Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419101
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-07
Brief Title:
Exploring the Diagnostic Biomarkers of Cognitive Disorders in China
Sponsor:
Cuibai WeiClinical Professor
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Cohort Study on Biomarkers of Cognitive Disorders in China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dementia is a syndrome characterized by progressive global cognitive impairment that impairs occupational family or social functioning It detrimentally affects personal health and quality of life imposing significant medical economy social and psychological burden on the countries and the patients family The internationally renowned dementia cohort includes the DIAN that focused on genetics studies the ADNI cohort featuring imaging and the FINGERS cohort focused on risk factor intervention etc Establishing standardized and shared longitudinal follow-up dementia cohorts and clinical database is an essential challenge for constructing dementia cohort in China Moreover there is a lack of large-scale prospective longitudinal follow-up cohorts within the Chinese population that cover subjective cognitive decline SCD to explore biomarkers with diagnostic and early warning value for different kinds of dementia and pre-dementia stages The study will rely on the dementia cohort based on Chinese population to explore the biological phenotype characteristics of the pre-dementia stage and different dementia subtypes and observe the dynamic change rules of the dementia cohort vertically so as to foster early intervention and improve prognosis for individuals with dementia
Detailed Description:
The 3000 patients with pre-dementia stage and different dementia subtypes will be enrolled in this study and data will be collected in the baseline including demographics clinical symptoms assessment of neuropsychology neuroimaging neuroelectrophysiology blood samples cerebrospinal fluid etc The changes of these data were dynamically observed through an annual follow-up According to the neuropsychological evaluation results of follow-up the subjects were divided into dementia progression dementia-P and dementia stabilization dementia-S Difference in clinical phenotype neuropsychology electrophysiology neuroimaging and body fluid multi-omics indicators between the two subtypes were compared and analyzed The neuropsychological testes in patients with dementia included some neuropsychological scales such as Clinical Dementia Rating CDR Mini-Mental State Examination MMSE Montreal Cognitive Assessment MoCA etc Multi-model neuroimaging evaluation screen the candidate neuroimaging markers including structure and functional brain magnetic resonance imaging MRI Diffusion tensor image DTI 18 F-2-fluro-D-deoxy-glucose-positron emission tomography 18F-FDG-PETAmyloid-PET and tau-PET To exploring neuroelectrophysiology biomarkers collect the data on polysomnography resting state electroencephalogram and evoked potentials P1 N1 P2 N2 etc ELISA SIMOA and other analytical methods were used to detect the contents related to dementia progression in the blood cerebrospinal fluid urine saliva and feces Multi-dimensional screening and identifying biomarkers of disease diagnosis and progression in all stages from subjective cognitive impairment to mild cognitive impairment to dementia in line with the characteristics of the Chinese population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None