NPH SILK

Stable Isotope Labeling Kinetics in Normal Pressure Hydrocephalus: implications for neurodegeneration - NPHSILK

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004664-22-FI

Enrollment

Registered

2020-04-21

Start date

2020-06-18

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic normal pressure hydrocephalus (iNPH) MedDRA version: 20.0 Level: PT Classification code 10029773 Term: Normal pressure hydrocephalus System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: 13C6 leucine Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed probable iNPH with CSF shunt. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Bleeding disorder, active anticoagulation, active infection, taking an experimental treatment that could influence protein levels in the CSF, allergy/sensitivity to study medications or their ingredients, female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study, subjects unable to provide written informed consent, any other significant disease or disorder (including uncontrolled diabetes, unstable ischemic heart disease, severe congestive heart failure) which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study; nown history of, or documented positive hepatitis B or C or HIV infection; clinically significant ECG findings as judged by the investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: Measure in vivo production of amyloid isoforms in subjects with and without mutations that increase risk of AD or protect against AD.;Secondary Objective: Measure clearance rates of amyloid isoforms in subjects with and without mutations that increase risk of AD or protect against AD.;Primary end point(s): End of sampling.;Timepoint(s) of evaluation of this end point: 30 hours after initiation	—

Measure

Time frame

Main Objective: Measure in vivo production of amyloid isoforms in subjects with and without mutations that increase risk of AD or protect against AD.;Secondary Objective: Measure clearance rates of amyloid isoforms in subjects with and without mutations that increase risk of AD or protect against AD.;Primary end point(s): End of sampling.;Timepoint(s) of evaluation of this end point: 30 hours after initiation

—

Secondary

Measure	Time frame
Secondary end point(s): Any significant adverse event.;Timepoint(s) of evaluation of this end point: Any point during investigational infusion or sampling.	—

Countries

Finland

Contacts

Public ContactNeurosurgery

Kuopio University Hospital

ville.leinonen@kuh.fi+358442303

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026