Establishing a cohort for Alzheimer's disease research in China
Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging
This study is trying to understand how brain scans and other health markers relate to Alzheimer's disease in both people with and without cognitive issues in China, to help find ways to detect and prevent the disease early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 45 Years to 90 Years |
| Sex | All |
| Sponsor | Huashan Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06827678 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 45 to 90 years, both cognitively unimpaired and impaired, with no significant neurological or chronic illnesses.
Not a fit: Patients with a family history of Alzheimer's disease or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and prevention strategies for Alzheimer's disease.
How similar studies have performed: Other studies focusing on neuroimaging and biomarkers in Alzheimer's disease have shown promise, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.