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

July 13, 2015 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2 markers: 18F-DPA-714 and 11C-PE2I
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.
Radiation: PET with the tracer 18F-DPA-714
Radiation: PET with the tracer 11C-PE2I
Other: MRI
Magnetic field

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Accumulation of [18F]DPA-714 in the midbrain assessed through PET
Time Frame: Inclusion visit
Inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

France Parkinson Association

Investigators

  • Principal Investigator: Philippe REMY, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 13, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Estimate)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 13, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P091202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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