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:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT06572566
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years old, both men and women are welcome
* The weight of male subjects is ≥50.0 kg, the weight of female subjects is ≥45.0 kg, and the body mass index (BMI) is between 19 \~ 26 kg/m2, including the critical value
* Urinary cadmium \>5 μmol/mol creatinine for 2 consecutive days (creatinine content is ≥0.3 μg/L and ≤3 μg/L)
* Right-handed
* Voluntarily participate in this study and sign informed consent.
Exclusion Criteria:
* Combined with other neurodevelopmental problems (such as autism), organic brain mental disorders (such as Alzheimer\'s disease, Parkinson\'s disease, etc.) and organic brain diseases (such as cerebral hemorrhage, infarction, etc.) that meet the DSM-5 diagnostic criteria )
* Those who have suffered from or are currently suffering from any serious clinical diseases that pose safety risks such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities
* Continuous use of high-dose neuroleptics in the past 3 months (high-dose: daily dosage of benzodiazepines ≥ 4 mg lorazepam equivalent; long-term: the total duration of use is at least 60 days)
* Have contraindications for MRI or bone density examination (pacemaker or defibrillator, artificial heart valve, clothing containing fluorescein, iron, etc.)
* Pregnant and lactating women
* Those who cannot tolerate venipuncture and/or have a history of fainting from blood or needles
* Those with eGFR \<30 mL/min/1.73 m2 during screening (eGFR is calculated using the Cockcroft-Gault formula: eGFR(mL/min/1.73m2) = (140-age)\*weight (kg)/\[0.818\*Cr(μmol/L )\]\*0.85(female))
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06572566
Study Brief:
Protocol Section:
NCT06572566