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

Continuous CSF sampling gives the opportunity to correlate plasma
concentrations of endogenous molecules with CSF levels to be utilized for PK/PD
analysis. The purpose of this study is primarily to study the feasibility and
especially the safety and the burden for the healthy volunteers of serial CSF
sampling within the QPS environment in order to establish a standardized
research tool for future drug development studies.

The objective of this study is:
• To investigate the safety and tolerability of 30 h continuous CSF sampling in
healthy male subjects
• To evaluate subject experiences of continuous CSF sampling using a
standardized questionnaire.
• To gain experience with 30 h continuous CSF sampling
• To evaluate ACh as an example of a biomarker related to Alzheimer in CSF and
plasma.

This is an explorative study with 30 h continuous CSF sampling in healthy males

This research method have been performed in clinical research with healthy
volunteers and the tolerability in general was acceptable. A couple of
complaints related to this procedure are known from other studies. These are
identical to complaints related to lumbar puncture. These are headache
(post-spinal headache or Post Dural Puncture Headache, PDPH), back and neck
pain, pain at the location of the canula, dizziness, fainting and infection.
The risk of bleeding or nerve damage is very low.