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Measure of Microglial Activation in the Brain of Parkinson Disease Patients With PET (INFLAPARK)

Primary Purpose

Parkinson's Disease With LRRK2 Mutation, Healthy Controls, Parkinson's Disease Without LRRK2 Mutation

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

PET with the tracer 18F-DPA-714

PET with the tracer 11C-PE2I

MRI

About this trial

This is an interventional basic science trial for Parkinson's Disease With LRRK2 Mutation focused on measuring Parkinson Disease, [18F]DPA-714, Positron emission tomography (PET), Neuroinflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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:

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

Exclusion Criteria:

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:

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

Sites / Locations

Orsay HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2 markers: 18F-DPA-714 and 11C-PE2I

Arm Description

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.

Outcomes

Primary Outcome Measures

Accumulation of [18F]DPA-714 in the midbrain assessed through PET

Secondary Outcome Measures

Full Information

NCT ID

NCT02319382

First Posted

November 18, 2014

Last Updated

July 13, 2015

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

France Parkinson Association

1. Study Identification

Unique Protocol Identification Number

NCT02319382

Brief Title

Measure of Microglial Activation in the Brain of Parkinson Disease Patients With PET

Acronym

INFLAPARK

Official Title

High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

November 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

France Parkinson Association

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

2 markers: 18F-DPA-714 and 11C-PE2I

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

PET with the tracer 18F-DPA-714

Intervention Type

Radiation

Intervention Name(s)

PET with the tracer 11C-PE2I

Intervention Type

Other

Intervention Name(s)

MRI

Intervention Description

Magnetic field

Primary Outcome Measure Information:

Title

Accumulation of [18F]DPA-714 in the midbrain assessed through PET

Time Frame

Inclusion visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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: 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 Exclusion Criteria: 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: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe REMY, MD, PhD

Phone

(0)1.69.86.77.27

Ext

+33

neuro-philippe.remy@hmn.aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Sonia LAVISSE, PhD

Phone

(0)1.69.86.78.91

Ext

+33

sonia.lavisse@cea.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philippe REMY, MD, PhD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orsay Hospital

City

Orsay

ZIP/Postal Code

91401

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe REMY, MD PhD

Phone

(0)1.69.86.77.27

Ext

+33

neuro-philippe.remy@hmn.aphp.fr

First Name & Middle Initial & Last Name & Degree

Sonia LAVISSE, PhD

Phone

(0)1.69.86.78.91

Ext

+33

sonia.lavisse@cea.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

36229188

Citation

Ricigliano 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.

Results Reference

derived

PubMed Identifier

33242662

Citation

Lavisse 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.

Results Reference

derived

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Measure of Microglial Activation in the Brain of Parkinson Disease Patients With PET

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