China HEAD: a large community study on healthy aging and dementia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The China HEAD study is a large, prospective, community-based cohort enrolling about 20,000 adults aged 50–79 across multiple regions in China. It collects detailed clinical data, cognitive assessments, physical measurements, biospecimens, and, when feasible, electrophysiology and imaging data to explore early signs of cognitive decline and ADRD. Participants are followed annually for up to 50 years to observe progression from normal cognition to MCI and dementia. The study has a biobank and multi-omics component to support future research and potential intervention studies. Ethical approval was obtained, and informed consent is collected at baseline.

Why it matters

Who can join: the full rules

Inclusion Criteria:

China HEAD Community Cohort:

1. Resident in a Chinese community.
2. Aged 50-79 years.
3. Have adequate vision and hearing (with glasses or hearing aids if necessary), and be able to walk, communicate, and complete study-related assessments (including questionnaires, physical examinations, neuropsychological assessments, and biospecimen collection) independently or with assistance.
4. Willing to provide written informed consent for baseline assessments, follow-up, biospecimen donation, and data collection.

China HEAD Familial Sub-cohort:

1. Resident in a Chinese community.
2. Aged 18 years or older.
3. Have a family history of Alzheimer's disease (AD) involving at least two first-degree relatives across at least two consecutive generations, with AD diagnoses previously established at tertiary hospitals and verified through medical history.
4. Meet the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria for AD.
5. Have adequate vision and hearing (with glasses or hearing aids if necessary), and be able to walk, communicate, and complete study-related assessments (including questionnaires, physical examinations, neuropsychological assessments, and biospecimen collection) independently or with assistance.
6. Willing to provide written informed consent for baseline assessments, follow-up, biospecimen donation, and data collection.

Exclusion Criteria:

The following exclusion criteria apply to participants in the HEAD study:

1. Refusal to provide written informed consent.
2. Refusal to participate in questionnaires or other data collection procedures.
3. Refusal to provide blood or other biological samples.
4. Self-reported stroke events (e.g., cerebral hemorrhage or cerebral infarction) within the past six months.
5. Self-reported diseases potentially impairing cognition, including congenital intellectual disability, intracranial tumors, epilepsy, Parkinson's disease, or severe psychiatric disorders such as schizophrenia requiring medication.
6. Self-reported major organ failure (e.g., liver or kidney failure), malignancy, or other conditions associated with a shortened life expectancy that prevent completion of follow-up assessments.

Additional exclusion criteria for participants undergoing magnetic resonance imaging (MRI):

1\. Inability to tolerate MRI examinations or contraindications to MRI, including claustrophobia; MRI-incompatible implanted pacemakers, aneurysm clips, artificial heart valves, cochlear implants, or other metallic implants; or other clinical conditions or examination findings that investigators consider potentially harmful during MRI.

Where it's running

• Beijing Normal University
  Beijing, China Recruiting
• Beijing Tiantan Hospital, Capital Medical University
  Beijing, China Recruiting
• Beijing University of Posts and Telecommunications
  Beijing, China Recruiting
• Chinese PLA General Hospital
  Beijing, China Recruiting
• Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
  Beijing, China Recruiting
• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jin-Tai Yu, MD, PhD
• Email: jintai_yu@fudan.edu.cn
• Phone: +86 18678999982

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.