NL-OMON46465已完成不适用
A Phase 0 biomarker study in patients with Parkinson*s Disease and healthy controls - LRRK2 biomarkers in PD patients and controls
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Groups A and B
- •1. Confirmed clinical diagnosis of Parkinson*s disease by a qualified neurologist,
- •2. Hoehn and Yahr stage I-IV, inclusive,
- •3. Group A: Confirmed mutation in the Leucine-rich repeat kinase 2 (LRRK2) gene of the following types: G2019S, I2020T, R1441G, R1441C, R1441H, N1437H or Y1699C.
- •4. Group B: Confirmed wild type Leucine-rich repeat kinase 2 (LRRK2) gene.
- •5. Male or female of 30-85 years of age at screening (inclusive). Group A patients may be as young as 25 years of age with Investigatory and Sponsor agreement.
- •6. Body mass index (BMI) between 18 and 35 kg/m2 (inclusive), and with a minimum weight of 50 kg at screening.
- •7. Able to speak, read, and understand study procedures in Dutch sufficiently to allow completion of all study assessments.
- •8. Mentally competent as assessed by the screening physician and *if deemed necessary- by the treating neurologist
- •9. Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
- •10. 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.
- •11. Willing and able to abstain from alcohol 48 hours prior to all study procedures at study visits 1 and 2.;Group C:
- •1. No clinical evidence or history of Parkinson disease
- •2. Male or female matched to a participant in Group A and/or Group B for gender, race, age (+/- 5 years) and BMI (+/- 3.5, with a minimum weight of 50 kg at screening).
- •3. Able to speak, read, and understand study procedures in Dutch sufficiently to allow completion of all study assessments.
- •4. Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
- •5. Willing and able to maintain stable doses and regimens for all medications, herbal treatments, dietary supplements and caffeine intake from the screening visit through the last study visit.
- •6. Willing and able to abstain from alcohol 48 hours prior to all study procedures at study visits 1 and 2.
排除标准
- •Groups A * C
- •1. Self-reported substance or alcohol dependence (excluding caffeine), and/or participated in a substance or alcohol rehabilitation program to treat substance or alcohol dependence within the past 6 months
- •2. History or presence of clinically significant or unstable abnormality as assessed by physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, which in the opinion of the investigator would jeopardize the safety of the participant or the validity of the study results
- •3. Positive urine drug screen, except for medical marijuana which is permitted
- •4. Positive breath alcohol test. Participants with a positive result may be rescheduled at the investigator*s discretion
- •5. Groups A and B: Parkinson disease associated mutations in the GBA gene, as determined by genetic testing or documented before screening.
- •6. Group C only: first order relative with Parkinson disease
- •7. Females who have a positive serum or urine pregnancy test
- •8. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening
- •9. Hemoglobin level <7.0 mmol/L (males) or <6.0 mmol/L (females)
- •10. Donation or loss of more than 500 mL whole blood within 30 days preceding entry into the treatment period
- •11. Difficulty with venous access or unsuitable or unwilling to undergo catheter insertion
- •12. History of clinically significant back pathology and/or back injury (e.g. degenerative disease, spinal deformity or spinal surgery) that may predispose to complications or technical difficulty with lumbar puncture
- •13. Significant coagulation abnormality (e.g. hemophilia, platelet count <100,000/microliter or clinically significant elevation in PT or PTT at screening), or has a medical condition requiring treatment with an anticoagulant (e.g. warfarin) or with two or more antiplatelet agents
- •14. Treatment with an investigational drug within 5 times the elimination half-life or within 30 days (whichever is longer) prior to Visit 1, or is currently enrolled in any research judged not to be scientifically or medically compatible with this study
- •15. Hospitalization during the 6 weeks prior to Visit 1
- •16. An employee of the sponsor or research site personnel directly affiliated with this study or their immediate family members defined as a spouse, parent, child or sibling, whether biological or legally adopted
- •17. Anyone who, in the opinion of the investigator or designee, is not considered to be suitable and is unlikely to comply with the study protocol for any reason
- •18. Current smoker or tobacco use within 6 months
- •19. Groups B and C only: presence of Type 2 diabetes based on medical history or screening laboratories, unless matched to a patient from Group A with Type 2 diabetes
研究者
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