RecruitingOBSERVATIONAL

Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

The PASS-PD study aims to find people in the general population who may be at a higher risk of developing Parkinson's disease. By following these individuals for five years, researchers hope to better understand the early signs, including non-motor symptoms like sleep problems or changes in smell, and how the condition progresses. The study also looks at how to talk ethically and responsibly about these early risks with individuals. It doesn't involve any new treatments or interventions; instead, it focuses on observation, collecting information, and using biological markers to improve our ability to predict Parkinson's and identify different types of the disease. The goal is to make future diagnoses and support better.

At a glance

Status

Recruiting

Sponsor

University Hospital Schleswig-Holstein

Enrolment target

2,000

Start

01 Jun 2021

Estimated completion

01 Dec 2027

Parkinson Disease

What is this study about?

The Parkinson's Disease (PD) study, called PASS-PD, is designed to help us understand more about who might get Parkinson's disease in the future and why. Researchers are interested in finding people who show signs that could mean they have a higher chance of developing the condition, even if they don't have it right now. They want to follow these people over five years to see how things develop.

This study is important because it will help doctors and researchers learn more about the very early stages of Parkinson's disease. This includes looking at things beyond the more obvious movement problems, such as changes in sleep, mood, or sense of smell. By understanding these 'non-motor' symptoms better, and combining this with information from biological tests, we might be able to predict Parkinson's disease earlier and understand different forms it can take.

Another key part of this study is making sure that any information about someone's future risk of Parkinson's is shared in a careful and ethical way. It's all about gathering knowledge to help us better understand, diagnose, and eventually manage Parkinson's disease in the future.

Key takeaways

A study searching for early signs of Parkinson's disease.
No new treatments are involved, it's about observation and learning.
Participants will be followed for five years.
Aims to understand risk factors and different types of Parkinson's.
Helps improve future diagnosis and support for others.
Results will be shared carefully and ethically.

Who may be eligible?

This study is looking for participants who are aged between 50 and 99 years old. It's open to everyone, regardless of gender.

You would not be able to take part if you have already been diagnosed with Parkinson's disease or if you have other serious brain or nerve conditions, like Multiple Sclerosis. Also, if you have other significant health problems, for example, certain bone or joint conditions that might make it hard to do movement tests, you wouldn't be eligible.

For a small group of participants who might be asked to have a special test called a lumbar puncture (spinal tap), certain medical conditions or medications that affect blood clotting would prevent you from taking part in that specific part of the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 50 and 99 years old?
Have you been diagnosed with Parkinson's disease already? (If yes, you can't join.)
Do you have other serious brain or nerve conditions? (If yes, you can't join.)
Do you have other major illnesses that might affect movement tests, like severe arthritis or bone problems? (If yes, you might not be able to join.)
For the optional spinal fluid test: Do you have issues with bleeding or take blood thinners? (If yes, you can't have this specific test.)

Answer every question to see your result.

What does participation involve?

If you take part in the study, you won't be receiving any new treatments or medicines. Instead, it's about observation and gathering information. Researchers will follow up with you over a period of five years. This will involve regular visits where they will carry out various assessments, such as looking at your signs and symptoms, and possibly collecting samples for biological tests. The exact number of visits and tests will be explained in detail if you are considered for the study. Your commitment would be to attend these appointments as scheduled over the five-year period.

Potential risks and benefits

There are no direct medical benefits to you from participating in this study, as it does not involve any new treatments. However, your involvement will greatly help researchers understand Parkinson's disease better, which could lead to improved diagnosis and support for others in the future. The risks of participating are generally low, mainly related to the time commitment for appointments and possible discomfort from any tests, such as blood tests or, for some, a lumbar puncture. You will be fully informed of all procedures and can decide to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Department for Neurology, University of Kiel
Verified postcode
Kiel, Germany· Recruiting

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain and can cause problems with movement, like shaking, stiffness, and difficulty with balance. It can also cause other symptoms, like sleep problems or changes in mood.

Will I get any medicine or treatment in this study?

No, this study is not about trying out new medicines or treatments. It's an observational study, which means researchers will be watching and collecting information to learn more about Parkinson's disease.

What does a 'biological marker' mean?

Biological markers are things found in your blood, spinal fluid, or other body parts that can give doctors clues about your health or a particular condition. In this study, they're looking for markers that might help predict Parkinson's disease.

How long will I be involved in the study?

If you take part, researchers will follow up with you for a period of five years, attending regular appointments during that time.

What does 'ethical handling of early risk disclosure' refer to?

This means that if the study finds you might be at a higher risk of developing Parkinson's in the future, the researchers will have a very careful and sensitive way of sharing this information with you, ensuring you have support and understand what it means.

How to find out more

Eva Schaeffer, Dr.

eva.schaeffer@uksh.de 004943150023983 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.