NL-OMON56963尚未招募不适用
Assessment of mitochondrial function measurements in Parkinson's disease patients and healthy volunteers to identify new potential biomarkers. - Mitochondrial function measurements in Parkinson*s disease patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
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
- •Healthy volunteers:
- •1. Adult male or female subjects 50 years of age or older, inclusive.
- •2. Healthy status as defined by absence of evidence of any significant active
- •acute or chronic disease or illness following a detailed medical and surgical
- •history, a complete physical and neurological examination including vital
- •signs, 12-lead ECG, haematology, blood chemistry and urinalysis, as judged by
- •the investigator,
- •3. Body mass index (BMI) between 18-32 kg/m2, inclusive.
- •4. Evidence of a personally signed and witnessed informed consent document
- •indicating that the subject has been informed of all pertinent aspects of the
- •5. Women of childbearing potential must use an effective form of contraception
- •(e.g., oral contraceptive, condom use, intrauterine device (IUD), abstinence of
- •heterosexual intercourse) during the study.
- •Parkinsons disease patients:
- •6. Adult male or female subjects 50 years of age or older, inclusive, with a
- •confirmed diagnosis of Parkinson*s disease (Hoehn and Yahr grade 1-3).
- •7. Healthy status as defined by absence of evidence of any significant active
- •acute or chronic disease or illness following (apart from Parkinson*s disease)
- •a detailed medical and surgical history, a complete physical and neurological
- •examination including vital signs, 12-lead ECG, haematology, blood chemistry
- •and urinalysis, as judged by the investigator.
- •8. BMI between 18-32 kg/m2, inclusive.
- •9. Evidence of a personally signed and witnessed informed consent document
- •indicating that the subject has been informed of all pertinent aspects of the
- •10. Women of childbearing potential must use an effective form of contraception
- •(e.g., oral contraceptive, condom use, IUD, abstinence of heterosexual
- •intercourse) during the study.
排除标准
- •Healthy subjects
- •1. Legal incapacity or inability to understand or comply with the requirements
- •of the study
- •2. Clinically significant findings as determined by medical history taking,
- •physical examination, fundoscopy, ECG, laboratory findings and vital signs
- •3. Female participant is pregnant or planning to become pregnant during the
- •4. Have a urine drug screen detecting illicit drug(s) of abuse (morphine,
- •benzodiazepines, cocaine, amphetamine, THC) or positive alcohol breath test at
- •screening. A positive urine drug screen for prescribed medication is allowed at
- •the discretion of the investigator.
- •5. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),
- •or human immunodeficiency virus antibody (HIV Ab) at screening
- •6. Consume, on average, >8 units/day of (methyl)xanthines (e.g., coffee, tea,
- •cola, chocolate) and not able to refrain from use during each stay at the CHDR
- •7. History or clinical evidence of drug abuse
- •8. History (within 3 months of screening) of alcohol consumption exceeding 2
- •standard drinks per day on average. Unwillingness or inability to refrain from
- •alcohol consumption at least 24 hours before screening and before each
- •scheduled visit.
- •9. Smoking of >5 cigarettes/day or equivalent and unwillingness or inability to
- •refrain from tobacco usage within 12 hours before each visit until the end of
- •that visit.
- •10. Loss of blood >= 500 ml within 3 months before screening
- •11. Presence of any contraindication to have magnetic resonance imaging (MRI)
- •scans with checkerboard stimulus performed (e.g. claustrophobia, pacemaker,
- •intracranial clips, deep brain stimulation, photosensitive epilepsy etc.).
- •12. Participation in a clinical trial including an investigational medicinal
- •product within 90 days of screening or more than 4 times within a year.
- •13. A visual acuity below -10 or above +10
- •14. Not being able to lay still and flat on back for 30-60 minutes.
- •15. Use of drugs with suspected
- •**********************************************************************
- •mitochondrial toxicity like statins, metformin and thiazolidinedione class
- •medications.
- •Parkinson's disease patients
- •16. Legal incapacity or inability to understand or comply with the requirements
- •of the study
- •17. Any known PD-related gene mutations, except for GBA mutation.
- •18. Reside in a nursing home or assisted care facility
- •19. Clinically significant findings as determined by medical history taking,
- •physical examination, fundoscopy, ECG, laboratory findings and vital signs,
- •other than Parkinson*s disease
- •20. Any current, clinically significant, known medical condition other than
- •Parkinson*s disease. Patients with a diagnosis of neurological diseases, other
- •than Parkinson*s disease, including Alzheimer*s disease, Huntington*s disease,
- •vascular dementia, progressive supranuclear gaze palsy, multiple system
- •atrophy, drug-induced parkinsonism, essential tremor, primary dystonia,
- •epilepsy, etc., that are considered clinically relevant by the investigator
- •21. Female participant is pregnant or planning to become pregnant during the
- •22 Have a urine drug screen detecting illicit drug(s) of abuse (morphine,
- 另有 2 项未显示
研究者
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