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NCT Number: NCT04724941

Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease 4, Autosomal Dominant Lewy Body Parkinsonian Disorders Synucleinopathies

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department for Neurology, University of Kiel

Kiel, 24118, Germany

Location status: Recruiting

Location contact

Eva Schäffer, Dr.

CONTACT

[email protected]

004943150023983

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Risk marker profile

    Time frame: Analysis after three years.

    Extend and progression of risk marker profile

Secondary outcomes

  1. Non-motor and motor symptoms

    Time frame: Analysis after three years

    Development and progression of non-motor and motor symptoms

Study contacts

Contact information is provided by the study sponsor or research team.

Eva Schaeffer, Dr.

CONTACT

[email protected]

004943150023983

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • UCB Biopharma SRL
  • University of Kiel

Registry information

Acronym: PASS-PD

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2021
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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