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Wilson DiseaseNCT06179394

Evaluation of Cognitive Dysfunction and Psychiatric Comorbidities

An observational study of Wilson Disease, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mustafa A Sedky Abd-ALLAH, resident contact

01093194172

sedky9752@gmail.com

Anwar M Ali, prof contact

01030361010

anwarmoha2006@aun.edu.eg

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.

  1. 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.

  1. First posted21 Dec 2023
  2. Study start15 Dec 2023 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

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)
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

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.

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