Identification of Risk Factors Parkinson's Disease by Convergence Strategy

Parkinson Disease Clinical Trial

— CONVERGENCE  

Official title:

Identification of Risk Factors Parkinson's Disease by Convergence Strategy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03536104
• Other study ID #: 2008_0811
• Secondary ID: 2008-A00219-46
• Status: Recruiting
• Start date: March 25, 2009
• Est. completion date: March 2024

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: Alain DESTEE, MD,PhD
• Email: alain.destee[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2220
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHRU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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