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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02319382
• Date of registration: 18/11/2014
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Measure of Microglial Activation in the Brain of Parkinson Disease Patients With PET INFLAPARK
• Scientific title: High Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714
• Date of first enrolment: June 2012
• Target sample size: 46
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02319382
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Philippe REMY, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

• Name: Philippe REMY, MD PhD

• Name: Philippe REMY, MD, PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Controls

Parkinson's Disease Without LRRK2 Mutation

Parkinson's Disease With LRRK2 Mutation

Intervention(s)

Radiation: PET with the tracer 18F-DPA-714

Other: MRI

Radiation: PET with the tracer 11C-PE2I

Primary Outcome(s)

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

Secondary ID(s)

P091202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

France Parkinson Association