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Enrolling by invitationOBSERVATIONAL

An Observational Study of Patients With Moderate Parkinson's Disease

This study is for people living with moderate Parkinson's disease. Researchers want to observe how your symptoms and general well-being change over several months when you take part. You'll continue with your usual Parkinson's medicines, though the study doctor might suggest tweaks to help manage your symptoms better. The study doesn't involve new medicines; it's about carefully watching the condition's progress. You’ll have regular check-ups where doctors and nurses will assess your symptoms. This helps them understand the daily challenges and changes people with Parkinson’s experience. The study lasts between 3 and 24 months, providing valuable insights into the condition.

At a glance

Status
Enrolling by invitation
Sponsor
Novo Nordisk A/S
Enrolment target
96
Start
05 Apr 2023
Estimated completion
11 Mar 2030

What is this study about?

This study is designed to carefully observe a group of people who have moderate Parkinson’s disease. It’s what we call an 'observational study,' which means no new treatments are being tested. Instead, the main goal is to follow participants over time to see how their symptoms and overall health change, and how these changes might be affected by being part of a study like this.

Participants in this study will continue to take their regular Parkinson's medicines as prescribed by their own doctor. However, the study doctors keep a close eye on your condition and might suggest some adjustments to your current medication if they think it could help manage your Parkinson's symptoms more effectively. This is done in the same way your regular doctor might adjust your medication, aiming to improve your well-being.

By carefully tracking your symptoms and experiences, doctors hope to gain a better understanding of how Parkinson's disease progresses and how different aspects of daily life and medication management affect people living with the condition. This information can be really helpful for developing better support and treatment approaches in the future for lots of other people with Parkinson's.

Key takeaways

  • This is an 'observational' study, not testing new drugs.
  • Your Parkinson's symptoms and health will be closely monitored.
  • Your usual medication will continue, with potential expert adjustments.
  • Participation lasts between 3 months and 2 years.
  • It helps doctors learn more about Parkinson's over time.

Who may be eligible?

To join this study, you need to be a man or woman between 50 and 68 years old. You must have been formally diagnosed with Parkinson's disease, specifically a moderate form that has been present for more than 5 years but no longer than 12 years.

Your Parkinson's symptoms should not be fully controlled by your current medicines, meaning you experience both 'on' periods (when medicine works well) and 'off' periods (when symptoms return more strongly). Importantly, doctors should also believe you might be suitable for a special cell therapy treatment in the future, and expect you to live for more than 7 more years.

There are also reasons why you might not be able to join. For example, if your Parkinson's is thought to be caused by something else, or if you have severe uncontrollable movements (dyskinesia) from your medication. The study also cannot include people with severe memory problems, serious mental health conditions like severe depression or psychosis, or other major illnesses that might make it unsafe to participate.

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.

  1. Are you between 50 and 68 years old?
  2. Do you have a confirmed diagnosis of moderate Parkinson's disease?
  3. Has your Parkinson's been diagnosed for 5 to 12 years?
  4. Do you experience 'on' and 'off' periods despite your current medication?
  5. Do you have good overall health, without severe memory problems or serious mental health conditions?
Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will last anywhere from 3 months up to 2 years. During this time, you will have regular visits to a clinic. At these visits, a study doctor or nurse will check your Parkinson's symptoms using various assessments. You’ll continue to take your usual Parkinson's medications, but the study doctor might suggest some changes to them if they think it would help your symptoms.

At a minimum of two of your clinic visits, you will be asked to undergo what are called 'off-assessments'. This means your symptoms will be evaluated when your medication is not fully active, which helps doctors understand the full range of your Parkinson's. Throughout the study, the team will monitor your health and how your Parkinson's symptoms are changing.

Potential risks and benefits

The main benefit of taking part in this study is contributing to a better understanding of Parkinson's disease, which could help others in the future. You will also have your condition closely monitored by specialists, and they might suggest adjustments to your current medication to improve your symptoms. Since no new treatments are given, the risks are generally low, but there's always a small chance that medication adjustments might have side effects, which the study team will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Joe C.Wen & Fam CTR for Adv Care
    Verified postcode
    Irvine, United States
  • NYU Langone Health
    Verified postcode
    New York, United States
  • NY Presbyt Hosp-W Cornell Med
    Verified postcode
    New York, United States
  • Keio University Hospital
    Verified postcode
    Shinjuku-ku, Tokyo, Japan
  • Neurologimottagningen Lund
    Verified postcode
    Lund, Sweden
  • Region Skane Skanes Universitetssjukhus
    Verified postcode
    Lund, Sweden
  • Clinical Neuroscience
    Verified postcode
    Cambridge, United Kingdom
  • University of Cambridge - Clinical Neuroscience
    Verified postcode
    Cambridge, United Kingdom

Common questions

What kind of study is this?

It's an 'observational study,' meaning researchers will watch and record information about your Parkinson's symptoms and health over time. No new treatments are given.

Will my regular medication change?

You'll keep taking your usual Parkinson's medicines. The study doctor might suggest adjustments, just like your own doctor might, to help manage your symptoms better.

How long does the study last?

Your involvement could be for as short as 3 months or as long as 2 years (24 months).

What are 'off-assessments'?

These are check-ups where your symptoms are evaluated when your medication isn't fully working, to understand your Parkinson's more completely.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "An Observational Study of Patients With Moderate Parkinson's…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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