A phase 0 validation study in healthy male volunteers assessing the safety and tolerability of serial CSF sampling and to evaluate biomarkers related to Alzheimer*s disease in CSF and plasma

Completed

• Conditions: Alzheimer; 10029305

• Registration Number: NL-OMON36095
• Lead Sponsor: QPS Netherlands B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

Healthy men
Age 55-75
BMI 20-27 kg/m2

Exclusion Criteria

Any clinical significant abnormalities

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Investigate the safety and tolerability of 30 h continuous CSF sampling in<br /><br>healthy male subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Evaluate subject experiences of continuous CSF sampling using a standardized<br /><br>questionnaire. Gain experience with 30 h continuous CSF sampling. Evaluate ACh<br /><br>as an example of a biomarker related to Alzheimer in CSF and plasma.</p><br>