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

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ClinicalTrials.gov Identifier: NCT03536104
Recruitment Status : Recruiting
First Posted : May 24, 2018
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date May 14, 2018
First Posted Date May 24, 2018
Last Update Posted Date August 25, 2020
Actual Study Start Date March 25, 2009
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 14, 2018)
Significant variations in the frequencies of gene polymorphisms and the risk of developing Parkinson's disease [ Time Frame: through study completion, an average of 10 years ]
the frequency is measured according to biological and environmental variables modulating the risk of developing Parkinson's disease.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Risk Factors Parkinson's Disease by Convergence Strategy
Official Title Identification of Risk Factors Parkinson's Disease by Convergence Strategy
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum, plasma, CSF
Sampling Method Probability Sample
Study Population Patients with Parkinson Disease compared to subjects at risk to develop Parkinson Disease and healthy controls
Condition Parkinson Disease
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 14, 2018)
2220
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Alain DESTEE, MD,PhD alain.destee@chru-lille.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03536104
Other Study ID Numbers 2008_0811
2008-A00219-46 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Alain DESTEE, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date August 2020