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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT06209502
Eligibility Criteria:
Inclusion Criteria:
* Males and females between the ages of 30 and 75
* Agree to download and install the Koios Care application to their personal Android smartphone.
* People diagnosed with idiopathic PD based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present, without any other known or suspected cause of Parkinson's Disease.
o PD patients that are under the effects of a Deep Brain Stimulation (DBS) device or a levodopa pump (duodopa or lecigimon). Given that all other conditions are also met.
* Score between one-and-a-half (1.5) and three (3) at the H\&Y rating scale in the "ON" state (population A)
* Score of one (1) at the H\&Y rating scale in the "ON" state (population B)
Exclusion Criteria:
* The candidate cannot speak or comprehend the French/Dutch (depending on the clinical site s/he belongs to) language at a sufficient level.
* The reluctance of the candidate or her/his inability to provide written consent (e.g., due to mental health problems or severe physical disabilities).
* The candidate is not an Android smartphone owner and user for at least six (6) months.
* The candidate's Android smartphone is not compatible with the Koios Care application.
* The candidate suffers from dementia as judged by the investigator. For this we will use MMSE score with a cut-off value ≥ 24.
* The candidate has exhibited uncontrolled/extreme measures of depression as judged by the expert investigator, e.g., self-harm, suicide attempts or patient admitted to the hospital for a similar reason.
\-- If the participant develops such behavior or s/he is admitted to the hospital for the above reasons during the study, then the candidate is immediately removed from the study.
* Any Parkinson's disease-related feature or symptom that could interfere with the study conduct and results as assessed by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT06209502
Study Brief:
Protocol Section:
NCT06209502