Ignite Creation Date:
2024-05-06 @ 5:49 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05446701
Status:
UNKNOWN
Last Update Posted:
2022-07-07
First Post:
2022-04-09
Brief Title:
Assessment of Serum FAM19A5 Level in Egyptian Patients With Neuromyelitis Optica Spectrum Disorder
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Assessment of Serum FAM19A5 Level in Egyptian Patients With Neuromyelitis Optica Spectrum Disorder
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
NOT_YET_RECRUITING
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:
Neuromyelitis optica spectrum disorders NMOSD are severe inflammatory autoimmune conditions of the central nervous system CNS The discovery of NMOSD-specific aquaporin 4 AQP4 antibody has established that NMOSD is indeed a distinct entity Approximately 80 of patients with NMOSD test positive for aquaporin-4 AQP4 immunoglobulin G IgG antibodies AQP4-IgG associated NMOSD appears to target astrocytes not myelin leading to elevated markers of astrocyte injury during attacks Untill now there is limited research about understanding the biomarkers of astrocyte injury and the following reactive gliosis Family with sequence similarity 19-memberA5 FAM19A5 protein is postulated to regulate nervous and immune cells of the brain as a brain-specific chemokine but its precise functional role is not well understood A recent study suggested that FAM19A5 is secreted by reactive astrocytes following CNS damage and triggers reactive gliosis In another recent study serum FAM19A5 was higher in patients with NMOSD-AQP4 than in other CNS demyelinating diseases and healthy controls So we need to study the level of this novel biomarker among our Egyptian NMOSD patients and whether it shall be a new biomarker for NMOSD
Moreover just few studies conducted on cognitive dysfunctions in NMOSD patients and they demonstrate a significant decrease of cognitive abilities and the prevalence of CI in different samples varies between 30 and 70 So further studies are needed to investigate the cognitive performance in NMOSD patients
Moreover just few studies conducted on cognitive dysfunctions in NMOSD patients and they demonstrate a significant decrease of cognitive abilities and the prevalence of CI in different samples varies between 30 and 70 So further studies are needed to investigate the cognitive performance in NMOSD patients
Detailed Description:
Sixty patients diagnosed as NMOSD based on the recently revised 2015 international consensus diagnostic criteria for NMOSD attending Neurology clinic Asyut University hospitals Asyut university and Kasr Al-Ainy multiple sclerosisneuroimmunology clinic Cairo University hospitals Cairo University Egypt through one and half year from study onset Sixty healthy volunteers without any neurological or systemic medical diseases age and sex matched will be enrolled as healthy controlsHCs
Aim of the work
1 Determining the serum level of FAM19A5 in a cohort of Egyptian patients with NMOSD in comparison with healthy controls and its relationship with the different clinical phenotypes and parameters and disease severity of NMOSD patients
2 Cognitive performance of NMOSD patients in comparison with healthy controls
Aim of the work
1 Determining the serum level of FAM19A5 in a cohort of Egyptian patients with NMOSD in comparison with healthy controls and its relationship with the different clinical phenotypes and parameters and disease severity of NMOSD patients
2 Cognitive performance of NMOSD patients in comparison with healthy controls
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