Study on Neuropsychiatric Behavior in Cadmium-exposed People

Jianersheng (Zhuhai) Pharmaceutical Technology

Status

Enrolling

Conditions

Cadmium Exceeds the Standard

Treatments

Other: Non-invasive examination and assessment.

Study type

Observational

Funder types

Industry

Identifiers

NCT06572566

JianerShengPharmaNI

Details and patient eligibility

About

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.

Full 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 basis of our previous research work to explore the effect of the chemical Class 1 innovative drug GMDTC on the neuropsychiatric behavior of people with excessive cadmium. mechanism of action. This study is not limited to the study of the mechanism of neurotoxicity after Cd2+ deposition. It will also clarify the clinical efficacy of the innovative drug GMDTC in removing Cd2+ deposition in the brain and reducing damage, which is expected to open up new avenues for the treatment of cadmium neurotoxicity. 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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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))