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Parkinson DiseasePhase 2GLIAPARKNCT03230526

Identification of a Biomarker Predictive of Evolution of Parkinson Disease

A Phase 2 study testing [18F]DPA-714 PET scan in people with Parkinson Disease, run by Nantes University Hospital at 4 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 40 to 67 years
Conditions the study is for
Parkinson Disease
What is being tested?
[18F]DPA-714 PET scan
How many people
31 participants
Where
4 sitesFrance
Study dates
16 Apr 2018to 6 May 2024
Phase
Phase 2
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 40 to 67 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients having a Parkinson's disease diagnosed according to the criteria UKPDSBB.
  • Diagnosis done less than three years before the date the inclusion.
  • 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.

Who cannot join

  • Pregnant woman
  • Minor
  • Adult protected by the law
  • Contraindication to PET-scan
  • Contraindication to brain MRI
  • History of inflammatory or dysimmune chronic disease
Show all 13Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

France4 sites

  • CHU de Nantes

    Nantes

  • Centre Eugène Marquis

    Rennes

  • CHU de Rennes

    Rennes

  • CHU de Tours

    Tours

Other trials in France

About this study

Official title: Brain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution?

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).

Read the detailed description

The Parkinson's disease ( MP) is a frequent but heterogeneous neurodegenerative disease in term of clinical presentation(display) and evolutionary profile. The therapeutic coverage(care) of the patients would thus be personalized Such an approach remains still in its infancy in 2017. Better know the factors which determine the evolutionary clinical subcategories is a major question of the current researches on the Parkinson disease. Nigrostriaial inflammation is an interesting candidate. Microglia activation is closely associated with the degenerative process.

Development of the molecular imaging allows to study nigrostriatal inflammation in vivo in human by positron emission tomography (PET) by using the radiotracer of the protein of translocation of 18KDa ( TSPO), considered as a marker of microglia activation Some studies showed an increase of the inflammation in the striatum and in the substantia nigra, the sites of the dopaminergic degeneration (The lesional core of the Parkinson disease is the damage of the dopaminergic nigrostriatale way). However data remain rare and concern small number of patients. Some data are inconsistent because of problems of specificity of the ligands used and variation between populations of studied patients (duration of disease evolution).

In this study, investigators suggest studying by imaging TEP using a ligand new of the TSPO, [18F]DPA-714, microglial brain activation in the early stage of the Parkinson disease and determine wether it is predictive of speed of disease progression.

Being tested
[18F]DPA-714 PET scan
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 months

Secondary outcomes (70)

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

    Will be estimated by imaging PET with [18F]DPA-714

    Measured: 24 months

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

    The equivalent dose of cumulative L-Dopa

    Measured: baseline

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

    The equivalent dose of cumulative L-Dopa

    Measured: 18 months

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

    The equivalent dose of cumulative L-Dopa

    Measured: 24 months

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

    MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)

    Measured: Baseline

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

    MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)

    Measured: 18 Months

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

    MDS-UPDRS scale (part III "OFF" - Part III "ON" and part II)

    Measured: 24 Months

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

    MDS-UPDRS scale (part IV)

    Measured: baseline

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

    MDS-UPDRS scale (part IV)

    Measured: 18 months

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

    MDS-UPDRS scale (part IV)

    Measured: 24 months

  11. Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)

    QUIP RS

    Measured: baseline

  12. Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)

    QUIP RS

    Measured: 18 months

  13. Evaluate the link between the level of striatal microglial activation at inclusion and:the severity of dopaminergic symptoms (non-motors)

    QUIP RS

    Measured: 24 months

  14. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)

    MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)

    Measured: baseline

  15. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)

    MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)

    Measured: 18 months

  16. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)

    MDS-UPDRS scale (part III ON : 3.1 ; 3.2 ; 3.9 to 3.13)

    Measured: 24 months

  17. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)

    MDS-UPDRS scale (part II : 2.13 and part III : 3.11)

    Measured: baseline

  18. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)

    MDS-UPDRS scale (part II : 2.13 and part III : 3.11)

    Measured: 18 months

  19. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (motor)

    MDS-UPDRS scale (part II : 2.13 and part III : 3.11)

    Measured: 24 months

  20. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MDS-UPDRS scale (part I)

    Measured: Baseline

  21. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MDS-UPDRS scale (part I)

    Measured: 18 months

  22. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MDS-UPDRS scale (part I)

    Measured: 24 months

  23. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    NMS SCALE

    Measured: baseline

  24. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    NMS SCALE

    Measured: 18 months

  25. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    NMS SCALE

    Measured: 24 months

  26. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Scopa-Aut Score

    Measured: baseline

  27. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Scopa-Aut Score

    Measured: 18 months

  28. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Scopa-Aut Score

    Measured: 24 months

  29. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Evaluation of constipation according to Rome III criteria

    Measured: Baseline

  30. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Evaluation of constipation according to Rome III criteria

    Measured: 18 months

  31. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Evaluation of constipation according to Rome III criteria

    Measured: 24 months

  32. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Detection of hypotension

    Measured: Baseline

  33. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Detection of hypotension

    Measured: 18 months

  34. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Detection of hypotension

    Measured: 24 months

  35. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders

    Measured: Baseline

  36. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders

    Measured: 18 months

  37. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Detection of paradoxical sleep disorder, according to the questionnaire for the detection of REM sleep disorders

    Measured: 24 months

  38. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Epworth's Sleepiness Scale

    Measured: Baseline

  39. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Epworth's Sleepiness Scale

    Measured: 18 Months

  40. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Epworth's Sleepiness Scale

    Measured: 24 Months

  41. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    UPSIT test

    Measured: baseline

  42. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    UPSIT test

    Measured: 24 Months

  43. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MoCA score

    Measured: Baseline

  44. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MoCA score

    Measured: 18 Months

  45. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MoCA score

    Measured: 24 Months

  46. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MATTIS scale

    Measured: Baseline

  47. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MATTIS scale

    Measured: 18 Months

  48. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    MATTIS scale

    Measured: 24 Months

  49. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Anxiety symptoms assessed using Beck's anxiety inventory

    Measured: Baseline

  50. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Anxiety symptoms assessed using Beck's anxiety inventory

    Measured: 18 months

  51. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Anxiety symptoms assessed using Beck's anxiety inventory

    Measured: 24 Months

  52. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Symptoms of depression assessed using the Beck Depression

    Measured: Baseline

  53. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Symptoms of depression assessed using the Beck Depression

    Measured: 18 Months

  54. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of symptoms considered mainly non-dopaminergic (non-motor)

    Symptoms of depression assessed using the Beck Depression

    Measured: 24 Months

  55. Evaluate the relation between the level of striatal microglial activation at inclusion and the severity of dopaminergic denervation at baseline (DaTscan initial)

    Dopaminergic denervation at inclusion will be measured by the binding potential (BP) of ioflupane (123I-FP-CIT) by regions of interest in the caudate and putamen of the striatum

    Measured: Baseline

  56. Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57

    MDS-UPDRS scale

    Measured: 24 Months

  57. Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57

    QUIP questionnaire

    Measured: 24 Months

  58. Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57

    NMS questionnaire

    Measured: 24 Months

  59. Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57

    Scopa-Aut Score

    Measured: 24 Months

  60. Evaluate the link between the level of microglial activation in the black substance and outcome 3 to outcome 57

    Rome III criteria

    Measured: 24 Months

  61. Evaluate the link between the level of striatal microglial activation and the level of activation in other brain regions (black substance, bridge and cortex)

    The level of cortical microglial activation measured by fixation of the radioligand 18F-DPA-714, on some volumes of interest in the brain

    Measured: 24 months

  62. Assess the relationship between the level of microglial activation in the extra-striatal cortical (cortex and brain stem) regions and the presence of non-motor and axial motor symptoms.

    Neurologic Evaluation

    Measured: baseline

  63. Assess the relationship between the level of microglial activation in the extra-striatal cortical (cortex and brain stem) regions and the presence of non-motor and axial motor symptoms.

    Neurologic Evaluation

    Measured: 18 months

  64. Assess the relationship between the level of microglial activation in the extra-striatal cortical (cortex and brain stem) regions and the presence of non-motor and axial motor symptoms.

    Neurologic Evaluation

    Measured: 24 months

  65. Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation

    The serum levels of 13 cytokines will be analyzed

    Measured: Baseline

  66. Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation Evaluate the relationship between the level of nigrostriatal microglial activation

    The serum levels of 13 cytokines will be analyzed

    Measured: 18 months

  67. Evaluate the link between the level of nigrostriatal microglial activation and the serum level of biological markers of inflammation

    The serum levels of 13 cytokines will be analyzed

    Measured: 24 months

  68. Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months

    Measurement of serum uric acid

    Measured: Baseline

  69. Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months

    Measurement of serum uric acid

    Measured: 18 months

  70. Evaluate the relationship between the level of nigrostriatal microglial activation and the serum uric acid level at 0, 18 and 36 months

    Measurement of serum uric acid

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2017
  2. Study start16 Apr 2018
  3. Primary completion6 May 2024 (estimated)
  4. Study completion6 May 2024 (estimated)

Resources

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 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03230526
Sponsor's protocol ID
RC17_0012
Other IDs
2017-000411-16, 2017
Acronym
GLIAPARK
Status last verified
Apr 2024
First submitted
18 Jul 2017
Last updated
25 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [18F]DPA-714 PET scan in people with Parkinson Disease, run by Nantes University Hospital at 4 sites 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 7 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 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coefficient of correlation between level of microglial striatal activation and the And the dopaminergic denervation kinetics (time frame: 24 months). 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 NCT03230526.

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 25 Apr 2024.

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