Phase 0 biomarker study: assessment of day-to-day, within-day and inter-individual variability in β-Glucocerebrosidase activity and pathway biomarkers in healthy adults and patients with Parkinson*s disease with heterozygous GBA1-mutations.

Phase 0 biomarker study: assessment of day-to-day, within-day and inter-individual variability in β-Glucocerebrosidase activity and pathway biomarkers in healthy adults and patients with Parkinson*s disease with heterozygous GBA1-mutations. - GCase activity biomarker study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56229

Enrollment

Registered

2023-07-18

Start date

2023-07-17

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Parkinson's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Male or female 50-80 years of age at screening (inclusive). - BMI in the range of 18 - 32 kg/m2. - for patients: Confirmed clinical diagnosis of Parkinson disease by a neurologist, based on presence of bradykinesia and either resting tremor and/or muscular rigidity in at least one limb.

Exclusion criteria

Exclusion criteria: - Significant haematological abnormalities during screening such as anaemia (haemoglobin level

Design outcomes

Primary

Measure	Time frame
- Live Cell GCase activity in whole blood - GCase activity in dried blood spots	—

Secondary

Measure	Time frame
- Selected lipids including but not limited to: Glusphing, GluCer, Ceramide, Sphingomyelin and SAA in both plasma and CSF	—

Countries

Netherlands

Outcome results