PH SILK

Phase 1

• Conditions: Idiopathic normal pressure hydrocephalus (iNPH); MedDRA version: 20.0Level: PTClassification code 10029773Term: Normal pressure hydrocephalusSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-004664-22-FI
• Lead Sponsor: Kuopio University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-21
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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