Idiopathic Parkinson DiseaseBiomarParkNCT05110547
Multicenter Study of Blood Biomarkers of Mitochondrial and Peroxisomal Metabolism to Differentiate Idiopathic Parkinson's Disease From Related Conditions
An observational study of Idiopathic Parkinson Disease and Parkinsonian Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
With the aging of the population due to an increase in longevity, the number of people with Parkinson's disease is increasing (166,712 in France, as of December 31, 2015) and the number of patients with motor or cognitive-behavioral disorders is already a major public health challenge (1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Parkinson Disease, Parkinsonian Syndrome
- What is being tested?
- blood collection
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2021to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who regularly consult or are hospitalized at the Dijon University Hospital (in the Parkinson's disease unit) and at the Besancon University Hospital.
Who may be able to join
- For all patients:
- Person who was informed of the study and who did not object to inclusion
- Age ≥ 18 years
- Patient affiliated to national health insurance
- Onset of symptoms strictly more than 2 years and less than 7 years ago
- Patient with a recent brain MRI to exclude patients with secondary parkinsonism (vascular parkinson,hydrocephalus at normal pressure)
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- For patients in the "idiopathic Parkinson's disease group" :
- Idiopathic Parkinson's disease that is "possible," "probable," or "definite" according to UKPDSBB (UK Parkinson's Disease Society Brain Bank, Hughes et al. 1992) criteria.
- For patients in the "atypical parkinsonian syndrome" group:
- Subjects with a "possible" or "probable" diagnosis of MSA according to the diagnostic criteria of Gilman et al, 2008
- Or Subjects with a "possible" or "probable" diagnosis of AP according to the diagnostic criteria of Hoglinger et al, 2017
- Or Subjects with a "possible" or "probable" diagnosis of CBD according to the diagnostic criteria of Armstrong et al, 2013
Who cannot join
- For all patients:
- Disability making it impossible for him/her to participate in the trial due to lack of understanding of the information provided to him/her
- Patient under guardianship, curatorship or a measure of judicial protection
- Patients with any other neurological disease that could bias the results of our study: stroke, brain tumor, other neurodegenerative disease of the nervous system.
- Patients with secondary Parkinsonism (iatrogenic, toxic, inflammatory, post-traumatic)
- Patients with dyslipidemia receiving lipid-lowering treatment (statins, fibrates, inhibitors of intestinal cholesterol absorption).
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- Patients with a progressive systemic disease that affects cholesterol metabolism, peroxisomal or mitochondrial function. (Examples: familial hypercholesterolemia, mitochondriopathy, peroxisome biogenesis disorders, etc.)
- Patient with a chronic disability making it impossible to collect clinical and cognitive data.
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Thibault MOREAU, 03 80 29 30 31 ext. +33, thibault.moreau@chu-dijon.fr
About this study
With the aging of the population due to an increase in longevity, the number of people with Parkinson's disease is increasing (166,712 in France, as of December 31, 2015) and the number of patients with motor or cognitive-behavioral disorders is already a major public health challenge (1). In neurodegenerative diseases, the current strategy is to identify the disease early and, if possible, to consider therapeutic measures to slow down the progression of the disease.
Classically, when faced with the early stages of Parkinsonism, the investigators differentiate idiopathic Parkinson's disease (IPD) from atypical Parkinsonian syndromes (AP), which include multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive supranuclear palsy (PSP), for which the prognoses are more severe and the therapies less effective. In the early stage of the disease, when the symptoms are not do no yet differentiate the diseases, the differential diagnosis between IPD and PSP is a real challenge for clinicians (2). Cerebral MRI can help in the diagnosis but is most often only an indicator, as it may be normal in the early stages of the disease (2). The recent emergence of targeted therapies, specific to tauopathies or synucleinopathies, makes it essential to establish a diagnosis as early as possible in order to curb the evolution of the disease (3).
Read more
The investigators propose here a first study on the analysis of biomarkers of neurodegeneration from lipid metabolism allowing to discriminate IPD and AP from peripheral blood. Two recent studies have provided evidence of the discriminatory character of neurofilament blood testing in the early phases of parkinsonism (4,5). On the other hand, to our knowledge, none of them has studied markers from mitochondrial and peroxisomal metabolism, which could play a key role in the pathophysiology of these diseases (6,7,8,9,10).
Our strategy will therefore be to study idiopathic or atypical Parkinsonism subjects with a clearly established diagnosis in a cross-sectional manner, and to identify one or more blood markers of neurodegeneration predictive of IPD or AP, hypothesizing that these markers will be at significantly different levels between the two groups (descriptive analysis). The markers studied will include markers of neurodegeneration, markers of mitochondrial function, peroxisomal function and oxidative stress. The investigators will then study the correlations between these biomarkers and motor scores of disease severity.
- Being tested
- blood collection
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionBiological
2 additional 5ml EDTA tubes, with assays for the following markers: 24S and 27 hydroxycholesterol (gas chromatography-mass spectrometry, GC-MS), Neurofilaments (SIMOA), oxydative phosphorylation (OXPHOS) and quantitative measurement of intracellular ATP (ELISA), Very long chain fatty acids (GC-MS), Octanoyl CoA (HPLC), Uric acid, MDA assay (TBAR assay kit), and Lipid panel.
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Parkinson's disease | patients meeting the current clinical criteria whose disorders have progressed for strictly more than 2 years and strictly less than 7 years. Receives: Biological: blood collection | |
| atypical Parkinsonian syndromes | including the subgroups: multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration with a duration of disease progression strictly greater than 2 years and strictly less than 7 years, and meeting the current clinical criteria for each Receives: Biological: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic measurement of 24S and 27 hydroxycholesterol
Markers of neurodegeneration
Measured: Baseline
Plasmatic measurement on total leukocytes of the level of complexes 1 to 5 associated
Markers of mitochondrial function
Measured: Baseline
Plasma assay of very long chain fatty acids
Markers of peroxisomal function:
Measured: Baseline
Plasmatic measurement of ATP production
Markers of mitochondrial function
Measured: Baseline
Plasma and leukocyte determination of Octanoyl Coenzyme A
Markers reflecting the relationship between peroxisome and mitochondria:
Measured: Baseline
Dosage of uric acid
Markers of oxidative stress
Measured: Baseline
Dosage of malondialdehyde (MDA)
Markers of oxidative stress
Measured: Baseline
Plasmatic level of neurofilaments (SIMOA)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start27 Apr 2021
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110547
- Sponsor's protocol ID
- MOREAU 2020
- Acronym
- BiomarPark
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study of Blood Biomarkers of Mitochondrial and Peroxisomal Metabolism to Differentiate Idiopathic Parkinson's Disease From Related Conditions
- ClinicalTrials.gov ID
- NCT05110547
- Acronym / sponsor ID
- BiomarPark / MOREAU 2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the aging of the population due to an increase in longevity, the number of people with Parkinson's disease is increasing (166,712 in France, as of December 31, 2015) and the number of patients with motor or cognitive-behavioral disorders is already a major public health challenge (1). In neurodegenerative diseases, the current strategy is to identify the disease early and, if possible, to consider therapeutic measures to slow down the progression of the disease.
Classically, when faced with the early stages of Parkinsonism, the investigators differentiate idiopathic Parkinson's disease (IPD) from atypical Parkinsonian syndromes (AP), which include multiple system atrophy (MSA), corticobasal degeneration (CBD), and progressive supranuclear palsy (PSP), for which the prognoses are more severe and the therapies less effective. In the early stage of the disease, when the symptoms are not do no yet differentiate the diseases, the differential diagnosis between IPD and PSP is a real challenge for clinicians (2). Cerebral MRI can help in the diagnosis but is most often only an indicator, as it may be normal in the early stages of the disease (2). The recent emergence of targeted therapies, specific to tauopathies or synucleinopathies, makes it essential to establish a diagnosis as early as possible in order to curb the evolution of the disease (3).
The investigators propose here a first study on the analysis of biomarkers of neurodegeneration from lipid metabolism allowing to discriminate IPD and AP from peripheral blood. Two recent studies have provided evidence of the discriminatory character of neurofilament blood testing in the early phases of parkinsonism (4,5). On the other hand, to our knowledge, none of them has studied markers from mitochondrial and peroxisomal metabolism, which could play a key role in the pathophysiology of these diseases (6,7,8,9,10).
Our strategy will therefore be to study idiopathic or atypical Parkinsonism subjects with a clearly established diagnosis in a cross-sectional manner, and to identify one or more blood markers of neurodegeneration predictive of IPD or AP, hypothesizing that these markers will be at significantly different levels between the two groups (descriptive analysis). The markers studied will include markers of neurodegeneration, markers of mitochondrial function, peroxisomal function and oxidative stress. The investigators will then study the correlations between these biomarkers and motor scores of disease severity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Parkinson's disease | – | Biological: blood collectionpatients meeting the current clinical criteria whose disorders have progressed for strictly more than 2 years and strictly less than 7 years. |
| atypical Parkinsonian syndromes | – | Biological: blood collectionincluding the subgroups: multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration with a duration of disease progression strictly greater than 2 years and strictly less than 7 years, and meeting the current clinical criteria for each |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who regularly consult or are hospitalized at the Dijon University Hospital (in the Parkinson's disease unit) and at the Besancon University Hospital.
Key inclusion criteria (12 listed)
- Person who was informed of the study and who did not object to inclusion
- Age ≥ 18 years
- Patient affiliated to national health insurance
- Onset of symptoms strictly more than 2 years and less than 7 years ago
- Patient with a recent brain MRI to exclude patients with secondary parkinsonism (vascular parkinson,hydrocephalus at normal pressure)
Key exclusion criteria (9 listed)
- Disability making it impossible for him/her to participate in the trial due to lack of understanding of the information provided to him/her
- Patient under guardianship, curatorship or a measure of judicial protection
- Patients with any other neurological disease that could bias the results of our study: stroke, brain tumor, other neurodegenerative disease of the nervous system.
- Patients with secondary Parkinsonism (iatrogenic, toxic, inflammatory, post-traumatic)
- Patients with dyslipidemia receiving lipid-lowering treatment (statins, fibrates, inhibitors of intestinal cholesterol absorption).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood collection2 additional 5ml EDTA tubes, with assays for the following markers: 24S and 27 hydroxycholesterol (gas chromatography-mass spectrometry, GC-MS), Neurofilaments (SIMOA), oxydative phosphorylation (OXPHOS) and quantitative measurement of intracellular ATP (ELISA), Very long chain fatty acids (GC-MS), Octanoyl CoA (HPLC), Uric acid, MDA assay (TBAR assay kit), and Lipid panel. | Biological | Idiopathic Parkinson's disease, atypical Parkinsonian syndromes |
Primary outcome
Plasmatic measurement of 24S and 27 hydroxycholesterol
Time frame: Baseline
Markers of neurodegeneration
Plasmatic measurement on total leukocytes of the level of complexes 1 to 5 associated
Time frame: Baseline
Markers of mitochondrial function
Plasma assay of very long chain fatty acids
Time frame: Baseline
Markers of peroxisomal function:
Plasmatic measurement of ATP production
Time frame: Baseline
Markers of mitochondrial function
Plasma and leukocyte determination of Octanoyl Coenzyme A
Time frame: Baseline
Markers reflecting the relationship between peroxisome and mitochondria:
Dosage of uric acid
Time frame: Baseline
Markers of oxidative stress
Dosage of malondialdehyde (MDA)
Time frame: Baseline
Markers of oxidative stress
Plasmatic level of neurofilaments (SIMOA)
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Parkinson Disease and Parkinsonian Syndrome, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thibault MOREAU (03 80 29 30 31 ext. +33, thibault.moreau@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasmatic measurement of 24S and 27 hydroxycholesterol (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.