Establishment of the Chinese Preclinical Alzheimer's Disease Study With Multiple Neuroimaging

Launched by HUASHAN HOSPITAL · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial aims to better understand Alzheimer’s disease (AD) in the Chinese population by studying brain images and other biological markers. Researchers want to track how AD progresses over time, see how different markers in the body and brain interact, and possibly identify new ways to detect the disease earlier.

To participate, individuals must be between 45 and 90 years old and can be either healthy or have early signs of cognitive impairment. Healthy participants should have normal cognitive function, while those with cognitive impairment must have a confirmed diagnosis of Alzheimer’s disease. Participants will undergo brain imaging and other assessments over time, contributing to vital research that could improve the understanding and treatment of Alzheimer’s disease. It’s important to note that individuals with certain medical conditions or those who have had recent exposure to radiation may not be eligible.

Gender

ALL

Eligibility 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.