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

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 - serial CSF sampling study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36095

Enrollment

Registered

2011-07-08

Start date

2011-09-05

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

Alzheimer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Any clinical significant abnormalities

Design outcomes

Primary

Measure	Time frame
Investigate the safety and tolerability of 30 h continuous CSF sampling in healthy male subjects	—

Secondary

Measure	Time frame
Evaluate subject experiences of continuous CSF sampling using a standardized questionnaire. Gain experience with 30 h continuous CSF sampling. Evaluate ACh as an example of a biomarker related to Alzheimer in CSF and plasma.	—

Countries

Netherlands

Outcome results