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:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT06941012
Eligibility Criteria:
Inclusion Criteria:
* • For PD subjects
* PD diagnosis according to MDS-UPDRS criteria and Hoehn and Yahr scale between I-IV (MED ON) for PD subjects
* Willing to participate. Participation is always voluntary.
* Willing and able to provide written informed consent to participate in the study or having a legal representative responsible for signing; the participant (or the legal representative) must understand the purpose, methods, and all information regarding the study.
* For non-PD subjects
* Normal neurological examination findings.
* Medical record (recent and remote medical history) available and reviewable by clinicians during the entire study period.
* Willing and able to provide written informed consent to participate in the study
Exclusion Criteria:
* • For PD and non-PD subjects
* Clinically significant and severe cognitive decline and/or intellectual disability which can lead to impairment not caused by Parkinson's disease or any other disease that could better explain the patient's symptoms; The exclusion criteria involve neurological and neurodevelopmental disorders including disorders of the brain, spinal cord, peripheral nerve, and muscle (e.g. cerebral palsy, epilepsy \[seizure disorders\], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury).
* Fever (Temperature 38.0 °C (tympanic)).
* Acute infection (such as Flu, COVID-19) which could debilitate the patient and affect the data.
* Individuals with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the pre-dose examinations (e.g. HepC, HIV, TB).
* Life-threatening co-existing disease with life expectancy, which could lead to premature dropout.
* Any other neurological or systemic conditions that could confound results.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06941012
Study Brief:
Protocol Section:
NCT06941012