Exploratory Biomarker Study of Fatty Acid profiles in Healthy Volunteers and patients with Parkinson's Disease
- Conditions
- Parkinson's Disease10028037
- Registration Number
- NL-OMON48468
- Lead Sponsor
- Yumanity
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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.
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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Fatty-acid profiles of the following fatty acids:,<br /><br>* Saturated fatty acids in plasma including but not limited to: C16:0, C18:0<br /><br>* Unsaturated fatty acids (MUFAs and PUFAs) in plasma including but not limited<br /><br>to: C16:1n7t, C16:1n9, C16:1n7, C18:1t, C18:1n9, C18:2n6t, C18:2n6, C18:3n6,<br /><br>C20:1n9, C18:3n3, C20:2n6, C20:3n6, C20:4n6, C20:5n3, C24:1n9, C22:4n6,<br /><br>C22:5n6, C22:5n3, C22:6n3<br /><br><br /><br>Fatty-acid desaturation index (FA-DI) in plasma will be calculated from the<br /><br>respective fatty acid profiles:<br /><br>* Ratio between C16:1 and C16:0<br /><br>* Ratio between C18:1 and C18:0</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>