Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

Study Overview
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Brief Summary
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The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.

Detailed Description
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The PASS-PP Study is designed to combine the latest developments in clinical and biomarker research to understand the distribution of risk profiles for PD in the general population, especially regarding non-motor symptoms identify subjects with a likelihood of developing PD follow individuals with a high likelihood/risk to develop PD in the future (compared to individuals with low risk and) in a prospective study understand the potential of biological markers to increase prediction of progression/conversion identify subtypes of PD patients, by providing a detailed clinical phenotyping with a main focus on non-motor symptoms cluster provide a framework of ethical handling of early risk disclosure in PD

Official Title
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Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 50 and 99 Exclusion Criteria: Presence of clinical PD at the time of study inclusion Other significant neurologic diseases affecting the central nervous system (e.g. Multiple sclerosis) other significant diseases e.g. orthopaedic diseases affecting quantitative motor assessment in case of participation in the lumbal puncture substudy: contraindications for the performance of lumbal puncture (bleeding tendency, intake of anticoagulants)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| REM behavior disorder +<br>Individuals with REM Sleep Behavior Disorder: All individuals will be included in a prospective, longitudinal observational study, including an annual investigation at the Department for Neurology (detailed anamnesis, neurological examination, motor assessment). Blood sampling will be performed every six months, non-motor symptoms will be assessed every three months using online surveys. All individuals can participate in an optional substudy including lumbar punctures every two years. | Other: No intervention<br>* No intervention<br>|
| REM behavior disorder -<br>Individuals without REM Sleep Behavior Disorder with increased risk for PD: All individuals will be included in a prospective, longitudinal observational study, including an annual investigation at the Department for Neurology (detailed anamnesis, neurological examination, motor assessment). Blood sampling will be performed every six months, non-motor symptoms will be assessed every three months using online surveys. All individuals can participate in an optional substudy including lumbar punctures every two years. | Other: No intervention<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk marker profile | Extend and progression of risk marker profile | Analysis after three years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-motor and motor symptoms | Development and progression of non-motor and motor symptoms | Analysis after three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alpha-Synuclein, Risk disclosure, Prodromal