To investigate if progression from prodromal into symptomatic NPH can be predicted from advanced neuroimaging, biomarkers in cerebrospinal fluid (CSF) and plasma and investigate the unknown mechanisms causing deterioration by investigating longitudinal changes in the above-mentioned variables. Three different cohorts with both asymptomatic and symptomatic patients as well as healthy controls will be investigated over time, both without intervention and before and after shunt surgery.
Who can participate
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 - Group 1 - prodromal iNPH
* Brain imaging with both:
* Evans index \> 0.3
* Callosal angle ≤ 90 º or:
* Disproportionately enlarged subarachnoid space hydrocephalus (DESH) - defined as: enlarged ventricles, dilated sylvian fissures and tight sulci at the high convexity.
* Absence of symptoms or too mild symptoms to motivate shunt surgery according to local routine, and all of the following:
* Normal gait pattern, or slight disturbance of the gait pattern that is not considered to be caused by a disease in the central nervous system (CNS).
* Gait velocity (maximum gait speed), men ≥ 1.4 m/s; women ≥ 1.25 m/s.
* Rombergs test with eyes open \> 60 seconds
* Mini Mental State Examination (MMSE) ≥ 27 or Montreal Cognitive Assessment (MoCA) ≥ 23
* Informed consent
Exclusion criteria - Group 1 - prodromal iNPH
* Contraindication for MRI
* Other serious disease with expected survival less than three years
* Other type of hydrocephalus:
* non-communicating hydrocephalus
* secondary communicating hydrocephalus
* suspected congenital hydrocephalus (severely enlarged ventricles, narrow sylvian fissures and normal non-compressed sulci at the high convexity or morphological findings consistent with PaVM18)
* Anticoagulants in a dose that hinders lumbar puncture
Inclusion criteria - Group 2 - healthy controls
• Age \> 65 years
Exclusion criteria - Group 2 - healthy controls:
* Imaging findings meet inclusion criteria of Group 1
* Previously …
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
1
Frequency of patients with prodromal iNPH that requires shunt surgery within 6 years from inclusion.
Timeframe: From date of inclusion until decision of shunt surgery, assessed up to 72 months
2
Frequency of patients with prodromal iNPH that progress to symptomatic iNPH
Timeframe: From date of inclusion until 20 points reduction in total iNPH-scale score or 20% reduction in gait speed, assessed up to 72 months
3
Post operative improvement in iNPH-scale score in patients with mild, moderate and severe preoperative symptoms
Timeframe: Change from preoperative (last visit before surgery) iNPH scale at 3 months, 12 months, 36 months and 60 months follow-up.