Status:
RECRUITING
Study on Neuropsychiatric Behavior in Cadmium-exposed People
Lead Sponsor:
Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
Conditions:
Cadmium Exceeds the Standard
Eligibility:
All Genders
18+ years
Brief Summary
This study hypothesized that excessive cadmium is related to clinical pain, depression, and cognitive impairment, and that related indicators will improve after cadmium is eliminated.
Detailed Description
This study will combine the research progress of the innovative drug GMDTC, the mechanism of nerve damage caused by Cd2+ disrupting Ca2+ homeostasis, imaging technology and analysis methods, and the b...
Eligibility Criteria
Inclusion
- 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
- 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))
Key Trial Info
Start Date :
January 8 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06572566
Start Date
January 8 2024
End Date
December 30 2025
Last Update
February 20 2025
Active Locations (1)
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1
Hunan Occupational Disease Prevention and Control Institute
Changsha, Hunan, China, 410000