Parkinson's Disease
Conditions
Interventions
None listed
Sponsors
Yumanity
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male or female subjects 35-80 years of age, inclusive. Healthy status is defined by absence of evidence of any active acute or chronic disease or illness following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry and urinalysis; deemed by the investigator to be clinically significant; OR: Male or female subjects 40-75 years of age, with a confirmed diagnosis of Parkinson*s disease (Hoehn and Yahr grade 1-4) inclusive; 2. Body mass index (BMI) between 18-35 kg/m2, inclusive, and with a minimum weight of 50kg and maximum weight of 120kg; 3. Evidence of a personally signed, dated and witnessed informed consent document indicating that the subject has been informed of all pertinent aspects of the study; 4. Able and willing to give written informed consent and to comply with any and all study restrictions.
Exclusion criteria
Exclusion criteria: 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 and vital signs, which, in the opinion of the Investigator, does not allow study participation. 3. Any current, clinically significant, known medical condition other than Parkinson*s disease. Patients with a diagnosis of other neurological diseases, including Alzheimer*s disease, Huntington*s disease, vascular dementia, epilepsy, etc., will not be eligible for this study. 4. Have a urine drug screen detecting illicit drug(s) of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamine, MDMA) or positive alcohol breath test at screening, with exception of positive urine drug screens caused by prescribed drugs, such as benzodiazepines for PD sleeping disorders; 5. Consume, on average, >8 units/day of (methyl)xanthines (e.g., coffee, tea, cola, chocolate); 6. History or clinical evidence of alcoholism or drug abuse; 7. Smoking of >5 cigarettes/day or equivalent; 8. Use of prescription, illicit or herbal medication within 7 days of study initiation, except for contraception or their current standard of care medications for the treatment of parkinsonism; 9. Simultaneous participation in a clinical trial more than 4 times in the previous year; 10. Being on a diet composed of relevantly altered amounts of fat, protein or carbohydrates that may affect triglyceride and fatty acid levels. 11. Loss of blood * 500ml within 3 months before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatty-acid profiles of the following fatty acids:, * Saturated fatty acids in plasma including but not limited to: C16:0, C18:0 * Unsaturated fatty acids (MUFAs and PUFAs) in plasma including but not limited to: C16:1n7t, C16:1n9, C16:1n7, C18:1t, C18:1n9, C18:2n6t, C18:2n6, C18:3n6, C20:1n9, C18:3n3, C20:2n6, C20:3n6, C20:4n6, C20:5n3, C24:1n9, C22:4n6, C22:5n6, C22:5n3, C22:6n3 Fatty-acid desaturation index (FA-DI) in plasma will be calculated from the respective fatty acid profiles: * Ratio between C16:1 and C16:0 * Ratio between C18:1 and C18:0 | — |
Countries
Netherlands
Outcome results
None listed