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Treatment of normal pressure hydrocephalus with acetazolamide
EU CTIS ID: 2024-514828-16-00
What this study is testing
To examine the effect of acetazolamide on gait in patients with normal pressure hydrocephalus
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of idiopatic normal pressure hydrocephalus according to international guidelines
- Age ≥50 years and ≤82 years
- Cognitive function with Mini-Mental State Examination > 20 points or cognitive domain of the iNPH scale ≥30 points
- MRI image for iNPH defined as callosal angle <95 degrees and dilated lateral ventricles or image as in disproportionately subarachnoid space hydrocephalus (DESH)
- Signed informed consent form
You likely can't join if
- Exclusion criteria for MRI examination
- Allergy to acetazolamide, sulfonamides, or sulfonamide derivatives
- Treatment with phenytoin, valproate, carbamazepine, lithium, thiazide-diuretics > 25mg/day, acetylsalicylic acid > 100 mg/day, daily use of NSAID or furosemide > 20 mg/day
- Inability to swallow capsules of the same size as the investigational medicinal products (will be tested using empty capsules when the patient as asked to participate in the study)
- Average walking time for the three walking tests < 10.5 seconds for men and <11.5 seconds for women
- Average walking time for the three walking tests > 50 seconds
See the full eligibility criteria
- Diagnosis of idiopatic normal pressure hydrocephalus according to international guidelines
- Age ≥50 years and ≤82 years
- Cognitive function with Mini-Mental State Examination > 20 points or cognitive domain of the iNPH scale ≥30 points
- MRI image for iNPH defined as callosal angle <95 degrees and dilated lateral ventricles or image as in disproportionately subarachnoid space hydrocephalus (DESH)
- Signed informed consent form
- Exclusion criteria for MRI examination
- Allergy to acetazolamide, sulfonamides, or sulfonamide derivatives
- Treatment with phenytoin, valproate, carbamazepine, lithium, thiazide-diuretics > 25mg/day, acetylsalicylic acid > 100 mg/day, daily use of NSAID or furosemide > 20 mg/day
- Inability to swallow capsules of the same size as the investigational medicinal products (will be tested using empty capsules when the patient as asked to participate in the study)
- Average walking time for the three walking tests < 10.5 seconds for men and <11.5 seconds for women
- Average walking time for the three walking tests > 50 seconds
- Inability to comply with the study treatment independently, and a concurrent lack of individuals to help the patient comply with the treatment during the study period
- Females who are not infertile or females of childbearing potential who do not use highly effective birth control. For females of childbearing potential a negative pregnancy test will be documented before inclusion
- Participation in another medical trial
- Other disease likely to impact the symptoms of the patient
- Wheelchair bound or in need of support when walking
- Reduced kidney function with creatinine GFR < 50
- Reduced liver function: Prothrombin complex > 1.2 or increased alanine transaminase concentrations in plasma 1.5 times above the upper reference value (women > 1.125 mkat/L; men > 1.65 mkat/L)
- Known heart failure
- Low concentrations of electrolytes in blood plasma, or other illness or treatment that may cause significant lowering of electrolyte concentrations according to the investigator
- Angle-closure glaucoma
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.