Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

Recruiting

• Conditions: Parkinson Disease
• Interventions: Other: No intervention

• Registration Number: NCT04724941
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

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

The PASS-PP Study is designed to combine the latest developments in clinical and biomarker research to

1. understand the distribution of risk profiles for PD in the general population, especially regarding non-motor symptoms

2. identify subjects with a likelihood of developing PD

3. follow individuals with a high likelihood/risk to develop PD in the future (compared to individuals with low risk and) in a prospective study

4. understand the potential of biological markers to increase prediction of progression/conversion

5. identify subtypes of PD patients, by providing a detailed clinical phenotyping with a main focus on non-motor symptoms cluster

6. provide a framework of ethical handling of early risk disclosure in PD

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-26
• Study Start: 2021-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Primary Completion: 2025-03
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
REM behavior disorder -	No intervention	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.
REM behavior disorder +	No intervention	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.

Primary Outcome Measures

Name	Time	Method
Risk marker profile	Analysis after three years.	Extend and progression of risk marker profile

Secondary Outcome Measures

Name	Time	Method
Non-motor and motor symptoms	Analysis after three years	Development and progression of non-motor and motor symptoms

Trial Locations

Locations (1)

Department for Neurology, University of Kiel; 🇩🇪 Kiel, Germany