Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2025-12-27 @ 1:59 PM
Study NCT ID:
NCT06572566
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Neuropsychiatric Behavior in Cadmium-exposed People
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'targetDuration': '4 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-25', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cadmium load', 'timeFrame': 'Baseline, after 2 weeks, after 6 weeks', 'description': 'To comprehensively assess the urinary cadmium levels in volunteers, blood cadmium and urinary cadmium levels were measured at different time points.'}, {'measure': 'McGill Pain Questionnaire Short Form (MPQ)', 'timeFrame': 'Baseline, after 2 weeks, after 6 weeks', 'description': '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.'}, {'measure': 'MATRICS Consensus Cognitive Battery (MCCB)', 'timeFrame': 'Baseline, after 2 weeks, after 6 weeks', 'description': '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.'}, {'measure': 'The Hamilton Depression Rating Scale (HAMD)', 'timeFrame': 'Baseline, after 2 weeks, after 6 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'One of the early indicators of kidney injury--β2-MG', 'timeFrame': 'Baseline, after 2 weeks, after 6 weeks', 'description': '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.'}, {'measure': 'Hamilton Anxiety Scale（HAMA）', 'timeFrame': 'Baseline, after 2 weeks, after 6 weeks', 'description': 'The HAMA scale will be used to assess the anxiety levels of volunteers, with higher scores indicating more severe anxiety.'}, {'measure': 'One of the early indicators of kidney injury--NAG', 'timeFrame': 'Baseline, after 2 weeks, after 6 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cadmium', 'Cadmium exceeds the standard', 'neuropsychiatric behavior', 'neuroimaging', 'cognitive impairment'], 'conditions': ['Cadmium Exceeds the Standard']}, 'referencesModule': {'references': [{'pmid': '22981394', 'type': 'BACKGROUND', 'citation': 'Clemens S, Aarts MG, Thomine S, Verbruggen N. Plant science: the key to preventing slow cadmium poisoning. Trends Plant Sci. 2013 Feb;18(2):92-9. doi: 10.1016/j.tplants.2012.08.003. Epub 2012 Sep 12.'}, {'pmid': '24847886', 'type': 'BACKGROUND', '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.'}, {'pmid': '23968694', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old, both men and women are welcome\n* 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\n* Urinary cadmium \\>5 μmol/mol creatinine for 2 consecutive days (creatinine content is ≥0.3 μg/L and ≤3 μg/L)\n* Right-handed\n* Voluntarily participate in this study and sign informed consent.\n\nExclusion Criteria:\n\n* 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 )\n* 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\n* 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)\n* Have contraindications for MRI or bone density examination (pacemaker or defibrillator, artificial heart valve, clothing containing fluorescein, iron, etc.)\n* Pregnant and lactating women\n* Those who cannot tolerate venipuncture and/or have a history of fainting from blood or needles\n* 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))'}, 'identificationModule': {'nctId': 'NCT06572566', 'briefTitle': 'Study on Neuropsychiatric Behavior in Cadmium-exposed People', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.'}, 'officialTitle': 'Study on the Mechanism of Action of Chemical Category 1 Innovative Drug GMDTC on Neuropsychiatric Behavior in Cadmium-exposed People', 'orgStudyIdInfo': {'id': 'JianerShengPharmaNI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cadmium exceeding standard group', 'description': 'The urine cadmium level exceeding 5 μg/g creatinine for two consecutive times.', 'interventionNames': ['Other: Non-invasive examination and assessment.']}, {'label': 'healthy control group', 'description': 'Urine cadmium ≤ 5 μg/g creatinine.', 'interventionNames': ['Other: Non-invasive examination and assessment.']}], 'interventions': [{'name': 'Non-invasive examination and assessment.', 'type': 'OTHER', 'description': '1\\) Test the blood and urine components of all subjects to evaluate the damage to kidney function caused by excessive cadmium. 2) Conduct MRI examinations on all subjects to evaluate changes in brain functional connectivity, metabolism, and structure after excessive cadmium exposure. 3) Conduct bone density examinations on all subjects to evaluate changes in bone density after excessive cadmium exposure. (3) Clinical psychiatric assessment: All subjects will be assessed on their mental and psychological conditions such as pain, cognitive function, depression, anxiety, mania, sleep quality, and suicide risk.', 'armGroupLabels': ['Cadmium exceeding standard group', 'healthy control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Pei, PhD-c', 'role': 'CONTACT', 'email': '1047977225@qq.com', 'phone': '86+15377490030'}, {'name': 'Xiaobi Deng', 'role': 'CONTACT', 'email': 'xdyyyjk@163.com', 'phone': '86+13787242979'}, {'name': 'Fang Pei, PhD-c', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hunan Occupational Disease Prevention and Control Institute', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Xiaojiang Tang, PhD', 'role': 'CONTACT', 'email': 'river-t@126.com', 'phone': '13719282259'}, {'name': 'Rong Ma', 'role': 'CONTACT', 'email': 'gynkmarong@163.com', 'phone': '17685224168'}], 'overallOfficials': [{'name': 'Fang Pei', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hunan Occupational Disease Prevention and Control Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}