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One-year Follow-up of Iron in Basal Ganglia - R2*: a Biomarker of Parkinson's Disease Progression? (MPI-R2*)

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ClinicalTrials.gov Identifier: NCT02816645
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : June 29, 2016
Sponsor:
Collaborators:
France Parkinson Association
Federation for Brain Research
NS-PARK Network
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
The study of non-invasive and reliable biomarkers to track progression of Parkinson's disease (PD) is essential while disease-modifying treatments are being developed. Many clinical biological or imaging biomarkers have been tested but no "gold standard" has been found as of yet. Among these, Magnetic Resonance Imaging (MRI) relaxometry using R2* measurement (R2* = 1/T2*), which is a validated marker for estimating brain iron concentration, appears to be an attractive technique because its safety, rapidly measured in clinical conditions and its ease to ensure individual longitudinal follow-up. Current data of cross sectional studies of R2*, which have shown an iron increase in Substantia Nigra (SN), led to suppose that it could be a biomarker of disease vulnerability. Recently, the investigators have conducted the first longitudinal follow-up of R2* (1.5 T MRI), which showed a rapid R2* increase in both parts of the SN and in the caudal putamen. We propose, here, a multicenter prospective study of one-year cohort follow-up of R2* variations (ΔR2*) in three regions of interest (ROIs) (the SN, the Ventral Tegmental Area (VTA) and the Putamen) of 160 patients with PD, using a 3 Tesla MRI, to evaluate the potential interest of R2* as a biomarker of disease progression. The variation of R2* (ΔR2*) will be correlated with clinical markers of disease progress, non-motor symptoms. 80 healthy controls subjects will also be included to assess the effect of aging on cerebral physiological iron levels.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Procedure: Magnetic Resonance Imaging (MRI) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: One-year Follow-up of Iron in Basal Ganglia - R2*: a Biomarker of Parkinson's Disease Progression?
Study Start Date : August 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : September 2019

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: <5 years

160 PD patients divided into four subgroups of 40 patients according to disease duration:

  • < 5 years
  • Between 5 and 10 years
  • Between 10 and 15 years
  • > 15 years
Procedure: Magnetic Resonance Imaging (MRI)
Experimental: Between 5 and 10 years

160 PD patients divided into four subgroups of 40 patients according to disease duration:

  • < 5 years
  • Between 5 and 10 years
  • Between 10 and 15 years
  • > 15 years
Procedure: Magnetic Resonance Imaging (MRI)
Experimental: Between 10 and 15 years

160 PD patients divided into four subgroups of 40 patients according to disease duration:

  • < 5 years
  • Between 5 and 10 years
  • Between 10 and 15 years
  • > 15 years
Procedure: Magnetic Resonance Imaging (MRI)
Experimental: > 15 years

160 PD patients divided into four subgroups of 40 patients according to disease duration:

  • < 5 years
  • Between 5 and 10 years
  • Between 10 and 15 years
  • > 15 years
Procedure: Magnetic Resonance Imaging (MRI)



Primary Outcome Measures :
  1. Change from baseline cerebral R2* [ Time Frame: at 1 year ]
    Change from baseline cerebral R2* quantification at 1 year in three regions of interest (Substantia Nigra, Ventral Tegmental Area and Putamen).


Secondary Outcome Measures :
  1. Change from baseline Parkinson's disease clinical symptoms [ Time Frame: at 1 year ]
    - Change from baseline Parkinson's disease clinical symptoms at one year with the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS Score.

  2. Change from baseline severity of Parkinson's disease [ Time Frame: at 1 year ]
    - Change from baseline severity of Parkinson's disease at one year with the HOEHN & YAHR status.

  3. Change from baseline activities of daily living [ Time Frame: at 1 year ]
    - Change from baseline activities of daily living at one year with the SCHWAB & ENGLAND scale.

  4. Change from baseline freezing [ Time Frame: at 1 year ]
    - Change from baseline freezing at one year with the Freezing of Gait Questionnaire (FOG-Q).

  5. change from baseline cognitive function [ Time Frame: at 1 year ]
    - Change from baseline cognitive function at one year with the Montreal Cognitive Assessment (MoCA).

  6. Change from baseline hyper and hypo dopaminergic symptoms scores [ Time Frame: at 1 year ]
    - Change from baseline hyper and hypo dopaminergic symptoms scores at one year with the Ardouin Scale of Behavior in Parkinson's Disease (ASBPD)

  7. Change from baseline sleepiness score [ Time Frame: at 1 year ]
    Change from baseline sleepiness score at one year with the Epworth Sleepiness Scale (ESS).

  8. Change from baseline autonomic functions score [ Time Frame: at 1 year ]
    Change from baseline autonomic functions score at one year with the SCales for Outcomes in Parkinson's disease (SCOPA-AUT).

  9. Change from baseline non-motor symptoms score [ Time Frame: at 1 year ]
    Change from baseline non-motor symptoms score at one year with the Non-Motor symptom assessment Scale for Parkinson's Disease (NMSS).

  10. Change from baseline apathy score [ Time Frame: at 1 year ]
    - Change from baseline apathy score at one year with the Lille Apathy Rating Scale (LARS).

  11. Change from baseline depression score [ Time Frame: at 1 year ]
    - Change from baseline depression score at one year with the Hamilton Rating Scale for Depression (HAM-D).

  12. Change from baseline anxiety score [ Time Frame: at 1 year ]
    - Change from baseline anxiety score at one year with the Hamilton Rating Scale for Anxiety (HAM-A).



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria for PATIENTS :

  • Parkinson's Disease (UK Parkinson's Disease Society Brain Bank Criteria).
  • No Deep Brain Stimulation (DBS).
  • From 40 to 80 years old.

Inclusion criteria for HEALTHY CONTROL SUBJECTS :

- From 40 to 80 years old.

Exclusion criteria for PATIENTS :

  • Dementia (MoCA < 24).
  • Atypical parkinsonism (MSA, PSP, …).
  • Severe current psychiatric or somatic disease.
  • Iron treatments (Desferal® (deferoxamine), Ferriprox® (deferiprone) et Exjade® (deferasirox), Fumafer® (ferrous fumarate), Tardyferon® (ferrous sulfate (II)),…), Ferinject® (ferric carboxymaltose), Venofer® (iron sucrose),…).
  • Contra-indication to MRI (claustrophobia, pace maker,…).

Exclusion criteria for HEALTHY CONTROL SUBJECTS :

  • Neurological disease.
  • Psychiatric or somatic disease.
  • Dementia (MoCA < 24).
  • Iron treatments (Desferal® (deferoxamine), Ferriprox® (deferiprone) et Exjade® (deferasirox), Fumafer® (ferrous fumarate), Tardyferon® (ferrous sulfate (II)),…), Ferinject® (ferric carboxymaltose), Venofer® (iron sucrose),…).
  • Contra-indication to MRI (claustrophobia, pace maker,…).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816645


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Anna MARQUES         
Chu Grenoble Recruiting
Grenoble, France
Chu Lille Recruiting
Lille, France
Chu Dupuytren Recruiting
Limoges, France
Hôpital neurologique Pierre Wertheimer Recruiting
Lyon, France
CHU Pitié Salpétrière Recruiting
Paris, France
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
France Parkinson Association
Federation for Brain Research
NS-PARK Network
Investigators
Principal Investigator: Anna MARQUES University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02816645     History of Changes
Other Study ID Numbers: CHU-0268
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: June 29, 2016
Last Verified: June 2016

Keywords provided by University Hospital, Clermont-Ferrand:
Parkinson's Disease
Biomarker
Iron
R2*
MRI
Patients
UK Parkinson's Disease Society Brain Bank

Additional relevant MeSH terms:
Parkinson Disease
Disease Progression
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Disease Attributes
Pathologic Processes