Alzheimer's Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participate in this trial and sign the informed consent form; 2. Age >=18 years old and <=95 years old (subject to the date of signing the informed consent form), gender is not limited; 3.AD patient meets the 2023 NIA-AA guidelines for diagnostic criteria for AD; 4. Whether the subject was diagnosed as an AD patient by a neurologist after receiving ATN PET scintigraphy; 5. Female subjects of childbearing potential, male subjects and partners of male subjects agree to use reliable contraception within 1 month after the end of the last study drug infusion; 6. Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other test procedures.
Exclusion criteria
Exclusion criteria: 1. Patients with neurological, psychiatric or cerebral parenchymal diseases (such as stroke, epilepsy, tumor, trauma, etc.); 2. Long-term alcohol abuse or long-term use of drugs that cause cognitive dysfunction; 3. Patients with severe endocrine, cardiovascular, digestive, urinary and other systemic diseases; 4. Inability to complete clinical physical examination, cognitive assessment, and image scan for any reason; 5. Those with Hachinski ischemia index =4 points or MRI T2WI or FLAIR sequence white matter hyperintense Fazekas score >=2 points; 6. Have previously used radionuclides and have less than 10 physical half-lives since the time of administration of this study; 7. Is conducting or plans to participate in any drug or device clinical trial during the study period; 8. Known allergy to injection or its excipients; 9. Subjects have abnormalities in physical examination, ECG and clinical laboratory tests during the screening period, which may affect safety or compliance as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic results; | — |
Countries
China
Contacts
The First Affiliated Hospital of Nanchang University