Study on the Mechanism of Action of Chemical Category 1 Innovative Drug GMDTC on Neuropsychiatric Behavior in Cadmium-exposed People
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cadmium load
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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))
研究组 & 干预措施
healthy control group
Urine cadmium ≤ 5 μg/g creatinine.
干预措施: Non-invasive examination and assessment. (Other)
Cadmium exceeding standard group
The urine cadmium level exceeding 5 μg/g creatinine for two consecutive times.
干预措施: Non-invasive examination and assessment. (Other)
结局指标
主要结局
Cadmium load
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Hamilton Anxiety Scale（HAMA）(Baseline, after 2 weeks, after 6 weeks)
- One of the early indicators of kidney injury--β2-MG(Baseline, after 2 weeks, after 6 weeks)
- One of the early indicators of kidney injury--NAG(Baseline, after 2 weeks, after 6 weeks)