Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT05372458
Eligibility Criteria:
Inclusion Criteria:
* Non-disease controls:
1. Age between 60 and 80 years old; gender is not limited.
2. The investigators have normal cognition and negative Aβ imaging through the test.
3. Informed consent must be signed in writing by the subjects or their legal guardians and caregivers.
4. Blood routine: white blood cell count (WBC) 4\~10×109/L; platelet (PLT) 100\~300×109/L; hemoglobin (HB) 120\~160 g/L; renal function: serum creatinine less than or equal to Upper limit of normal range; liver function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of normal range; electrocardiogram: no significant abnormality.
5. Willingness and ability to cooperate with all projects of this research.
AD patients/DM patients:
1. Age between 60 and 80 years old; gender is not limited.
2. The diagnosis of AD was based on the 2011 National Association on Aging and Alzheimer's Disease (NIA-AA) diagnostic criteria for possible AD dementia. The diagnostic criteria for diabetes were based on the 1999 World Health Organization (WHO) diagnostic criteria for diabetes.
3. Brain MRI supports the diagnosis of AD, and there is no evidence of other neurological diseases.
4. No neurological disease, major chronic disease, malignant tumor or acute infectious disease has been confirmed by the investigator.
5. An informed consent form must be signed in writing by the subjects or their legal guardians and caregivers.
6. Blood routine: white blood cell count (WBC) 4\~10×109/L; platelet (PLT) 100\~300×109/L; hemoglobin (HB) 120\~160 g/L; renal function: serum creatinine less than or equal to Upper limit of normal range; function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of normal range; electrocardiogram: no significant abnormality.
7. Willingness and ability to cooperate with all projects of this research.
Exclusion Criteria:
* Subjects meeting any of the following criteria will be excluded from the study:
1. Suffering from other serious neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor endocrine, respiratory system, immune deficiency and other serious diseases.
2. Candidate subjects have contraindications to PET/CT scanning. Those who cannot accept repeated intravenous injections; those who may be allergic to drugs and their components (including a history of severe allergy or allergic reactions, especially those who are allergic to the tested drugs); phobia of tightness.
3. In the past year, in addition to participating in the expected radiation exposure of this clinical study, have participated in other research programs or clinical care, resulting in radiation exposure exceeding the effective dose of 50 mSv.
4. Drug or alcohol abuse for at least 1 month.
5. The venous condition is poor and cannot tolerate repeated venipuncture.
6. The candidate subject has received major surgery within the past 3 months; received experimental drug or device treatment (with unclear effect or safety) within 1 month
7. The candidate subjects have any clinical conditions that the host of this study believes that this preparation may cause or have potential harm.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT05372458
Study Brief:
Protocol Section:
NCT05372458