Parkinson's Disease With LRRK2 MutationINFLAPARKNCT02319382
Measure of Microglial Activation in the Brain of Parkinson Disease Patients With PET
A study testing PET with the tracer 18F-DPA-714, PET with the tracer 11C-PE2I and MRI in people with Parkinson's Disease With LRRK2 Mutation and Healthy Controls, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in the neurodegenerative process of Parkinson's disease (PD). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease With LRRK2 Mutation, Healthy Controls, Parkinson's Disease Without LRRK2 Mutation
- What is being tested?
- PET with the tracer 18F-DPA-714, PET with the tracer 11C-PE2I and MRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Dec 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all subjects:
- The subject is an out-patient aged 18 years or above Active affiliation to national health insurance system Signed informed consent to participate in the study
- Additional criteria depending on the group under study:
- Group 1:
- Parkinson disease diagnosed for less than 18 months and no treatment Age at disease over 40 years
- Group 2:
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- Disease Parkinson diagnosed for less than 36 months and treated by L-Dopa or /and dopaminergic agonist No motor fluctuation Age at disease over 40 years
- Group 3:
- Parkinson disease diagnosed for more than 3 years Age at disease over 40 years Motor fluctuations for more than 6 months (dyskinesia or wearing off )
- Group 4:
- Parkinson disease LRRK2 mutation proved by genetic analysis
- Group 5:
- LRRK2 mutation proved by genetic analysis No evidence of Parkinson disease attested by a Unified Parkinson's Disease Rating Scale (UPDRS) score of 0 or1
- Group 6:
- No evidence of Parkinson disease attested by a UPDRS score of 0 or1
Who cannot join
- For all subjects:
- Contraindication for MRI Anti-inflammation treatment for more 50 days during previous year or for more 7 days during previous month Pregnancy or lactating Legal incapacity or limited legal capacity Beneficiary of AME
- Additional criteria depending on the group under study:
- Group 1:
- Atypical parkinsonism Other neurological diseases or known brain lesion
- Group 2:
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- Atypical parkinsonian syndrome
- Group 3:
- Atypical parkinsonian syndrome Resistance to treatment (benefit of treatment estimated to less than 30%) Other neurological diseases or known brain lesion
- Groups 4 and 5:
- Other neurological diseases or known brain lesion
- Group 6:
- Previous neurological or psychiatry diseases or known brain lesion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Orsay Hospital
Orsay, 91401
Philippe REMY, MD PhD, (0)1.69.86.77.27 ext. +33, neuro-philippe.remy@hmn.aphp.fr
Sonia LAVISSE, PhD, (0)1.69.86.78.91 ext. +33, sonia.lavisse@cea.fr
About this study
Official title: High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in the neurodegenerative process of Parkinson's disease (PD). It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however hard to evidence microglial activation in vivo, especially in the substantia nigra: first, the investigators need very high resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results.
18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to explore the topography and intensity of microglial activation in several different groups of PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients ("honeymoon") (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a new generation tomography having a very high resolution.
This study might reveal significant neuroinflammatory process in the midbrain of PD patients and will determine if such process is present in both sporadic and genetic forms of PD. The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.
- Conditions
- Parkinson's Disease With LRRK2 Mutation, Healthy Controls, Parkinson's Disease Without LRRK2 Mutation
- Being tested
- PET with the tracer 18F-DPA-714, PET with the tracer 11C-PE2I, MRI
- Keywords
- Parkinson Disease, [18F]DPA-714, Positron emission tomography (PET), Neuroinflammation
- Medical subject headings
- Parkinson Disease, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET with the tracer 18F-DPA-714Radiation
PET with the tracer 11C-PE2IRadiation
MRIOther
Magnetic field
| Study group | Role | What they receive |
|---|---|---|
| 2 markers: 18F-DPA-714 and 11C-PE2I | Experimental | PET with the tracer [18F]DPA-714 and second PET with the tracer [11C]-PE2I. [18F]DPA-714 is a new marker. It allows the macroscopic visualization of active microglia in the brain. [11C]-PE2I allow measures dopaminergic neuronal loss. Receives: Radiation: PET with the tracer 18F-DPA-714; Radiation: PET with the tracer 11C-PE2I; Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulation of [18F]DPA-714 in the midbrain assessed through PET
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease With LRRK2 MutationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- France Parkinson Association
- Responsible party
- Sponsor
- Investigators
- Philippe REMY, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319382
- Sponsor's protocol ID
- P091202
- Acronym
- INFLAPARK
- Status last verified
- Jul 2015
- First submitted
- 18 Nov 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peyronneau MA, Kuhnast B, Nguyen DL, Jego B, Sayet G, Caille F, Lavisse S, Gervais P, Stankoff B, Sarazin M, Remy P, Bouilleret V, Leroy C, Bottlaender M. [18F]DPA-714: Effect of co-medications, age, sex, BMI and TSPO polymorphism on the human plasma input function. Eur J Nucl Med Mol Imaging. 2023 Sep;50(11):3251-3264. doi: 10.1007/s00259-023-06286-1. Epub 2023 Jun 9.
PubMed 37291448Ricigliano VAG, Louapre C, Poirion E, Colombi A, Yazdan Panah A, Lazzarotto A, Morena E, Martin E, Bottlaender M, Bodini B, Seilhean D, Stankoff B. Imaging Characteristics of Choroid Plexuses in Presymptomatic Multiple Sclerosis: A Retrospective Study. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 13;9(6):e200026. doi: 10.1212/NXI.0000000000200026. Print 2022 Nov.
PubMed 36229188Lavisse S, Goutal S, Wimberley C, Tonietto M, Bottlaender M, Gervais P, Kuhnast B, Peyronneau MA, Barret O, Lagarde J, Sarazin M, Hantraye P, Thiriez C, Remy P. Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging. Parkinsonism Relat Disord. 2021 Jan;82:29-36. doi: 10.1016/j.parkreldis.2020.11.011. Epub 2020 Nov 17.
PubMed 33242662
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714
- ClinicalTrials.gov ID
- NCT02319382
- Acronym / sponsor ID
- INFLAPARK / P091202
- Conditions
- Parkinson's Disease With LRRK2 Mutation, Healthy Controls, Parkinson's Disease Without LRRK2 Mutation
- Keywords
- Parkinson Disease, [18F]DPA-714, Positron emission tomography (PET), Neuroinflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- France Parkinson Association
- Study start
- Jun 2012
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 18 Dec 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.
There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in the neurodegenerative process of Parkinson's disease (PD). It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels the progressive dopaminergic neurodegeneration. It is however hard to evidence microglial activation in vivo, especially in the substantia nigra: first, the investigators need very high resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results.
18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to explore the topography and intensity of microglial activation in several different groups of PD patients: 1) de novo, drug-naïve subjects (n = 6); 2) non-fluctuating treated patients ("honeymoon") (n = 10); 3) advanced drug-responsive patients motor fluctuations (wearing-off or dyskinesia) (n = 6); 4) patients with LRRK2 gene mutation (n = 6); and 5) related to healthy patients carriers of the mutation LRRK2(n = 6). PET imaging will be performed with a new generation tomography having a very high resolution.
This study might reveal significant neuroinflammatory process in the midbrain of PD patients and will determine if such process is present in both sporadic and genetic forms of PD. The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 markers: 18F-DPA-714 and 11C-PE2I | Experimental | Radiation: PET with the tracer 18F-DPA-714, Radiation: PET with the tracer 11C-PE2I, Other: MRIPET with the tracer [18F]DPA-714 and second PET with the tracer [11C]-PE2I. [18F]DPA-714 is a new marker. It allows the macroscopic visualization of active microglia in the brain. [11C]-PE2I allow measures dopaminergic neuronal loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The subject is an out-patient aged 18 years or above Active affiliation to national health insurance system Signed informed consent to participate in the study
- Parkinson disease diagnosed for less than 18 months and no treatment Age at disease over 40 years
- Disease Parkinson diagnosed for less than 36 months and treated by L-Dopa or /and dopaminergic agonist No motor fluctuation Age at disease over 40 years
- Parkinson disease diagnosed for more than 3 years Age at disease over 40 years Motor fluctuations for more than 6 months (dyskinesia or wearing off )
- Parkinson disease LRRK2 mutation proved by genetic analysis
Key exclusion criteria (13 listed)
- Contraindication for MRI Anti-inflammation treatment for more 50 days during previous year or for more 7 days during previous month Pregnancy or lactating Legal incapacity or limited legal capacity Beneficiary of AME
- Atypical parkinsonism Other neurological diseases or known brain lesion
- Atypical parkinsonian syndrome
- Atypical parkinsonian syndrome Resistance to treatment (benefit of treatment estimated to less than 30%) Other neurological diseases or known brain lesion
- Other neurological diseases or known brain lesion
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 |
|---|---|---|
| PET with the tracer 18F-DPA-714 | Radiation | 2 markers: 18F-DPA-714 and 11C-PE2I |
| PET with the tracer 11C-PE2I | Radiation | 2 markers: 18F-DPA-714 and 11C-PE2I |
| MRIMagnetic field | Other | 2 markers: 18F-DPA-714 and 11C-PE2I |
Primary outcome
Accumulation of [18F]DPA-714 in the midbrain assessed through PET
Time frame: Inclusion visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- Derived from this study: PubMed 37291448Peyronneau MA, Kuhnast B, Nguyen DL, Jego B, Sayet G, Caille F, Lavisse S, Gervais P, Stankoff B, Sarazin M, Remy P, Bouilleret V, Leroy C, Bottlaender M. [18F]DPA-714: Effect of co-medications, age, sex, BMI and TSPO polymorphism on the human plasma input function. Eur J Nucl Med Mol Imaging. 2023 Sep;50(11):3251-3264. doi: 10.1007/s00259-023-06286-1. Epub 2023 Jun 9.
- Derived from this study: PubMed 36229188Ricigliano VAG, Louapre C, Poirion E, Colombi A, Yazdan Panah A, Lazzarotto A, Morena E, Martin E, Bottlaender M, Bodini B, Seilhean D, Stankoff B. Imaging Characteristics of Choroid Plexuses in Presymptomatic Multiple Sclerosis: A Retrospective Study. Neurol Neuroimmunol Neuroinflamm. 2022 Oct 13;9(6):e200026. doi: 10.1212/NXI.0000000000200026. Print 2022 Nov.
- Derived from this study: PubMed 33242662Lavisse S, Goutal S, Wimberley C, Tonietto M, Bottlaender M, Gervais P, Kuhnast B, Peyronneau MA, Barret O, Lagarde J, Sarazin M, Hantraye P, Thiriez C, Remy P. Increased microglial activation in patients with Parkinson disease using [18F]-DPA714 TSPO PET imaging. Parkinsonism Relat Disord. 2021 Jan;82:29-36. doi: 10.1016/j.parkreldis.2020.11.011. Epub 2020 Nov 17.
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.
Philippe REMY, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET with the tracer 18F-DPA-714, PET with the tracer 11C-PE2I and MRI in people with Parkinson's Disease With LRRK2 Mutation and Healthy Controls, run by Assistance Publique - Hôpitaux de Paris 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 15 inclusion and 13 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 14 Jul 2015. 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 Philippe REMY, MD, PhD ((0)1.69.86.77.27 ext. +33, neuro-philippe.remy@hmn.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accumulation of [18F]DPA-714 in the midbrain assessed through PET (time frame: Inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319382, which also lists 3 linked publications.
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 14 Jul 2015.