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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT07139756
Eligibility Criteria:
Phase 1:
Inclusion Criteria:
* Signed informed consent
* Age ≥ 18 years and \<75 years
* Normal office blood pressure (\<140/90 mmHg)
* For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
Exclusion Criteria:
* Schellong test showing OH (drop of Systolic BP \>20 mmHg or Diastolic BP \>10 mmHg)
* Pregnant or lactating women
* Refusal to be informed of incidental findings
* Any medication (acute or chronic prescription) except oral contraception
* Clinical significant abnormal blood test as assessed by the investigator
* Chronic or acute illness
* Concomitant participation in a clinical trial
* Blood donation in the 60 previous days
* Contra-indications for MRI
* Unable to follow study procedures
* Having a hierarchical relationship with the investigator or being family of the investigator
Phase 2:
Inclusion Criteria:
* Signed informed consent
* Fulfilling Movement Disorder Society clinical criteria for "clinically established PD"
* Age ≥18 years and \<75 years
* PD treated by dopamine replacement therapy (DRT)
* Willing and able to comply with the visit schedule and study procedures
* Autonomous in daily life
* Schellong test showing OH (drop of Systolic BP \>20 mmHg or Diastolic BP \>10 mmHg)(for study group with OH) or no OH (for studygroup without OH)
* For women of childbearing potential: using or willing to use during the study a reliable contraception method compatible with MRI
Exclusion Criteria:
* Unable to give an informed consent
* BP \> 180/110 mmHg on 24-hour ambulatory blood pressure monitoring
* eGFR \< 45 ml/min/1.73 ml/min/m2 by CKD-EPI equation
* having contra-indications for MRI
* Pregnant or lactating women
* Refusal to be informed of incidental findings
* Allergy to components of contrast agent Sonovue®
* Living in an institution
* Dementia
* Type 2 diabetes
* Stroke or myocardial infarction in the past 6 months
* Blood donation in the previous 6 months
* Active oncology treatment
* Having a hierarchical relationship with the investigator or being family of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07139756
Study Brief:
Protocol Section:
NCT07139756