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 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT03568968
Eligibility Criteria:
Inclusion Criteria:
* Have a clinical diagnosis of idiopathic PD according to the MDS clinical diagnostic criteria for Parkinson's disease
* \[¹²³I\]FP-CIT single photon emission CT (DaTscan) confirming nigrostriatal degeneration
* Diagnosed with PD within 2 years from enrolment
* Hoehn and Yahr score \< 3 at enrolment
* Optimal symptomatic therapy, not requiring adjustments, for at least 1 month.
* Age equal to or greater than 35 years at time of enrolment.
Exclusion Criteria:
* Dementia or other neurodegenerative disorder at baseline visit
* Diagnosed with atypical parkinsonism or vascular parkinsonism
* Any psychiatric disorder that would interfere with compliance in the study.
* Any severe somatic illness that would make the individual unable to comply and participate in the study.
* Use of high dose vitamin B3 supplementation within 30 days of enrolment
* Metabolic, neoplastic, or other physically or mentally debilitating disorder at baseline visit.
* Genetically confirmed mitochondrial disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT03568968
Study Brief:
Protocol Section:
NCT03568968