Parkinsonian SyndromesBIOPARKNCT02114242
Biomarkers in Parkinsonian Syndromes
An observational study of Parkinsonian Syndromes and Parkinson's Disease, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates in PSP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinsonian Syndromes, Parkinson's Disease, Multiple System Atrophy
- What is being tested?
- CSF, blood and urine sampling and clinical measures of disease severity and progression
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Dec 2013to 16 Dec 2025
- 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 suffering from parkinson disease or multiple system atrophy or progressive supranuclear palsy.
Who may be able to join
- Patients suffering from PD according to clinical criteria (Hughes et al, 1992)
- Written informed consent
- Patient covered by the national health system
- Patients suffering from "possible" or "probable" MSA according to clinical consensus criteria (Gilman et al, 2008), age > 30
- Written informed consent
- Patient covered by the national health system
Show all 9Show fewer
- Patients suffering from PSP according to NNIPPS trial criteria (Bensimon et al., 2009), age > 40
- Written informed consent
- Patient covered by the national health system
Who cannot join
- Patient under tutelage
- patient covered by the national health system
- MSA patients
- UMSARS IV score >4 points
- Patient under tutelage
- PSP patients
- PSPRS item 26 score >3 points
- Patient under tutelage
Trial locations and contacts
3 sites in 1 country.
Wassilios MEISSNER, Pr contact
France3 sites, 3 recruiting
- Recruiting
CHU de Limoges
Limoges, 87000
Frédéric Torny, MD
Frédéric Torny, MD
- Recruiting
CHU de Bordeaux
Pessac, 33640
Wassilios MEISSNER, Pr
Wassilios MEISSNER, Pr
- Not yet recruiting
CHU de Toulouse
Toulouse, 31000
Olivier RASCOL, Pr
Olivier RASCOL, PR
About this study
Official title: Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes
Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and PSP remains an unmet need. Such biological markers are crucial for future disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature in PD and MSA. The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.
The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling at two study visits (baseline and after 12 months). Major secondary objectives are (i) to assess potential associations between the biomarker and clinical measures of disease severity and progression in MSA and PSP, and (ii) to assess the variation of the biomarker and its correlation to disease severity and progression in PD, MSA and PSP.
Read the detailed description
The differential diagnosis between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy can be very difficult in early disease. PD, MSA and PSP are neurodegenerative disorders. PD and MSA belong to the alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. Alpha-synuclein accumulates in intraneuronal Lewy bodies in PD patients and as intracytoplasmic glial inclusions in MSA. In PSP, tau protein accumulates in neurons and glia cells while alpha-synuclein deposits are only found to a small extend.
The development of biological markers for the diagnosis and prognosis of PD, MSA and PSP remains an unmet need. Beyond guiding clinical decision-making, such biological markers are crucial for future disease-modification and neuroprotection trials.
Alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature of PD and MSA. The oligomeric alpha-synuclein fraction whose CSF levels are increased in PD seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.
The main objective of the study is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. Secondary objectives are (i) to compare total alpha-synuclein levels and the index total/oligomeric alpha-synuclein between PD, MSA and PSP, (ii) to study the correlation and concordance between CSF and plasma levels of total and oligomeric alpha-synuclein, (iii) to assess potential associations between the biomarker and clinical measures of disease severity and progression and (iv) to assess the variation of the biomarker over time and its correlation to disease severity and progression.
- Conditions
- Parkinsonian Syndromes, Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- Being tested
- CSF, blood and urine sampling, clinical measures of disease severity and progression
- Keywords
- Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, alpha-synuclein
- Medical subject headings
- Parkinsonian Disorders, Parkinson Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSF, blood and urine samplingOther
PSP and MSA patients will receive CSF and blood sampling at two study visits (baseline and after 12 months).
clinical measures of disease severity and progressionOther
Questionnaires (quality of life, motricity scales, cognitive scales, depression scales, scale of sleep quality)
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Patients suffering from Parkinson desease Receives: Other: clinical measures of disease severity and progression | |
| multiple system atrophy patients | Patients suffering from "probable" multiple system atrophy according to clinical consensus criteria and age > 30 Receives: Other: CSF, blood and urine sampling; Other: clinical measures of disease severity and progression | |
| progressive supranuclear palsy | Patients suffering from progressive supranuclear palsy and age > 40 Receives: Other: CSF, blood and urine sampling; Other: clinical measures of disease severity and progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of oligomeric alpha-synuclein in cerebrospinal fluid
Measured: at day 0 (inclusion) and one year after inclusion
Secondary outcomes (4)
Total alpha-synuclein concentration in CSF, oligomeric/total alpha-synuclein ratio in CSF
Measured: At inclusion (Day 0) and one year after inclusion
Oligomeric and total alpha-synuclein concentration in plasma, oligomeric/total alpha-synuclein ratio in plasma
Measured: At inclusion (Day 0) and one year after inclusion
Alpha-synuclein levels in relation to disease severity and progression, disease duration and age
Measured: At inclusion (Day 0) and one year after inclusion
Variation of alpha-synuclein levels between first and second sampling
Measured: At inclusion (Day 0) and one year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start16 Dec 2013
- Primary completion16 Dec 2023 (estimated)
- Study completion16 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinsonian SyndromesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wassilios MEISSNER, Pr, Principal investigator, University Hospital, BordeauxRodolphe THIEBAUT, MD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114242
- Sponsor's protocol ID
- CHUBX 2012/27
- Acronym
- BIOPARK
- Status last verified
- Mar 2022
- First submitted
- 6 Feb 2014
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Biomarkers for the Diagnosis and Prognosis of Parkinsonian Syndromes Running Head: Biomarkers in Parkinsonian Syndromes
- ClinicalTrials.gov ID
- NCT02114242
- Acronym / sponsor ID
- BIOPARK / CHUBX 2012/27
- Conditions
- Parkinsonian Syndromes, Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy
- Keywords
- Parkinson's disease, multiple system atrophy, progressive supranuclear palsy, alpha-synuclein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 16 Dec 2023 (estimated)
- Study completion
- 16 Dec 2025 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- 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.
Parkinson disease (PD), multiple system atrophy (MSA) and progressive supranuclear palsy (PSP) are neurodegenerative disorders. PD and MSA are alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein, while tau protein accumulates in PSP. The development of biological markers for the diagnosis and prognosis in PD, MSA and PSP remains an unmet need. Such biological markers are crucial for future disease-modification and neuroprotection trials. Alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature in PD and MSA. The oligomeric alpha-synuclein seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.
The main objective is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. PD and MSA patients will receive Cerebrospinal Fluid (CSF) and blood sampling at two study visits (baseline and after 12 months). Major secondary objectives are (i) to assess potential associations between the biomarker and clinical measures of disease severity and progression in MSA and PSP, and (ii) to assess the variation of the biomarker and its correlation to disease severity and progression in PD, MSA and PSP.
Detailed description
The differential diagnosis between Parkinson's disease, multiple system atrophy and progressive supranuclear palsy can be very difficult in early disease. PD, MSA and PSP are neurodegenerative disorders. PD and MSA belong to the alpha-synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. Alpha-synuclein accumulates in intraneuronal Lewy bodies in PD patients and as intracytoplasmic glial inclusions in MSA. In PSP, tau protein accumulates in neurons and glia cells while alpha-synuclein deposits are only found to a small extend.
The development of biological markers for the diagnosis and prognosis of PD, MSA and PSP remains an unmet need. Beyond guiding clinical decision-making, such biological markers are crucial for future disease-modification and neuroprotection trials.
Alpha-synuclein has a high potential for biomarker development since it constitutes the pathological hallmark feature of PD and MSA. The oligomeric alpha-synuclein fraction whose CSF levels are increased in PD seems to be particularly involved in abnormal protein aggregation in alpha-synucleinopathies.
The main objective of the study is to compare oligomeric alpha-synuclein CSF levels between PD, MSA and PSP patients. Secondary objectives are (i) to compare total alpha-synuclein levels and the index total/oligomeric alpha-synuclein between PD, MSA and PSP, (ii) to study the correlation and concordance between CSF and plasma levels of total and oligomeric alpha-synuclein, (iii) to assess potential associations between the biomarker and clinical measures of disease severity and progression and (iv) to assess the variation of the biomarker over time and its correlation to disease severity and progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Other: clinical measures of disease severity and progressionPatients suffering from Parkinson desease |
| multiple system atrophy patients | – | Other: CSF, blood and urine sampling, Other: clinical measures of disease severity and progressionPatients suffering from "probable" multiple system atrophy according to clinical consensus criteria and age > 30 |
| progressive supranuclear palsy | – | Other: CSF, blood and urine sampling, Other: clinical measures of disease severity and progressionPatients suffering from progressive supranuclear palsy and age > 40 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from parkinson disease or multiple system atrophy or progressive supranuclear palsy.
Key inclusion criteria (9 listed)
Key exclusion criteria (8 listed)
- MSA patients
- PSP patients
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 |
|---|---|---|
| CSF, blood and urine samplingPSP and MSA patients will receive CSF and blood sampling at two study visits (baseline and after 12 months). | Other | multiple system atrophy patients, progressive supranuclear palsy |
| clinical measures of disease severity and progressionQuestionnaires (quality of life, motricity scales, cognitive scales, depression scales, scale of sleep quality) | Other | Parkinson's disease patients, multiple system atrophy patients, progressive supranuclear palsy |
Primary outcome
Concentration of oligomeric alpha-synuclein in cerebrospinal fluid
Time frame: at day 0 (inclusion) and one year after inclusion
4 secondary outcomes
Total alpha-synuclein concentration in CSF, oligomeric/total alpha-synuclein ratio in CSF
Time frame: At inclusion (Day 0) and one year after inclusion
Oligomeric and total alpha-synuclein concentration in plasma, oligomeric/total alpha-synuclein ratio in plasma
Time frame: At inclusion (Day 0) and one year after inclusion
Alpha-synuclein levels in relation to disease severity and progression, disease duration and age
Time frame: At inclusion (Day 0) and one year after inclusion
Variation of alpha-synuclein levels between first and second sampling
Time frame: At inclusion (Day 0) and one year after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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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.
Wassilios MEISSNER, Pr contact
Wassilios MEISSNER, Pr principal investigator
University Hospital, Bordeaux
Rodolphe THIEBAUT, MD study chair
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinsonian Syndromes and Parkinson's Disease, run by University Hospital, Bordeaux at 3 sites 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 9 inclusion and 8 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Wassilios MEISSNER, Pr (wassilios.meissner@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of oligomeric alpha-synuclein in cerebrospinal fluid (time frame: at day 0 (inclusion) and one year after inclusion). 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 31 Mar 2022.