The Chinese Familial Alzheimer's Network
A Multi-center Longitudinal Cohort Study of Familial Alzheimer's Disease in China
Capital Medical University
40,000 participants
Jan 10, 2005
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria13
- Familial Alzheimer's disease group
- 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.
- 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 Criteria17
- 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；
- Normal control group
- 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.
Locations(65)
View Full Details on ClinicalTrials.gov
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NCT03657732