CompletedPhase 2

Acetazolamide Trial in Normal Pressure Hydrocephalus

Sweden50 participantsStarted 2022-02-17

Plain-language summary

A pharmacological treatment to patients with normal pressure hydrocephalus (NPH) is missing. The aim is to investigate if acetazolamide given to patients with NPH improves gait function and study the pathophysiological mechanisms leading to reduced symptoms. Patients will be randomized to acetazolamide or placebo and duration of treatment will be from diagnosis to the day of shunt surgery. Target dose is 500 mg/day. Study design is a double-blind randomized controlled trial and the plan is to include 42-50 patients. The study is investigator-initiated without financial sponsorship from the industry.

Who can participate

Age range

50 Years – 82 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Diagnosis of idiopathic 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 iNPH scale ≥ 30 points.
. MRI image characteristic of normal pressure hydrocephalus, defined as callosal angle \< 90 degrees and dilated lateral ventricles or pattern of disproportionately enlarged subarachnoid space hydrocephalus (DESH).
. Signed informed consent form

Exclusion criteria

. Exclusion criteria for MRI examination

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportional change in gait function

Timeframe: Change from baseline gait function immediately after intervention (at time of shunt surgery)

Trial details

NCT IDNCT04975269

SponsorUppsala University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-18

View on ClinicalTrials.gov More Idiopathic Normal Pressure Hydrocephalus (INPH) trials