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Establishing a network for Familial Alzheimer's Disease in China

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

Observational Capital Medical University · NCT03657732

This study is trying to build a network in China to better understand Familial Alzheimer's Disease by collecting information about families, genetics, and the disease's progression.

Quick facts

Study typeObservational
Enrollment40000 (estimated)
Ages18 Years and up
SexAll
SponsorCapital Medical University Academic / other
Locations65 sites (Hefei, Anhui and 64 other locations)
Trial IDNCT03657732 on ClinicalTrials.gov

What this trial studies

This research aims to create and enhance a nationwide network focused on Familial Alzheimer's Disease (FAD) in China. By gathering extensive data on family demographics, genetics, neuropsychology, neuroimaging, and biomarkers, the study seeks to clarify the genetic and clinical characteristics of FAD. It will also investigate the epidemiology of the disease across different demographics and regions in China. The project will involve regular follow-ups and sample collections to monitor disease progression and identify potential early diagnostic biomarkers.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals from families with a history of Alzheimer's Disease, specifically those with at least two first-degree relatives affected by the condition.

Not a fit: Patients without a familial history of Alzheimer's Disease or those who are bedridden may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved clinical diagnosis and treatment options for patients with Familial Alzheimer's Disease.

How similar studies have performed: Other studies focusing on familial Alzheimer's Disease have shown promise, but this specific approach in the Chinese population is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Hefei, Anhui and 64 other locations

+15 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer DiseaseFamilial Alzheimer DiseaseAlzheimer's Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.