Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04724941

Acronym

PASS-PD

Enrollment

2000

Registered

2021-01-26

Start date

2021-06-01

Completion date

2027-12-31

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Prodromal, Alpha-Synuclein, Risk disclosure

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

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 99 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Risk marker profile	Analysis after three years.	Extend and progression of risk marker profile

Secondary

Measure	Time frame	Description
Non-motor and motor symptoms	Analysis after three years	Development and progression of non-motor and motor symptoms

Countries

Germany

Contacts

Primary ContactEva Schaeffer, Dr.

eva.schaeffer@uksh.de004943150023983

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026