Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179394
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-12-12
Brief Title:
Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities in Patients With Wilson Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
Primary objective
Collection of patients with wilson disease either presented with neurological or hepatic symptoms
Assessment of psychiatric and cognitive disorders in both groups by using specific scales Secondary objective
correlation of MRI brain findings with cognitive psychiatric symptoms found in the patients if possible
Collection of patients with wilson disease either presented with neurological or hepatic symptoms
Assessment of psychiatric and cognitive disorders in both groups by using specific scales Secondary objective
correlation of MRI brain findings with cognitive psychiatric symptoms found in the patients if possible
Detailed Description:
Wilsons disease is an autosomal recessive disorder of copper metabolism caused by ATP7B mutations Originally described as hepatolenticular degeneration it classically presents with the combination of liver disease and a movement disorder during adolescence or early adulthood albeit with a highly variable phenotype Up to 60 of patients have neurological or psychiatric symptoms at onset and are referred to as having neurological presentations 1 Chelating agents are used to de-copper patients but neurological outcomes are unpredictable symptoms usually improve however a minority have persistent or progressive neurological disability 2 3
It is clinically relevant that the severity of neurologic symptoms commonly fluctuates sometimes during the same day Symptoms may be exacerbated by stress concurrent illnesses or medications 4 WD has been associated with multiple cognitive emotional or psychiatric disorders which may occur at any stage of disease 5 The first psychiatric manifestation of WD could occur in childhood and appear as a decline in school performance inappropriate behavior or impulsiveness6 It is common to observe classic psychiatric syndromes in later early adulthood including behavioral and personality changes anxiety depression manic and hypomanic syndrome cognitive deficits 7-10 personality and behavioral disorder due to brain disease damage and dysfunction 11The BG are a structure capable of generating diverse psychiatric syndromes under dysfunctional conditions Cognitive impairment in WD patients with neuropsychiatric presentation is well described 12 and probably related to the cerebral lesions detected by MRI 13 WD patients will firstly experience prospective memory related to the planning or goal-making of daily activities 14 which is associated with gray matter loss in the basal ganglia and structural changes in frontal and occipital whiter matter 15
It is clinically relevant that the severity of neurologic symptoms commonly fluctuates sometimes during the same day Symptoms may be exacerbated by stress concurrent illnesses or medications 4 WD has been associated with multiple cognitive emotional or psychiatric disorders which may occur at any stage of disease 5 The first psychiatric manifestation of WD could occur in childhood and appear as a decline in school performance inappropriate behavior or impulsiveness6 It is common to observe classic psychiatric syndromes in later early adulthood including behavioral and personality changes anxiety depression manic and hypomanic syndrome cognitive deficits 7-10 personality and behavioral disorder due to brain disease damage and dysfunction 11The BG are a structure capable of generating diverse psychiatric syndromes under dysfunctional conditions Cognitive impairment in WD patients with neuropsychiatric presentation is well described 12 and probably related to the cerebral lesions detected by MRI 13 WD patients will firstly experience prospective memory related to the planning or goal-making of daily activities 14 which is associated with gray matter loss in the basal ganglia and structural changes in frontal and occipital whiter matter 15
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