Identification of Risk Factors Parkinson's Disease by Convergence Strategy

NCT ID: NCT03536104

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-25
• Study Completion Date: 2024-11-19

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.

Conditions

Parkinson Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Controls

This group will include "healthy" person.

No interventions assigned to this group

Parkinson's patient

This group will include Parkinsonian patients

No interventions assigned to this group

patients with a related disease.

This group will include patients with a related disease.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain DESTEE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Roger Salengro, CHRU de Lille

Lille, , France

Countries

France

Other Identifiers

2008-A00219-46

Identifier Type: OTHER

Identifier Source: secondary_id

2008_0811

Identifier Type: -

Identifier Source: org_study_id