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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT03611569
Eligibility Criteria:
Inclusion criteria:
Healthy subjects:
\- Men and women ≥18 and ≤55 years of age with a body mass index (BMI) ≥18 and ≤32 kg/m2 (non-Japanese subjects) and ≥18 and ≤28 kg/m2 (Japanese subjects)
Patients with Parkinson's disease:
* Men and women with a clinical diagnosis of idiopathic Parkinson's disease, Hoehn and Yahn (H\&Y, stage 1-3)
* For a minimum of three months prior to enrolment, Parkinson's disease symptoms have been stable and is anticipated to be stable during the study duration as judged by the PI
* If on Parkinson's disease treatment the dose must be stable for a minimum of three months prior to enrolment and is anticipated to be stable during the study duration as judged by the PI
* ≥40 and ≤80 years of age
* BMI ≥18 and ≤35 kg/m2
Exclusion criteria:
* Atypical Parkinsonism
* Clinically relevant structural brain abnormality, as assessed using MRI
* Mild cognitive impairment, measured as a Montreal cognitive assessment (MoCA) score =\<21
* Any past or current treatment with an active vaccine targeting alpha-synuclein
* Any past or current treatment with a monoclonal antibody within the last 12 months
Other in- and exclusion criteria may apply.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03611569
Study Brief:
Protocol Section:
NCT03611569