European Study of Prodromal iNPH
Key facts
- Where
- Bologna, ItalySee the site
Where in Italy
- Bellaria HospitalBologna, ItalyContact: Giorgio Palandri, MD, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Johan Virhammar
- Trial code
- NCT05910944
- Record updated
- 30 April 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; Age > 65 years; iNPH diagnosis according to international guidelines.19; Age matched with the individual in Group 1 (+/- 3 years).
Exclusion: Previously known relevant neurological disease; Previous stroke (clinical stroke, not only radiologically verified); Other serious disease with expected survival less than three years; Other serious disease with expected survival less than three years; Contraindication for MRI; 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; Imaging findings meet inclusion criteria of Group 1; Pathological gait pattern with unknown reason; MMSE < 27 or MoCA < 26; Anticoagulants in a dose that hinders lumbar puncture.