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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT04518059
Eligibility Criteria:
Inclusion Criteria:
* Age 21 years old and age \<90 years of age at the time of the baseline visit 1
* Age of diagnosis at least 40 years old for PD, DLB, and PSP and at least 30 years old for MSA
* A confirmed diagnosis of PD, PSP, CBD, MSA, DLB, or healthy control
* Montreal Cognitive Assessment (MoCA) \> 10 at the outset of the study
Exclusion Criteria:
* Age 90 or above
* Allergy to local anesthetic
* History of deep brain stimulation (DBS) or other brain surgery prior to Visit 1
* For PD or DLB diagnoses, any other neurodegenerative or central nervous system process that would interfere with examination
* For PD or DLB, history of negative DATscan
* Use of investigational drugs or devices within 60 days prior to baseline visit (except for dietary supplements)
* In control subjects, family history of a neurodegenerative disease in a first degree or second degree blood relative
* History of schizophrenia
* History of antipsychotic medication use or exposure in controls or history of antipsychotic medication leading to parkinsonism (drug induced parkinsonism) in the parkinsonism group
* Blood clotting disorder
* On multiple (more than one) antiplatelet and/or anticoagulant blood thinner medications in combination (except for aspirin if it can be safely held for 1 week)
* Any other medical, psychiatric, or cognitive illness that in the investigator's opinion would interfere with cooperation or ability to undergo the study procedures.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
89 Years
Study:
NCT04518059
Study Brief:
Protocol Section:
NCT04518059