial Alzheimer's disease in China.
Time Frame: 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.
Each biomarker with time frame of average 1 year
The effective non-pharmacologic treatment(NPT) intervention
Time Frame: 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.
An Average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Collaborators

Peking University First Hospital
The First Affiliated Hospital of Anhui Medical University
Xiangya Hospital of Central South University
Peking Union Medical College Hospital
Beijing Tiantan Hospital
Chinese PLA General Hospital
Peking University Third Hospital
RenJi Hospital
Tongji Hospital
Qilu Hospital of Shandong University
Guangzhou Psychiatric Hospital
Hebei General Hospital
First Affiliated Hospital Xi'an Jiaotong University
The Affiliated Hospital of Qingdao University
Ningbo Medical Center Lihuili Hospital
Ruijin Hospital
First Affiliated Hospital of Zhejiang University
Shandong Provincial Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Beijing Chao Yang Hospital
Qingdao Municipal Hospital
The Third Xiangya Hospital of Central South University
China-Japan Friendship Hospital
The First Hospital of Jilin University
Henan Provincial People's Hospital
Fu Xing Hospital, Capital Medical University
Tianjin Medical University General Hospital
Fujian Medical University Union Hospital
The Second Affiliated Hospital of Chongqing Medical University
The Affiliated Hospital Of Guizhou Medical University
Tang-Du Hospital
First Hospital of China Medical University
General Hospital of Ningxia Medical University
Zhejiang Provincial People's Hospital
First Affiliated Hospital of Wenzhou Medical University
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
The First Affiliated Hospital of Shanxi Medical University
Shanghai Changzheng Hospital
First Hospital of Shijiazhuang City
China-Japan Union Hospital, Jilin University
The First Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Harbin Medical University
The People's Hospital of Ningxia
The Affiliated Zhongshan Hospital of Dalian University
First Affiliated Hospital of Guangxi Medical University
Jiangxi Provincial People's Hopital
Affiliated Hospital of North Sichuan Medical College
Dongfang Hospital Beijing University of Chinese Medicine
Baotou Central Hospital
Beijing Geriatric Hospital
Kaifeng Central Hospital
Tianjin Huanhu Hospital
Qilu Hospital of Shandong University (Qingdao)
Handan Central Hospital
Tangshan Worker's Hospital
People's Hospital of Zhengzhou University
Wuhan University Zhongnan Hospital
People's Hospital Affiliated Hubei Medical University
Subei People's Hospital of Jiangsu
Nantong University Affiliated Hospital
Mineral General Hospital, Xuzhou
Anshan Central Hospital
The 960th Hospital of PLA
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
Shao Yifu Hospital of Zhejiang Medical University
People's Hospital of Chongqing
Zigong No.1 Peoples Hospital

Investigators

  • Study Chair: Jianping Jia, Doctor, Xuanwu Hospital of Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2005

Primary Completion (Estimated)

January 1, 2038

Study Completion (Estimated)

January 1, 2038

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

September 1, 2018

First Posted (Actual)

September 5, 2018

Study Record Updates

Last Update Posted (Actual)

November 2, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYXWJ002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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