Identification of Risk Factors Parkinson's Disease by Convergence Strategy (CONVERGENCE)

Using this convergence approach from a limited group of subjects with non-diseased controls, patients with Parkinson's disease or related diseases, we will be able to limit the number of potential genes of specific susceptibility to Parkinson disease. These genes will then be studied using a case-control genetic epidemiology approach. The risk of developing the disease will then be evaluated according to clinical, biological and environmental variables collected in Parkinson's subjects and healthy controls in the second group of subjects. The specificity of the genetic associations found will be evaluated in subjects with Parkinson's disease.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease

• Study Type: Observational
• Enrollment (Anticipated): 2220

Contacts and Locations

• Study Contact: Name: Alain DESTEE, MD,PhD; Email: alain.destee@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hopital Roger Salengro, CHRU de Lille
    • Principal Investigator: Alain DESTEE, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with Parkinson Disease compared to subjects at risk to develop Parkinson Disease and healthy controls

Description

Inclusion Criteria:

• Inclusion criteria for Parkinson's patients and "related diseases" controls:
• Parkinsonian patients meeting the Gelb criteria
• Patients with other neurodegenerative disease (such as other Parkinson syndrome or synucleopathies) meeting the criteria set out in Appendix 2 (Lewy Bodies dementia, Parkinson's disease with dementia, MultiSystem atrophy, Progressive Supranuclear Paralysis) , Amyotrophic Lateral Sclerosis, Restless Legs Syndrome, Alzheimer's Disease).
• Woman of childbearing age having an effective means of contraception.
• Informed consent signed by the subject or his legal representative.
• For demented subjects coming for consultation or day hospitalization with an accompanying person, signature of the legal representative.

Criteria for inclusion of non-ill controls:

• Absence of rest trembling, bradykinesia and stiffness
• MMSE (Mini Mental State Examination) greater than 25
• Woman of childbearing age having an effective means of contraception.
• subject having signed the informed consent.
• No family history of neurodegenerative disease that started before age 70. These controls will not present any Parkinsonian signs during the clinical evaluation. They may have functional disabilities whose cause is known and unrelated to a neurodegenerative disease with a cognitive function measurement greater than 25 in the MMSE test.

Exclusion Criteria:

• Criteria for non-inclusion of patients:
• Clinical criteria for exclusion of the diseases described
• Participation in another therapeutic trial or in the exclusion period of a previous clinical trial.

Criteria for non-inclusion of non-ill controls:

• Functional discomfort in daily life of unknown cause
• MMSE less than 25
• Participation in another therapeutic trial or in the exclusion period of a previous clinical trial.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Controls; This group will include "healthy" person.
Parkinson's patient; This group will include Parkinsonian patients
patients with a related disease.; This group will include patients with a related disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Significant variations in the frequencies of gene polymorphisms and the risk of developing Parkinson's disease	the frequency is measured according to biological and environmental variables modulating the risk of developing Parkinson's disease.	through study completion, an average of 10 years

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Alain DESTEE, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2009
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 24, 2018

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2008_0811; 2008-A00219-46 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No