Evaluation of Cognitive Dysfunction & Psychiatric Comorbidities

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Wilson's 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 impulsiveness(6). 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' (11).The 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06179394
Study type	Observational
Source	Assiut University
Contact	Mustafa A Sedky Abd-ALLAH, resident
Phone	01093194172
Email	sedky9752@gmail.com
Status	Not yet recruiting
Phase
Start date	December 15, 2023
Completion date	March 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04573309` - Copper and Molybdenum Balance in Participants With Wilson Disease Treated With ALXN1840	Phase 2
Completed	`NCT03539952` - Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease	Phase 3
Active, not recruiting	`NCT04884815` - Study of UX701 Gene Transfer for the Treatment of Wilson Disease	Phase 1/Phase 2
Not yet recruiting	`NCT03659331` - A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease	N/A
Recruiting	`NCT05687474` - Baby Detect : Genomic Newborn Screening
Completed	`NCT04965571` - Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Terminated	`NCT05047523` - Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease	Phase 3
Completed	`NCT04526210` - Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants	Phase 1
Completed	`NCT00004338` - Study of Zinc for Wilson Disease	Phase 4
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Completed	`NCT02273596` - Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients	Phase 2
Completed	`NCT02763215` - The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
Recruiting	`NCT05444127` - Oral Health and Wilson's Disease: SOMAWI
Completed	`NCT04408300` - Study of Retinal Vascular Parameters in Patients With Wilson's Disease	N/A
Active, not recruiting	`NCT05783687` - Real World Evidence Study in Subjects With Wilson's Disease
Terminated	`NCT04909346` - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed	`NCT03867526` - Establishment of Human Cellular Disease Models for Wilson Disease
Enrolling by invitation	`NCT03589820` - Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure	N/A
Completed	`NCT04526197` - Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.	Phase 1
Not yet recruiting	`NCT06430359` - Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms