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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06083233
Other study ID # MC00002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University Hospital Hradec Kralove
Contact Miroslav Cihlo, M.D.
Phone +420495832550
Email miroslav.cihlo@fnhk.cz
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Normal pressure hydrocephalus (NPH) is a neurodegenerative disease of unclear etiology characterized by a clinical trias named after the neurosurgeon Hakim. It includes cognitive impairment (dementia), gait disturbance, and urinary incontinence. These symptoms, which frequently occur in the elderly population, often overlap with the symptoms of "other" neurodegenerative diseases, especially Alzheimer's disease and other (pre)senile dementias. To distinguishing NPH from "other" dementias is crucial in determining whether a patient will benefit from a surgical procedure (ventriculoperitoneal shunt placement) or not. At the same time, the options for assessing the patient's condition's progression and distinguishing between the progression of neurodegeneration in a broader sense or malfunction of the drainage system are very limited. Therefore, the role of a biomarker that could meet these expectations mentioned above is highly desirable.


Description:

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Study Design


Intervention

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Locations

Country Name City State
Czechia University Hospital Hradec Kralove Hradec Králové

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Hradec Kralove

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of levels of the mentioned biomarkers Comparison of levels of the mentioned biomarkers between patients with clinically proven shunt-responsive and shunt-nonresponsive hydrocephalus 6 month
Secondary Comparison of levels of the biomarkers during follow-up To follow-up the development of the mentioned biomarker levels during follow-up, comparing them to the evolution of the clinical condition, and exploring the correlation between the levels of individual biomarkers in relation to the monitored parameters of the clinical condition (gait measured by 5-meter-walking test, mini-mental state examination, hydrocephalus parameters by computed tomography or magnetic resonance) 6 month
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