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:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT05150158
Eligibility Criteria:
Patients with clinically defined or probable PD will need to meet the criteria for the diagnosis of PD (clinically defined or probable) prepared by the Movement Disorder Society (MDS) in 2015 \[Postuma et al, 2015\]. Patients with neurodegenerative parkinsonism will have to meet the published diagnostic criteria for MSA \[Gilman et al, 2008\], PSP \[Höglinger et al, 2017\], DLB \[McKeith et al, 2017\] and CBD \[Armstrong et al, 2013\]. Patients with prodromal PD will have to meet the diagnostic criteria proposed by the MDS for the diagnosis of "probable" prodromal PD if the risk percentage of developing PD\> 80%, or "possible" if the risk percentage of developing PD\> 50 % \[Berg et al, 2015; Heinzel et al, 2019\]. The risk or prodromal factors proposed by the MDS to calculate the probability of prodromal PD include: male sex, exposure to pesticides, exposure to solvents, caffeine intake, smoking habit, familiarity (first degree relative with PD), hyperechogenicity of the substantia nigra on transcranial ultrasound, possible subthreshold parkinsonism (as assessed by UPDRS-III), REM sleep behavioral disorder (RBD), olfactory impairment, constipation, excessive daytime sleepiness, orthostatic hypotension, urinary dysfunction, severe erectile dysfunction, depression / anxiety, activity of the dopamine transporter, RBD confirmed by polysomnography, genetic tests, type II diabetes mellitus, physical activity, serum urate levels, cognitive functions assessed with the Mini Mental State Examination \[Berg et al, 2015; Heinzel et al, 2019\]. Healthy subjects with risk or prodromal factors for PD should have a probability of developing PD \<50% according to the criteria of the MDS \[Berg et al, 2015; Heinzel et al, 2019\].
In addition to the selected patients, a study will also be conducted on patient data in the reference database of the proposing institution.
\- Exclusion: Patients who do not consent to study participation
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT05150158
Study Brief:
Protocol Section:
NCT05150158