Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

Parkinson Disease Clinical Trial

— PASS-PD  

Official title:

Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724941
• Other study ID #: PASS_PD_D440/2
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: May 2024
• Source: University Hospital Schleswig-Holstein
• Contact: Eva Schaeffer, Dr.
• Phone: 004943150023983
• Email: eva.schaeffer[@]uksh.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	Department for Neurology, University of Kiel	Kiel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	UCB Biopharma SRL, University of Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk marker profile	Extend and progression of risk marker profile	Analysis after three years.
Secondary	Non-motor and motor symptoms	Development and progression of non-motor and motor symptoms	Analysis after three years