Parkinson DiseasePASS-PDNCT04724941
Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
An observational study of Parkinson Disease, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2021to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population
Who may be able to join
- Age between 50 and 99
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department for Neurology, University of Kiel
Kiel, 24118
Eva Schäffer, Dr., 004943150023983, eva.schaeffer@uksh.de
About this 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.
Read the detailed description
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
- Conditions
- Parkinson Disease
- Being tested
- No intervention
- Keywords
- Prodromal, Alpha-Synuclein, Risk disclosure
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk marker profile
Extend and progression of risk marker profile
Measured: Analysis after three years.
Secondary outcomes (1)
Non-motor and motor symptoms
Development and progression of non-motor and motor symptoms
Measured: Analysis after three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jun 2021
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- UCB Biopharma SRL, University of Kiel
- Responsible party
- Principal investigator, Eva Schaeffer, University Hospital Schleswig-Holstein
- Investigators
- Daniela Berg, Prof.Dr., Principal investigator, Department for Neurology, University of Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724941
- Sponsor's protocol ID
- PASS_PD_D440/2
- Acronym
- PASS-PD
- Status last verified
- Sep 2025
- First submitted
- 21 Jan 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After successful analysis and publication of data the clinical data can be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
- ClinicalTrials.gov ID
- NCT04724941
- Acronym / sponsor ID
- PASS-PD / PASS_PD_D440/2
- Conditions
- Parkinson Disease
- Keywords
- Prodromal, Alpha-Synuclein, Risk disclosure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- UCB Biopharma SRL, University of Kiel
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REM behavior disorder + | – | Other: No interventionIndividuals 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. |
| REM behavior disorder - | – | Other: No interventionIndividuals 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. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (1 listed)
- Age between 50 and 99
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | REM behavior disorder +, REM behavior disorder - |
Primary outcome
Risk marker profile
Time frame: Analysis after three years.
Extend and progression of risk marker profile
1 secondary outcome
Non-motor and motor symptoms
Time frame: Analysis after three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided. After successful analysis and publication of data the clinical data can be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela Berg, Prof.Dr. principal investigator
Department for Neurology, University of Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Schaeffer, Dr. (004943150023983, eva.schaeffer@uksh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk marker profile (time frame: Analysis after three years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.