Assessment of mitochondrial function measurements in Parkinson's disease patients and healthy volunteers to identify new potential biomarkers.

• Conditions: Parkinson's disease; 10028037

• Registration Number: NL-OMON56963
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 32

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 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
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 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
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

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
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.
15. Use of drugs with suspected
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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
study.
22 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 pr

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Characterize day-to-day, intra-individual and inter-individual variability of<br /><br>mitochondrial function in the brain measured with 31-P MRS of early onset PD<br /><br>patients, late onset PD patients, GBA mutation PD patients and healthy<br /><br>volunteers.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Characterize day-to-day, intra-individual and inter-individual variability of<br /><br>mitochondrial function measured in peripheral blood mononuclear cells or whole<br /><br>blood of early onset Parkinson*s disease patients, late onset Parkinson*s<br /><br>disease patients, GBA mutation Parkinson*s disease patients and healthy<br /><br>volunteers.<br /><br><br /><br>Characterize day-to-day, intra-individual and inter-individual variability of<br /><br>mitochondrial function in the skin of early onset Parkinson*s disease patients,<br /><br>late onset Parkinson*s disease patients, GBA mutation Parkinson*s disease<br /><br>patients and healthy volunteers. </p><br>