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:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-25 @ 4:43 AM
NCT ID:
NCT04075318
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged 40 to 85 years old, inclusive at screening
* Expected to be able to undergo all study procedures
* Other inclusion criteria apply
For Part B only:
* A diagnosis of PD, confirmed by a neurologist
* Hoehn \&Yahr Stage ≤ III at Screening
* Stable treatment of permitted antiparkinsonian medications from 30 days prior to first study drug administration or 60 days for MAO-B inhibitors, and expected to remain stable throughout the study
Exclusion Criteria:
* Clinically significant abnormalities, as judged by the investigator
* History of medical, neurological or psychiatric conditions which in the opinion of the investigator may compromise participant's safety or scientific value of the study
* Acute or chronic infection as judged by the investigator, for positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
* History or evidence of an autoimmune disorder
* History of anergy.
* Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn
* Other exclusion criteria apply
For Part B only:
* Other known or suspected cause of Parkinsonism other than idiopathic PD
* History or evidence at Screening of PD-related freezing episodes, falls, or orthostatic hypotension
* Dopamine transporter single-photon emission computerized tomography scan (DaTscan) inconsistent with dopamine transporter deficit.
* Clinically significant neurological disease other than PD
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT04075318
Study Brief:
Protocol Section:
NCT04075318