NL-OMON56229已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- 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.
排除标准
- •- Significant haematological abnormalities during screening such as anaemia
- •(haemoglobin level <7.0 mmol/L (males) or <6.0 mmol/L (females)), leukopenia,
- •or any other significant abnormalities in clinical laboratory test values. A
- •WBC distribution will be determined to ensure (near) normal WBC distribution as
- •determined by the investigator.
- •- Recent participation (<90 days / 5x T1/2) in an interventional study.
- •- Any other clinically significant neuro-degenerative disorder.
研究者
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