Clinical trial NCT06572566: Study on Neuropsychiatric Behavior in Cadmium-exposed People
Official title: Study on the Mechanism of Action of Chemical Category 1 Innovative Drug GMDTC on Neuropsychiatric Behavior in Cadmium-exposed People
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cadmium Exceeds the Standard
Keywords: cadmium
Cadmium exceeds the standard
neuropsychiatric behavior
neuroimaging
cognitive impairment
Lead sponsor: Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects were recruited from the cadmium-excessive group at the Hunan Provincial Occupational Disease Prevention and Control Hospital from January 2024 to June 2024, and healthy volunteers were recruited from the outpatient clinic. It is planned to include 42 cases of people with excessive cadmium and 42 cases of healthy people.

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.

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 \&gt;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\&#39;s disease, Parkinson\&#39;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))

Primary outcomes:
measure: Cadmium load
timeFrame: Baseline, after 2 weeks, after 6 weeks
measure: McGill Pain Questionnaire Short Form (MPQ)
timeFrame: Baseline, after 2 weeks, after 6 weeks
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: Baseline, after 2 weeks, after 6 weeks
measure: The Hamilton Depression Rating Scale (HAMD)
timeFrame: Baseline, after 2 weeks, after 6 weeks
Secondary outcomes:
measure: One of the early indicators of kidney injury--β2-MG
timeFrame: Baseline, after 2 weeks, after 6 weeks
measure: Hamilton Anxiety Scale（HAMA）
timeFrame: Baseline, after 2 weeks, after 6 weeks
measure: One of the early indicators of kidney injury--NAG
timeFrame: Baseline, after 2 weeks, after 6 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Occupational Disease Prevention and Control Institute
state: Hunan
Study officials:
affiliation: Hunan Occupational Disease Prevention and Control Institute
name: Fang Pei
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Deng D, Xu C, Sun P, Wu J, Yan C, Hu M, Yan N. Crystal structure of the human glucose transporter GLUT1. Nature. 2014 Jun 5;510(7503):121-5. doi: 10.1038/nature13306. Epub 2014 May 18.
citation: Mergenthaler P, Lindauer U, Dienel GA, Meisel A. Sugar for the brain: the role of glucose in physiological and pathological brain function. Trends Neurosci. 2013 Oct;36(10):587-97. doi: 10.1016/j.tins.2013.07.001. Epub 2013 Aug 20.