Establishing a cohort for Alzheimer's disease research in China

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

This observational study aims to investigate neuroimaging and biomarkers related to Alzheimer's disease (AD) within the Chinese population. It will recruit participants with both cognitive impairments and those who are cognitively unimpaired, utilizing a large array of PET imaging and multi-dimensional scales. The study seeks to explore the longitudinal changes in biomarkers and cognition, as well as the interactions between body and brain markers. By identifying risk factors associated with AD, the research aims to develop a comprehensive risk model for early detection and prevention, and to uncover new therapeutic targets.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cognitive unimpaired(CU) controls:

(1) Aged between 45 and 90 years; no gender restrictions； (2) Cognitive function is assessed as normal by the researcher based on cognitive tests, with a Clinical Dementia Rating (CDR) score of 0; (3) Confirmed by the researcher to have no neurological diseases, major chronic illnesses, malignant tumors, or acute infectious diseases; (4) No family history of Alzheimer's disease (AD) or other neurological diseases related to cognitive impairment and movement disorders; (5) Able to understand and provide written informed consent before any assessment; (6) Female subjects must provide medical documentation proving they have undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation) or have been menopausal for over one year. If they are still of childbearing potential, they must use effective contraceptive measures during the study; (7) Male subjects must use effective contraceptive measures during the study period and are prohibited from donating sperm during this time; (8) Willing and able to comply with all study procedures. 2. Cognitive impaired(CI) patients:

1. Aged between 45 and 90 years; no gender restrictions;
2. CDR score ≥ 0.5;
3. MMSE score ≤ 24;
4. Brain MRI findings support the diagnosis of AD, with no evidence of other neurological diseases;
5. Any medications taken to alleviate AD symptoms must be maintained at a stable dose for at least 30 days before study participation;
6. Written informed consent must be provided by the subject or their legal guardian/caregiver;
7. If necessary, subjects may be accompanied by a caregiver;
8. Before any assessment, the subject or their legal representative must understand and sign a written informed consent form;
9. Female subjects must provide medical documentation confirming surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, or tubal ligation).

Exclusion Criteria:

* All subjects:

  1. Presence of severe neurological diseases or serious disorders affecting the gastrointestinal, cardiovascular, hepatic, renal, hematologic, oncologic, endocrine, respiratory, or immune systems;
  2. Presence of MRI-incompatible metal implants, including cardiac pacemakers, intravascular metal devices, insulin pumps, cochlear implants, nerve stimulators, or cerebral aneurysm clips;
  3. Inability to tolerate MRI noise or a history of claustrophobia;
  4. Exposure to ionizing radiation exceeding 50 mSv within the past year due to participation in other clinical or scientific research;
  5. History of drug or alcohol abuse;
  6. Pregnancy or lactation;
  7. Poor venous access, making repeated venipuncture infeasible;
  8. Use of experimental drugs or devices with unknown efficacy or safety within the past month;
  9. Allergy to any components of the tracer injection;
  10. Any condition that, in the investigator's judgment, may pose a risk or compromise the integrity of the study.

Where it's running

• Huashan Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Fang Xie, PhD — Huashan Hospital
• Study coordinator: Yihui Guan, MD
• Email: guanyihui@hotmail.com
• Phone: +8613764308300

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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.