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 @ 4:42 PM
Ignite Modification Date:
2025-12-24 @ 4:42 PM
NCT ID:
NCT05589766
Eligibility Criteria:
Inclusion Criteria:
* Clinically established diagnosis of idiopathic PD according to the MDS criteria.
* 123I-Ioflupane dopamine transporter imaging (DAT-scan) confirming nigrostriatal degeneration.
* Hoehn and Yahr score \< 4 at enrolment.
* Age ≥ 40 years at the time of enrollment.
* Able to undergo lumbar punction.
* Able to undergo MRI.
Exclusion Criteria:
* Dementia or other neurodegenerative disorder at baseline visit.
* Diagnosed with atypical parkinsonism (progressive supranuclear palsy (PSP), multiple system atrophy (MSA), corticobasal degeneration (CBD)) or vascular parkinsonism.
* Any psychiatric disorder that would interfere with compliance in the study.
* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
* Use of high dose vitamin B3 supplementation within 30 days of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
100 Years
Study:
NCT05589766
Study Brief:
Protocol Section:
NCT05589766