Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05697588
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-27
First Post:
2022-09-01
Brief Title:
Exploring the Predicting Biomarkers From Mild Cognitive Impairment to Dementia EBMID
Sponsor:
weicuibai
Organization:
Xuanwu Hospital Beijing
Study Overview
Official Title:
Studies on Biomarkers for Mild Cognitive Impairment Conversion to Dementia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
Mild cognitive impairment MCI represents a transitional stage between healthy aging and dementia and affects more than 15 of the population over the age of 60 in China About 15 patients with MCI could progress into dementia after two years and about one-third develop into dementia within five years which will lead to suffering as well as staggering economic and care burden So exploring the predicting biomarkers from MCI to dementia to identify and delay progression to dementia at an early stage is of great social and clinical significance Some reports based on a single neural biomarker suggest that risk models can predict the conversion of MCI to dementia but no widely recognized prediction models basing on multiple complex markers have been used in clinical practice The objectives of this study are to outline the spectrum of MCI transforming into dementia through a 5-year prospective longitudinal cohort study Secondly screening biomarkers for MCI transmit to dementia are based on clinical symptoms neuropsychology neuroimaging neuroelectrophysiology and humoral markers tests data
Detailed Description:
The 900 patients with MCI 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 for 5 years According to the neuropsychological evaluation results of follow-up the subjects were divided into MCI progression MCI-P and MCI stabilization MCI-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 MCI 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 MCI conversion to dementia in the blood cerebrospinal fluid urine saliva and feces Using statistic and machine learning methods the biomarkers and their combinations from MCI transmit to dementia could be obtained and it can contribute to the construction of a risk prediction model and early warning evaluation system of MCI transmit to dementia
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