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The Chinese Familial Alzheimer's Network (CFAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03657732
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : June 1, 2022
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Fu Xing Hospital, Capital Medical University
Peking Union Medical College Hospital
Peking University First Hospital
Peking University Third Hospital
Chinese PLA General Hospital
China-Japan Friendship Hospital
Beijing Geriatric Hospital
The First Affiliated Hospital of Dalian Medical University
Fujian Medical University Union Hospital
Guangzhou Psychiatric Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Guangxi Medical University
The Affiliated Hospital Of Guizhou Medical University
Handan Central Hospital
Hebei General Hospital
First Hospital of Shijiazhuang City
Tangshan Worker's Hospital
Henan Provincial People's Hospital
Kaifeng Central Hospital
People's Hospital of Zhengzhou University
First Affiliated Hospital of Harbin Medical University
Tongji Hospital
People's Hospital Affiliated Hubei Medical University
Wuhan University Zhongnan Hospital
The Third Xiangya Hospital of Central South University
Xiangya Hospital of Central South University
The First Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Subei People's Hospital of Jiangsu
Nantong University Affiliated Hospital
Mineral General Hospital, Xuzhou
Jiangxi Provincial People's Hopital
Anshan Central Hospital
The Affiliated Zhongshan Hospital of Dalian University
First Hospital of China Medical University
Baotou Central Hospital
General Hospital of Ningxia Medical University
The People's Hospital of Ningxia
The Affiliated Hospital of Qingdao University
The 960th Hospital of PLA
Qilu Hospital of Shandong University
Qilu Hospital of Shandong University (Qingdao)
Shandong Provincial Hospital
Qingdao Municipal Hospital
The First Affiliated Hospital of Shanxi Medical University
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
RenJi Hospital
Shanghai Changzheng Hospital
Affiliated Hospital of North Sichuan Medical College
Tianjin Huanhu Hospital
Tianjin Medical University General Hospital
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Zhejiang University
Shao Yifu Hospital of Zhejiang Medical University
Zhejiang Provincial People's Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
The Second Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Anhui Medical University
People's Hospital of Chongqing
Dongfang Hospital Beijing University of Chinese Medicine
Zigong First People's Hospital
Information provided by (Responsible Party):
Jianping Jia, Capital Medical University

Study Description
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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.

Condition or disease
Alzheimer Disease Familial Alzheimer Disease (FAD)

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 40000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Years
Official Title: A Multi-center Longitudinal Cohort Study of Familial Alzheimer's Disease in China
Actual Study Start Date : January 10, 2005
Estimated Primary Completion Date : January 1, 2038
Estimated Study Completion Date : January 1, 2038

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Biospecimen Retention:   Samples With DNA
Blood, cerebral spinal fluid, saliva, and urine

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657732


Contacts
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Contact: Jianping Jia, Doctor ＋8610-83199449 jiajp@vip.126.com

Locations
Show Show 65 study locations
Sponsors and Collaborators
Capital Medical University
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Fu Xing Hospital, Capital Medical University
Peking Union Medical College Hospital
Peking University First Hospital
Peking University Third Hospital
Chinese PLA General Hospital
China-Japan Friendship Hospital
Beijing Geriatric Hospital
The First Affiliated Hospital of Dalian Medical University
Fujian Medical University Union Hospital
Guangzhou Psychiatric Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First Affiliated Hospital of Guangxi Medical University
The Affiliated Hospital Of Guizhou Medical University
Handan Central Hospital
Hebei General Hospital
First Hospital of Shijiazhuang City
Tangshan Worker's Hospital
Henan Provincial People's Hospital
Kaifeng Central Hospital
People's Hospital of Zhengzhou University
First Affiliated Hospital of Harbin Medical University
Tongji Hospital
People's Hospital Affiliated Hubei Medical University
Wuhan University Zhongnan Hospital
The Third Xiangya Hospital of Central South University
Xiangya Hospital of Central South University
The First Hospital of Jilin University
China-Japan Union Hospital, Jilin University
Subei People's Hospital of Jiangsu
Nantong University Affiliated Hospital
Mineral General Hospital, Xuzhou
Jiangxi Provincial People's Hopital
Anshan Central Hospital
The Affiliated Zhongshan Hospital of Dalian University
First Hospital of China Medical University
Baotou Central Hospital
General Hospital of Ningxia Medical University
The People's Hospital of Ningxia
The Affiliated Hospital of Qingdao University
The 960th Hospital of PLA
Qilu Hospital of Shandong University
Qilu Hospital of Shandong University (Qingdao)
Shandong Provincial Hospital
Qingdao Municipal Hospital
The First Affiliated Hospital of Shanxi Medical University
Tang-Du Hospital
First Affiliated Hospital Xi'an Jiaotong University
Ruijin Hospital
RenJi Hospital
Shanghai Changzheng Hospital
Affiliated Hospital of North Sichuan Medical College
Tianjin Huanhu Hospital
Tianjin Medical University General Hospital
Traditional Chinese Medicine Hospital of Xinjiang Autonomous Region
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Wenzhou Medical University
First Affiliated Hospital of Zhejiang University
Shao Yifu Hospital of Zhejiang Medical University
Zhejiang Provincial People's Hospital
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
The Second Affiliated Hospital of Chongqing Medical University
The First Affiliated Hospital of Anhui Medical University
People's Hospital of Chongqing
Dongfang Hospital Beijing University of Chinese Medicine
Zigong First People's Hospital
Investigators
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Study Chair: Jianping Jia, Doctor Xuanwu Hospital of Capital Medical University
  Study Documents (Full-Text)

Documents provided by Jianping Jia, Capital Medical University:
Study Protocol  [PDF] June 30, 2020

More Information
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Additional Information:

Publications of Results:

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Responsible Party: Jianping Jia, Chief Director, Capital Medical University
ClinicalTrials.gov Identifier: NCT03657732    
Other Study ID Numbers: SYXWJ002
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jianping Jia, Capital Medical University:
Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders