Wilson DiseaseNCT06179394
Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities
An observational study of Wilson Disease, run by Assiut University.
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… Read more about this study
- Who is it for?
- Ages 8 to 70 years
- Conditions the study is for
- Wilson Disease
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2023to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: all pt fulfilling inclusion criteria will including in my study except that we exculded .
Who may be able to join
- age 8-70, both sexes, diagnosed as Wilson disease.
Who cannot join
- • Patients with neurological symptoms due to neurological disease other than Wilson disease such as patients with cerebrovascular stroke or Parkinson disease, ……
- Patients with hepatic encephalopathy or severe neurological impairments (disabling dysarthria, tremor or dystonia) or severe psychiatric disorders incompatible with neuropsychological examination
- Patients with liver transplant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities in Patients With Wilson Disease
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.
Read the detailed 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).
- Conditions
- Wilson Disease
- Medical subject headings
- Hepatolenticular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation
- correlation of MRI brain findings with cognitive \& psychiatric symptoms found in the patients
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start15 Dec 2023 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wilson DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ahmed Sedky Abdallah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179394
- Sponsor's protocol ID
- Wilson disease
- Status last verified
- Dec 2023
- First submitted
- 12 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities in Patients With Wilson Disease
- ClinicalTrials.gov ID
- NCT06179394
- Acronym / sponsor ID
- Wilson disease
- Conditions
- Wilson Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all pt fulfilling inclusion criteria will including in my study except that we exculded .
Key inclusion criteria (1 listed)
- age 8-70, both sexes, diagnosed as Wilson disease.
Key exclusion criteria (3 listed)
- • Patients with neurological symptoms due to neurological disease other than Wilson disease such as patients with cerebrovascular stroke or Parkinson disease, ……
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation
Time frame: base line
• correlation of MRI brain findings with cognitive \& psychiatric symptoms found in the patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
Related trials for Wilson Disease
RecruitingPhase 3
Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
Wilson's Disease
RecruitingObservational study
Oral Health and Wilson's Disease: SOMAWI
Wilson Disease
RecruitingPhase 1/2
A Study of the Safety and Efficacy of Prime Editing (PM577) in Participants With Wilson Disease (WD)
Wilson Disease, Wilson's Disease
RecruitingObservational study
Description of Renal Involvement in Wilson's Disease
Wilson Disease
Recruiting
Cardiac Involvement in Wilson's Disease
Wilson's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Wilson Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa A Sedky Abd-ALLAH, resident (01093194172, sedky9752@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.