NCT03230526

Brief Summary

Phase II, Open-labeled, Prospective, Multi-center study of assessing the link between microglial activation and dopaminergic denervation kinetics in the early stage of Parkinson disease, by using the imaging of \[18F\]DPA-714 a new ligand of Translocator Protein-18 kDa (TSPO) by Positron Emission Tomography (PET).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_2 parkinson-disease

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

April 16, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

6.1 years

First QC Date

July 18, 2017

Last Update Submit

April 23, 2024

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Coefficient of correlation between level of microglial striatal activation and the And the dopaminergic denervation kinetics

    Coefficient of correlation between the striatal microglial activation level measured by PET imaging \[binding potential (BP) of 18F-DPA-714 in the striatum\] and dopaminergic denervation kinetics obtained from two 123I-FP-CIT (DaTscan) scans

    24 months

Secondary Outcomes (70)

  • Analyze the relationship between the level of microglial activation in the black substance at the early stage of MP and the dopaminergic denervation kinetics

    24 months

  • Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)

    baseline

  • Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)

    18 months

  • Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)

    24 months

  • Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic symptoms (motors)

    Baseline

  • +65 more secondary outcomes

Interventions

[18F]DPA-714 PET scanDRUG

One PET scan using \[18F\]DPA-714 is done at M2 between two \[123I\]FP-CIT scan (DaTscan) done at M1 and M23. Neuropsychological assessment is done at M0, M18 and M24

Eligibility Criteria

Age40 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having a Parkinson's disease diagnosed according to the criteria UKPDSBB.
  • Patient Age at diagnosis : between 40 and 65 years.
  • Absence of clinical arguments for an associated neurovascular pathology.
  • Written consent obtained.
  • HAB polymorphism in the genotyping of TSPO gene.
  • Brain MRI without following abnormalities: cortical or sub-cortical atrophy or hippocampal atrophy (Scheltens score ≥2), vascular encephalopathy (Fazekas score \> 2, \> 10 microbleed) or showing signs in favour of atypical parkinson syndrome.

You may not qualify if:

  • Pregnant woman
  • Minor
  • Adult protected by the law
  • Contraindication to PET-scan
  • Contraindication to brain MRI
  • History of inflammatory or dysimmune chronic disease
  • History of psychiatric disease or drug addiction
  • History of cognitive disorders (MMS\<26)
  • Hypersensibility to iodine derivates or one of these components
  • Long-term Treatments which can interfere in neuroinflammation process
  • Treatments / substances susceptible to interfere with the 18F-DPA-714
  • TSPO gene Polymorphisms rs6971 corresponding to groups of affinity of low affinity (LAB=Low Affinity Binder) or moderated MAB = Mixed Affinity Binder)
  • Modification of diagnosis of Parkinson disease during follow-up, in particular towards an atypical parkinson-like syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU de Nantes

Nantes, France

Location

Centre Eugène Marquis

Rennes, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Tours

Tours, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 26, 2017

Study Start

April 16, 2018

Primary Completion

May 6, 2024

Study Completion

May 6, 2024

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

FR(4)