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

May 6, 2024 updated by: Eva Schaeffer, University Hospital Schleswig-Holstein
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Kiel, Germany, 24118
        • Recruiting
        • Department for Neurology, University of Kiel
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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
Time Frame: Analysis after three years.
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
Time Frame: Analysis after three years
Development and progression of non-motor and motor symptoms
Analysis after three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 2026

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 (Actual)

May 7, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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