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 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT05885360
Eligibility Criteria:
Inclusion Criteria:
* · Written informed consent
* Capable of providing informed consent and complying with study procedures
* Clinical diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria which includes the following.
* Bradykinesia
* At least one of the following:
* Muscular righty
* 4-6 Hz rest tremor
* Postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction
* Must be on a stable regimen of all current concomitant medication, including carbidopa-levodopa for at least 30 days prior to baseline visit
* Participants also have a MOCA (Montreal Cognitive Assessment) score of 22 or greater
* Study subjects are willing to present for all study visits and take medication.
* The MDS-UPDRS I-III will be used to assess a baseline tremor score
Exclusion Criteria:
* · Diagnosis of dementia - defined by NIH as the loss of cognitive functioning such as thinking, remembering, and reasoning, to such an extent that it interferes with a person's daily life and activities.
* Parkinson's plus syndromes or any other disorder other than idiopathic Parkinson's disease
* Moderate to severe dyskinesia is defined as:
* Moderate: Dyskinesias impact on activity to the point that the patient usually does not perform some activities or does not usually participate in some social activities during dyskinetic episodes
* Severe: Dyskinesia impacts activities to the point that the patient usually does not perform most activities or participate in most social activities during dyskinetic episodes
* Patients with severe cardiac disease or congestive heart failure
* Severe uncontrolled orthostatic hypotension
* Psychosis or psychotic symptoms that would raise concern for safe use of IST, as indicated by domains A (delusions) and B (hallucinations) of the Neuropsychiatric Inventory (NPI), and defined as a score of ≥ 4 on either the A (frequency x severity) or B (frequency x severity) scales of the NPI
* Active neoplastic disorder
* Current treatment with strong CYP3A4 inhibitors
* Current treatment with strong CYP3A4 inducers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05885360
Study Brief:
Protocol Section:
NCT05885360