Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT03536104
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03536104
Study Brief:
Protocol Section:
NCT03536104