Parkinson's disease
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 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 study. 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 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 study. 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.
Exclusion criteria
Exclusion criteria: 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, ECG, laboratory findings and vital signs 3. Female participant is pregnant or planning to become pregnant during the study. 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 clinic 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. Parkinsons disease patients 15. Legal incapacity or inability to understand or comply with the requirements of the study 16. Any known PD-related gene mutations, except for GBA mutation. 17. Reside in a nursing home or assisted care facility 18. Clinically significant findings as determined by medical history taking, physical examination, ECG, laboratory findings and vital signs, other than Parkinson*s disease 19. 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 20. Female participant is pregnant or planning to become pregnant during the study. 21. 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. 22. Positive HBsAg, HCV Ab, or HIV Ab at screening 23. Consume, on average, >8 units/day of (methyl)xanthines (e.g., coffee, tea, cola, chocolate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize day-to-day, intra-individual and inter-individual variability of mitochondrial function in the brain measured with 31-P MRS of early onset PD patients, late onset PD patients, GBA mutation PD patients and healthy volunteers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize day-to-day, intra-individual and inter-individual variability of mitochondrial function measured in peripheral blood mononuclear cells or whole blood of early onset Parkinson*s disease patients, late onset Parkinson*s disease patients, GBA mutation Parkinson*s disease patients and healthy volunteers. Characterize day-to-day and inter-individual variability of circulating biomarkers in plasma in idiopathic early onset Parkinson*s disease patients, idiopathic late onset Parkinson*s disease patients, GBA mutation Parkinson*s disease patients and healthy volunteers. Characterize day-to-day, intra-individual and inter-individual variability of mitochondrial function in the skin of early onset Parkinson*s disease patients, late onset Parkinson*s disease patients, GBA mutation Parkinson*s disease patients and healthy volunteers. | — |
Countries
Netherlands
Outcome results
None listed