Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study (PASS-PD)

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Eva Schaeffer, Dr.; Phone Number: 004943150023983; Email: eva.schaeffer@uksh.de

Study Locations

• Germany
  • Kiel, Germany, 24118
    • Recruiting
    • Department for Neurology, University of Kiel
    • Contact: Eva Schäffer, Dr.; Phone Number: 004943150023983; Email: eva.schaeffer@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

General population

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
REM behavior disorder +; 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; No intervention
REM behavior disorder -; 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; No intervention

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: University of Kiel; UCB Biopharma SRL
• Investigators: Principal Investigator: Daniela Berg, Prof.Dr., Department for Neurology, University of Kiel

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Prodromal; Alpha-Synuclein; Risk disclosure
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Parkinson Disease 4, Autosomal Dominant Lewy Body
• Other Study ID Numbers: PASS_PD_D440/2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After successful analysis and publication of data the clinical data can be shared upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No