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Trial record 40 of 2486 for:    parkinson's

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 : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease
Parkinson Disease

Study Type : Observational
Estimated Enrollment : 2220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identification of Risk Factors Parkinson's Disease by Convergence Strategy
Study Start Date : December 2008
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
serum, plasma, CSF


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with Parkinson Disease compared to subjects at risk to develop Parkinson Disease and healthy controls
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.

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): NCT03536104


Contacts
Contact: Alain DESTEE, MD,PhD alain.destee@chru-lille.fr

Locations
France
Hôpital Roger Salengro, CHRU de Lille Recruiting
Lille, France
Principal Investigator: Alain DESTEE, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Alain DESTEE, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03536104     History of Changes
Other Study ID Numbers: 2008_0811
2008-A00219-46 ( Other Identifier: ID-RCB number, ANSM )
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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