NL-OMON52359已完成不适用
Phase 0 biomarker assessment of day-to-day, within-day and interindividual variability in GBA pathway biomarkers in healthy adults and patients with Parkinson*s disease with and without heterozygous GBA1-mutations - GCase variability in GBA mutation
BIAL R&D INVESTMENTS, S.A0 个研究点目标入组 48 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
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
- •Group 1 (healthy volunteers)
- •1. Male or female 18 * 55 years of age at screening (inclusive)
- •2. BMI in the range of 18 * 32 kg/m2.
- •Group 1 (healthy volunteers)
- •1. Male or female 18 * 65 years of age at screening (inclusive)
- •2. BMI in the range of 18 * 32 kg/m2.
- •Cohort A and B
- •Group 2 and 3 (PD-GBA+ and PD-GBA-)
- •3. Confirmed clinical diagnosis of Parkinson disease by a qualified neurologist.
- •4. Hoehn and Yahr stage I-IV, inclusive
- •5. Male or female of 30-85 years of age at screening (inclusive)
- •6. BMI in the range of 18 * 32 kg/m2.
- •7. PD-GBA+ group (2): confirmed presence of GBA1 mutation via (historic)
- •8. PD-GBA- group (3): confirmed absence of GBA1 mutation via (historic)
- •Groups 1, 2 and 3
- •9. Able to speak, read, and understand study procedures in Dutch sufficiently
- •to allow completion of all study assessments.
- •10. Must understand and provide written informed consent prior to the
- •initiation of any protocol-specific procedures.
- •11. Willing and able to maintain stable doses and regimens for all medications,
- •herbal treatments, medical marijuana, dietary supplements and caffeine intake
- •from the screening visit through the last study visit.
- •12. Willing and able to abstain from alcohol 24 hours prior to all study
- •procedures at study visits 1, 2 and 3.
- •13. Women of childbearing potential must use a form of birth control (e.g. oral
- •contraceptive, condom use, IUD, abstinence of hetero-sexual intercourse)
排除标准
- •Group 1 and 2 and 3
- •1. Significant haematological abnormalities during screening such as anaemia,
- •leukopenia, (haemoglobin level <7.0 mmol/L (males) or <6.0 mmol/L (females)),
- •or any other significant abnormalities in clinical laboratory test values.
- •2. Recent participation (<90 days / 5x T1/2) in an interventional study for
- •Parkinson disease
- •3. Any other clinically significant neuro-degenerative disorder
- •4. Recent blood loss or blood donation (>500mL whole blood) in the past 30 days.
- •5. Recent infection with hospital admission (<1 month)
- •6. Alcohol or drugs abuse in the past 12 months
- •7. Have no clinical or electrocardiographic signs of ischemic heart disease as
- •determined by the Investigator with normal cardiac intervals appropriate for
- •their gender. The Screening 12 lead ECG conduction intervals must be within
- •gender specific normal range (e.g., QTcf female *470 msec QTcF males *450 msec,
- •PR interval *220 msec).
- •8. Vital sign measurements must be within the following ranges during
- •a. body temperature, >35C to *38C
- •b. systolic blood pressure, >90 to *160 mm Hg
- •c. diastolic blood pressure, >40 to *95 mm Hg
- •d. pulse rate, >40 to *100 bpm
- •9. Positive serology for human immunodeficiency virus (HIV), hepatitis B virus
- •(HBV) (positive hepatitis B core antibody [anti-HBc] with negative hepatitis B
- •DNA is acceptable), or hepatitis C virus (HCV) (treated/resolved hepatitis C
- •with negative polymerase chain reaction [PCR] RNA is allowed)
- •10. Any other issue that, in the opinion of the investigator, would make the
- •participant ineligible for study participation
- •11. Clinical evidence or history of Parkinson disease, parkinsonism or Gaucher
- •12. First order relative with Parkinson disease or Gaucher disease
- •13. Any historyof unstable or poorly controlled psychiatric, endocrine,
- •pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal,
- •metabolic, hematologic, immunologic, or allergic disease, or other major
- •disorders. Well-controlled conditions are permitted if investigator and Sponsor
研究者
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