Ongoing analyses and related projects

In addition to its specific objectives, the NS-PARK cohort aims to provide to the scientific community a high quality data set that can be used to answer scientific questions on Parkinson's disease. Thus, researchers internal or external to NS-PARK network can submit projects on the cohort. All analyses performed on NS-PARK cohort data received the agreement of the cohort Scientific committee and the required regulatory authorizations, without which the access to the data can not be permitted. The data transfer to the requesting researcher is done in a strict compliance with confidentiality rules (anonymized data).

List of ongoing analyses

Synopsis

Parkinson's disease is a common, complex and disabling neurodegenerative disease with an increasing personal, societal and financial burden. The PD patients population is highly heterogenous, with multiple patterns of disease progression. The underlying biology of the disease, the phenotypic variation and the genetic risk profile of patients must be explored for the implementation of personalized therapeutic interventions.

In 2018, the NS-PARK netork was selected in the exceptionnal call for proposals of the France Parkinson association to complement the NS-PARK cohort with a biocollection and associate a patient stratification project. The project relies on the clinical cohort sponsored by Inserm, on the expertise of the NS-PARK clinical research network, the Parkinson's disease genetics teams (JC Corvol, ICM), epidemiology teams (F Tubach, Pitié Salpêtrière hospital) and artificial intelligence team (S Durrleman, ICM), two preclinical teams (D Devos, Lille; W Meissner ad E Bezard,  Bordeaux) and associates two foreign cohorts for validation (D Grosset, UK; O Monchy, Canada).

The PRECISE-PD project plans to continue the effort of collecting longitudinal clinical data from the cohort and to complete them with: a biobank; data quality control and data management; developement of models for the analysis of disease progression integrating clinical and genetic data; implementation of a pipeline for imaging data; validation of obtained results in independent cohorts (UK and Canada partners).

 

Objective

The main objective of the PRECISE-PD project is to propose a model of Parkinson's disease progression based on the pathophysiological mechanisms.

 

Data life cycle

The processing of the data collected in the NS-PARK cohort is under the responsibility of Inserm, the sponsor of this study. Within the PRECISE-PD project, the life cycle of the data is unchanged.

 

Status

Inclusions in progress

Synopsis

The use de dopaminergic drugs in Parkinson's disease allows a clear improvement of motor and to a lesser extent non-motor symptomes. However, the clinical benefit of L-Dopa decreases after a few years of treatment, leading to the appearance of "off" periodes characterized by blockages and the appearance of dyskinesias. Amantadine, a drug with a mechanism of action that is not yet fully understood, has shown interesting effects on motor symptoms of Parkinson's disease.

Currently, its benefits have been explored primarily in the setting of L-Dopa-induced dyskinesias. A new extended-release formulation was in fact approved in 2017 in the United states for this indication. Few data are available on France regarding the place of amantadine in the therapeutic strategy for PD patients. A recent study of a cohort of approwimately 700 French patients with PD shwoed that amantadine was used in 9% of patients, and that its use was associated with the presence of dyskinesias in patients diagnosed for a mean of 7 years. The small number of patiens exposed to amantadine in this cohort (about 60) limits the power of the study to explore the potential links with other symptoms of the disease, especially axial or non-motor symptoms such as fatigue or apathy.  Furthermore, epidemiological and pharmacological studies concerning the effect of amantadine on impulse control disorders are inconsistent. In clinical trials, the value of amantadine has been studied mainly in dyskinesias.

This study would provide information on the prevalence and conditions of use of amantadine in France, and would study the association between the use of this drug and other symptoms that  have nt yet been studies in clinical trials. 

 

Objective 

The primary objective of this study will be to determine the prevalence of amantadine exposure among parkinsonian patients included in the NS-PARK cohort and to characterize their clinical profile to unexposed parkinsonians. The secondary objective will be to characterize the disease progression profile according to amantadine expose status.

 

Data life cycle

The data analyzed in this project are extracted from the NS-PARK cohort by the Center of pharmaco-epidemiology of the Public Health Department of the AP-HP (Pitié Salpêtrière Hospital, statistical team of the cohort), and analyzed under the control of the leader and sponsor, Inserm, by the teams affiliated to the research project.

 

Status

Data analysis in progress

Synopsis

Postural disorders combine static alterations and disabling axial motor symptoms in patients with Parkinson's disease. The most commin are camptocormia, latero-deviation (Pisa syndrome) and antecolis. They can be isolated or associated. They are responsible for impairment of activities of daily living and can cause falls. Several risks factors have been identified in the occurrence of these postural disorders such as gender, age, duration and stage of the disease, phenotype and dopa equivalent dose.Thus, older men with a longer duration of disease and more severe symptoms, predominant bradykinesia and rigidity and a higher dose of dopa equivalent dose could develop postural disorders. Other studies have also reported poorer response to levodopa as an associated factors. Patients with postural disorders may have fewer motor complications (motor fluctuation and dyskinesias) than PD patients without postural disorders. This study will evaluate the existence of a possible association between postural disorders and motor complications in PD patients using the NS-PARK cohort. This will be the first epidemiological study to evaluate a possible positive or negative association between postural disorders and motor complications in Parkinson's disease.  It should provide information about a possible particular phenotype of Parkinson's disease (Parkinson's disease with postural deformity).

 

Objective

The main objective of this study is to identify a possible association between the presence of a postural disorder (whatever it is) and the presence of motor complications (motor fluctuations and/or dyskinesias) in patients with PD.

 

Data life cycle

The data analyzed in this project are extracted from the NS-PARK cohort by the Center of pharmaco-epidemiology of the Public Health Department of the AP-HP (Pitié Salpêtrière Hospital, statistical team of the cohort), and analyzed under the control of the leader and sponsor, Inserm, by the teams affiliated to the research project.

 

Status

Analysis in progress

Synopsis

The Movement Disorders Society has developed the MDS-NMS scale to assess the non-motor symptoms of Parkinson's disease. The original version of the scale was created in English and it is now necessary to translate and validate this scale in different languages so that it can be used internationally. This project will allow the official validation of the French version of the MDS-NMS scale and thus its future use for the evaluation of non-motor symptoms of Parkinson's disease patients.

 

Objective

Validate the French version of the MDS-NMS scale

 

Data life cycle

The processing of the data collected in the NS-PARK cohort is under the responsibility of INSERM, the promoter of this study. Within the framework of this project, the life cycle of the data is the same as that of the cohort data, with the addition of a recipient of the pseudonymized data of the MDS-NMS scale: the Movement Disorders Society (USA). This international foundation is specialized in movement disorders. It will be in charge of analyzing these data to allow the validation of the scale in French.

 

Status

Will start soon

Synopsis

The strategy for initiating dopaminergic therapy in Parkinson's disease (PD), has been a controversial issue for decades. After a period in which dopamine agonists were favored to delay motor complications, the current trend is to return to levodopa as first-line treatment to avoid the undesirable effects of agonists (drowsiness, behavioral disorders). However, the HAS (Haute Autorité de Santé - High Health Autority) still recommends the use of dopamine agonists before the age of 65 and levodopa after age 65 for the initiation of PD treatment. 

In the late stage of the disease, little is known about the therapeutic management of PD, particularly in elderly patients with cognitive impairment, as these patients are poorly represented in clinical studies and make fewer visits to the Parkinson Expert Centers. However, epidemiological factors such as the increasing prevalence of older patients and the predicted exponential increase in the prevalence of PD in the next two decades bring the increased risk of PD reaching older patients and/or an increase in the predicted duration of the disease. The therapeutic management of these patients remains to be defined. 
The combinations of treatments used, their sequential order, depending on the age of the Parkinsonian patients and the various non-motor symptoms they present, are not the subject of specific recommendations and remain unknown for the moment, both in the early and late stages of the disease.
This study therefore proposes to study the trajectories adopted in the treatment of PD at two stages of the disease, early and late.

 

Objective

The main objective of this study is to describe the different drug combinations used by the neurologists of the Parkinson Expert Centers, in early and late stage PD patients

 

Data life cycle

The data analyzed in this project are extracted from the NS-PARK cohort by the Center of pharmaco-epidemiological of the Publi Health Department of the AP-HP (Pitié Salpêtrière Hospital, statistical team of the cohort), and analyzed under the control of the leader and sponsor, INSERM, by the teams affiliated to the research project.

 

Status

Analysis in progress

 

Synopsis

The NS-PARK cohort if one of the 10 successful projects selected by the Ministry of Health for the Health Data Hub program (https://solidarites-sante.gouv.fr/actualites/presse/communiques-de-presse/article/cp-annonce-des-10-laureats-de-l-appel-a-projet-du-health-data-hub).

The individual trajectory of patients with Parkinson's disease is currently not predictable. It depends on factors that are inherent to the disease (severity, genetic factors) and on the frequent comorbidities in this elderly population. This pilot project will make it possible to study the comorbidities associated with Parkinson's disease, by linking the data collection in the cojort to that recorded by the National Health Data System (SNDS ; https://www.snds.gouv.fr/SNDS/Accueil).

The SNDS was created by the law on the modernisation of the healthcare system of January 26, 2016, and aims in particular to promote studies, research, or evaluation in health that are of public interest. By pairing information collected from patients with information of the SNDS, researches on the studied pathology will be deepened (for example, the study of disorders associated with the disease, frequently observed in the patient population).

 

Objective

The objective of the project is to propose a predictive tool of individual trajectories to neurologists, in order to implement appropriate preventive measures.

 

Data life cycle

The processing of the data collected in the NS-PARK cohort is under the responsibility of Inserm, the sponsor of this study. Within the project NS-PARK-HDH, the life cycle of data is the same as for the cohort data, with the addition of a data recipient: the Health Data Hub. This data warehouse, initiated by the Ministry of Health, will host a selection of coded data from the cohort, linked to a selection of data from the SNDS.

 

Status

Project in preparation

Ancillary studies

Collaborations

In preparation.  

Information for patients:

You are participating to the NS-PARK cohort and you would like additional information on the processing and use of your data, please see the dedicated section Your Data

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Updated on 20 February 2023