Study on the Effects of Acetazolamide in Patients with Normal Pressure Hydrocephalus

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What is this study about?

This clinical trial is focused on studying the effects of a medication called acetazolamide on a condition known as normal pressure hydrocephalus. Normal pressure hydrocephalus is a brain disorder where excess fluid builds up in the brain’s ventricles, causing walking difficulties, memory problems, and bladder control issues. The trial will compare the effects of acetazolamide, which is a type of medication known as a carbonic anhydrase inhibitor, with a placebo. The placebo is a capsule that looks like the medication but does not contain any active ingredients.

The purpose of the study is to examine how acetazolamide affects walking in patients with normal pressure hydrocephalus. Participants in the study will be randomly assigned to receive either acetazolamide or the placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations about the treatment. The study will last for a period of up to nine months.

Throughout the study, participants will undergo various assessments to measure changes in their walking ability, quality of life, and other symptoms related to normal pressure hydrocephalus. These assessments will include walking tests, questionnaires about daily life, and brain scans using MRI to look at changes in the brain. Additionally, blood and cerebrospinal fluid samples will be collected to analyze specific proteins that may be related to the condition. The study aims to provide valuable information on whether acetazolamide can improve symptoms in people with normal pressure hydrocephalus.

1 joining the trial

Upon joining the trial, you will be required to sign an informed consent form. This document confirms your understanding of the trial and your agreement to participate.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes a diagnosis of normal pressure hydrocephalus and meeting specific criteria such as age between 50 and 82 years, and certain cognitive function scores.

An MRI scan will be conducted to check specific brain features related to the condition.

3 randomization

You will be randomly assigned to receive either the medication acetazolamide or a placebo. This process is double-blind, meaning neither you nor the researchers will know which one you are receiving.

4 medication administration

If you are assigned to the medication group, you will take acetazolamide orally. The dosage, frequency, and duration of administration will be provided by the trial team.

5 regular assessments

Throughout the trial, your gait will be assessed. This involves measuring the time and steps required to walk a distance of 10 meters, performing a timed up-and-go test, and walking backwards for 3 meters.

You will also complete questionnaires to assess your quality of life and any symptoms or side effects you experience.

6 additional evaluations

Additional evaluations will include brain MRI scans to analyze specific brain areas and tests to measure changes in motor skills, cognition, and continence.

Blood and cerebrospinal fluid samples may be collected to analyze certain proteins related to the condition.

7 completion of trial

The trial is expected to end by July 15, 2025. Upon completion, you will receive information about the results and any further steps if necessary.

Who Can Join the Study?

Diagnosis of idiopathic normal pressure hydrocephalus according to international guidelines. This means the patient has been diagnosed with a specific type of brain condition where fluid builds up in the brain.
Age between 50 and 82 years.
Cognitive function with a Mini-Mental State Examination score greater than 20 points or a cognitive domain score of the iNPH scale of 30 points or more. This means the patient should have a certain level of mental ability as measured by specific tests.
MRI image for iNPH defined as a callosal angle less than 95 degrees and dilated lateral ventricles, or an image showing disproportionately subarachnoid space hydrocephalus (DESH). This refers to specific findings on a brain scan.
Signed informed consent form. This means the patient agrees to participate in the study after being informed about it.

Who Cannot Join the Study?

Patients who do not have normal pressure hydrocephalus cannot participate. This is a condition where there is an abnormal buildup of fluid in the brain’s cavities, causing pressure.
Patients who are not within the specified age range cannot participate. The study is open to adults and older adults.
Patients who are not able to walk or have severe walking difficulties unrelated to normal pressure hydrocephalus cannot participate.
Patients with other serious medical conditions that could interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to give informed consent cannot participate. This means they must understand the study and agree to take part.
Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Usjdrzy Unirprguke Huxbprww	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	17.02.2022

Trial locations

Investigated drugs:

Acetazolamide Sodium

Acetazolamide is a medication that is being tested in this trial to see how it affects walking in people with a condition called normal pressure hydrocephalus. This condition can cause problems with walking, thinking, and bladder control. Acetazolamide is known to help reduce fluid buildup in the body, and in this trial, researchers want to find out if it can help improve walking by reducing fluid around the brain. The goal is to see if this medication can make it easier for patients to walk and improve their overall quality of life.

Investigated diseases:

Normal pressure hydrocephalus

Normal Pressure Hydrocephalus – Normal Pressure Hydrocephalus is a condition characterized by an abnormal buildup of cerebrospinal fluid in the brain’s ventricles, which are fluid-filled spaces. This accumulation occurs despite normal pressure readings, leading to the ventricles enlarging and potentially affecting brain function. The disease progresses with symptoms that typically include difficulty walking, urinary incontinence, and cognitive challenges such as memory problems. The walking difficulties often manifest as a shuffling gait, where the person may appear to be stuck to the ground. Over time, these symptoms can become more pronounced, affecting daily activities and quality of life. The condition is often seen in older adults and can be mistaken for other neurological disorders.

Trial ID:

2024-514828-16-00

Protocol code:

NPH-01

NCT ID:

NCT04975269

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Acetazolamide in Patients with Normal Pressure Hydrocephalus

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?