Identification of Risk Factors Parkinson's Disease by Con... | NCT03536104

Studies
Identification of Risk Factors Parkinson's Disease by Convergence Strategy

NCT03536104

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 3, 2025Actual

Enrollment

2,220Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-A00219-46	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2009Actual

Primary Completion Date

Nov 19, 2024Actual

Completion Date

Nov 19, 2024Actual

First Submitted Date

May 14, 2018

First Submission Date that Met QC Criteria

May 14, 2018

First Posted Date

May 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2025

Last Update Posted Date

Dec 3, 2025Actual

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,220Actual

Label	Type	Description	Intervention Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases