Study on Neuropsychiatric Behavior in Cadmium-exposed People
- Conditions
- Cadmium Exceeds the Standard
- Interventions
- Other: Non-invasive examination and assessment.
- Registration Number
- NCT06572566
- Lead Sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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.
- 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))
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cadmium exceeding standard group Non-invasive examination and assessment. The urine cadmium level exceeding 5 μg/g creatinine for two consecutive times. healthy control group Non-invasive examination and assessment. Urine cadmium ≤ 5 μg/g creatinine.
- Primary Outcome Measures
Name Time Method Cadmium load Baseline, after 2 weeks, after 6 weeks To comprehensively assess the urinary cadmium levels in volunteers, blood cadmium and urinary cadmium levels were measured at different time points.
The Hamilton Depression Rating Scale (HAMD) Baseline, after 2 weeks, after 6 weeks mental and psychological status was assessed with the Hamilton Depression Rating Scale (HAMD).The scale will include the unabbreviated scale title, the minimum and maximum values, and higher scores mean a worse outcome.
McGill Pain Questionnaire Short Form (MPQ) Baseline, after 2 weeks, after 6 weeks Pain was measured through the McGill Pain Questionnaire Short Form (MPQ)，The scale will include the unabbreviated scale title, the minimum and maximum values, and higher scores mean a worse outcome.
MATRICS Consensus Cognitive Battery (MCCB) Baseline, after 2 weeks, after 6 weeks The internationally recognized MATRICS Consensus Cognitive Battery (MCCB) for objective assessment of cognitive function.Cognitive scores for all individuals will be calculated using the MCCB software, yielding corrected scores for each test as well as an overall cognitive score.
- Secondary Outcome Measures
Name Time Method Hamilton Anxiety Scale（HAMA） Baseline, after 2 weeks, after 6 weeks The HAMA scale will be used to assess the anxiety levels of volunteers, with higher scores indicating more severe anxiety.
One of the early indicators of kidney injury--β2-MG Baseline, after 2 weeks, after 6 weeks β2-microglobulin(β2-MG).Clinically, the measurement of β2-MG concentration in urine provides an early, reliable, and sensitive indicator for assessing renal function and diagnosing cadmium toxicity.
One of the early indicators of kidney injury--NAG Baseline, after 2 weeks, after 6 weeks N-acetyl-β-D-glucosaminidase,NAG. Urinary N-acetyl-beta-D-glucosaminidase (NAG) activity is one of the sensitive and specific indicators for renal tubular lesions and can serve as an early diagnostic marker for tubular damage, even providing earlier predictive value than urinary albumin.
Trial Locations
- Locations (1)
Hunan Occupational Disease Prevention and Control Institute
🇨🇳Changsha, Hunan, China