Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Parkinson Disease. Basic parameters: 50 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Other No intervention
No intervention
Primary outcome measures
- Risk marker profile [Time frame: Analysis after three years.]
Secondary outcome measures (1)
- Non-motor and motor symptoms [Time frame: Analysis after three years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department for Neurology, University of Kiel — Kiel
Identifiers
NCT: NCT04724941 · PASS_PD_D440/2