NCT02816645

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

13 active sites

Status
unknown

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

Study Start

First participant enrolled

August 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

4.9 years

First QC Date

June 20, 2016

Last Update Submit

March 8, 2019

Conditions

Parkinson's Disease

Keywords

Parkinson's DiseaseBiomarkerIronR2*MRIPatientsUK Parkinson's Disease Society Brain Bank

Outcome Measures

Primary Outcomes (1)

  • Change from baseline cerebral R2*

    Change from baseline cerebral R2\* quantification at 1 year in three regions of interest (Substantia Nigra, Ventral Tegmental Area and Putamen).

    at 1 year

Secondary Outcomes (12)

  • Change from baseline Parkinson's disease clinical symptoms

    at 1 year

  • Change from baseline severity of Parkinson's disease

    at 1 year

  • Change from baseline activities of daily living

    at 1 year

  • Change from baseline freezing

    at 1 year

  • change from baseline cognitive function

    at 1 year

  • +7 more secondary outcomes

Study Arms (4)

<5 years

EXPERIMENTAL

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)

Between 5 and 10 years

EXPERIMENTAL

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)

Between 10 and 15 years

EXPERIMENTAL

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)

> 15 years

EXPERIMENTAL

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)

Interventions

Magnetic Resonance Imaging (MRI)PROCEDURE
<5 years> 15 yearsBetween 10 and 15 yearsBetween 5 and 10 years

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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,…).
  • 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,…).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Chu Pellegrin

Bordeaux, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Chu Grenoble

Grenoble, France

RECRUITING

Chu Lille

Lille, France

RECRUITING

Chu Dupuytren

Limoges, France

RECRUITING

Hôpital neurologique Pierre Wertheimer

Lyon, France

RECRUITING

Chu Montpellier

Montpellier, France

RECRUITING

Chu Nancy

Nancy, France

RECRUITING

CHU Pitié Salpétrière

Paris, France

RECRUITING

Hôpital Henri Mondor

Paris, France

RECRUITING

Chu Poitiers

Potiers, France

RECRUITING

Chu Reims

Reims, France

RECRUITING

Chu Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Anna MARQUES

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 28, 2016

Study Start

August 1, 2015

Primary Completion

June 30, 2020

Study Completion

February 15, 2021

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations

FR(13)