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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT05806866
Eligibility Criteria:
Between March 30th, 2014 and December 31th, 2017, a large cohort of 268 people with Parkinson's disease were recruited within the frame of the" Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease" (ABC-PD) study. First follow-up was conducted between July 2018 and September 2020, including 182 (67.9%) patients. Those people with Parkinson's disease will be invited to participate in the proposed second follow-up assessment. If people with Parkinson's disease are not able to attend a clinical visit in-house, possibility of assessments at patients' homes shall be offered.
If people with Parkinson's disease or legal guardians give their consent a caregiver with regular contact to the patients will be ask to give information about patients instrumental activities of daily living, motor and non-motor status.
Inclusion Criteria:
* Participant in the " Amyloid-Beta in cerebrospinal fluid as a risk factor for cognitive dysfunction in Parkinson's Disease" (ABC-PD) study
* Diagnosis of Parkinson's disease according to the United Kingdom Brain Bank criteria.
* Ability to communicate well with the investigator, to understand and comply with the requirements of the study.
* Provide written informed consent to participate in the study and understand the right to withdraw consent at any time without prejudice to future medical care.
* If people with Parkinson's disease are not able to give consent for study participation (confirmed by an independent physician), study consent of a legal guardian is required.
Exclusion Criteria:
* Any disability that may prevent the subject from completing the informed consent form or other study requirements.
* Other neurodegenerative disease which renders the subject unable to communicate well with the investigator or to understand and comply with the requirements of the study.
* Participation in any clinical investigation of a new investigational compound or therapy within 4 weeks prior to baseline visit, and any other limitation of participation based on local regulations.
* Alcohol, medication, or drug dependency or abuse (except for nicotine).
* History of brain disease other than Parkinson's disease, e.g., head trauma, stroke, encephalitis.
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
95 Years
Study:
NCT05806866
Study Brief:
Protocol Section:
NCT05806866