RecruitingOBSERVATIONAL

HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development for Huntington's Disease

The HDClarity study is looking for at least 2,500 people with Huntington's disease (HD) at different stages. The main goal is to collect high-quality samples of spinal fluid (obtained through a lumbar puncture) and blood. These samples will help scientists discover important clues about how HD progresses and what might stop it. By carefully examining these fluids, researchers hope to find 'biomarkers' – natural signals in the body that can show how the disease is developing or how well a treatment is working. This knowledge is vital for developing new and more effective treatments for HD, ultimately aiming to improve the lives of those affected by this condition. Your participation could make a real difference in future treatments.

At a glance

Status

Recruiting

Sponsor

University College, London

Enrolment target

2,500

Start

01 Jan 2017

Huntington's Disease

What is this study about?

HDClarity is a big research project focused on understanding Huntington's disease (HD) much better. The main idea is to collect and study samples of spinal fluid and blood from a large number of people with HD. Think of spinal fluid as the liquid cushion around your brain and spine – it can hold important clues about what's happening inside your nervous system. By looking closely at these samples, researchers hope to find specific 'marks' or 'signals' (called biomarkers) that can tell them more about how HD works and how it affects the body.

Why is this so important? Well, finding these biomarkers can help scientists in a few key ways. Firstly, they might be able to spot HD earlier or track its progress more accurately. Secondly, and perhaps most excitingly, these biomarkers could point towards new targets for medicines. If researchers can understand the exact changes happening in the body due to HD, they can design treatments that specifically address those changes, leading to more effective new drugs.

This study isn't testing a new drug itself; instead, it's about collecting vital information that will help others develop those drugs in the future. By joining, you'll be contributing to a global effort to unravel the mysteries of HD and bring hope for better treatments to thousands of people.

Key takeaways

This study helps scientists find new ways to treat Huntington's disease.
It involves collecting blood and spinal fluid samples (lumbar puncture).
You would attend about two visits per year.
It's an 'observational' study, not testing a new drug.
Participation is voluntary, and you can withdraw at any time.
Your contribution is vital for future HD treatments for others.

Who may be eligible?

To take part in the HDClarity study, you generally need to be between 18 and 75 years old, though younger people (from 11 years) with a specific type of HD might be included. If you're a healthy control, you'll also fit within the 18-75 age range. You must be able to understand what the study involves and agree to take part, or have a parent or guardian who can consent for you if you're under 18. Also, if you have HD, you must have had a genetic test to confirm your diagnosis.

There are also some reasons why you might not be able to join. For example, if you've recently taken part in another drug trial (within the last month) or if your medications for HD have changed recently. If you have certain medical conditions like problems with blood clotting, severe headaches, or have had recent back surgery, or have a strong fear of needles, you might not be suitable. It's also important that you don't have problems with drug or alcohol misuse, and for women who could become pregnant, a positive pregnancy test would mean you couldn't take part. The study also needs to be sure you'll be able to stick to the planned appointments.

Quick self-check

Are you generally aged between 18 and 75? (Some younger people with HD are included).
Do you have a confirmed genetic test for Huntington's disease (if you have HD)?
Are you able to agree to take part, or do you have a parent/guardian who can?
Have you avoided other drug trials or medication changes for your HD in the last month?
Do you feel comfortable with blood tests and a lumbar puncture?
Are you able to attend appointments as scheduled?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join the HDClarity study, it's an 'observational' study, meaning researchers will monitor things over time rather than giving you new medicines. You'd typically have two main visits each year. The first is a 'screening' visit where the study team will ask about your health history and do some checks. If everything looks okay and you're still happy to continue, you'd then come back for a 'sampling' visit. At this visit, you'd need to fast (not eat or drink, except water) for at least 6 hours, or overnight. Then, blood samples would be taken from your arm, and a sample of spinal fluid would be collected through a procedure called a lumbar puncture (a needle inserted into your lower back). Some people might also be asked to come for an extra sampling visit about 1-2 months after their first one, but this is optional. These annual visits will continue for several years, but you are not obliged to attend every single visit and can skip one without being removed from the study. If you miss three sampling visits in a row, you'd be taken out of the study, but you could rejoin later if you change your mind.

Potential risks and benefits

While you won't directly benefit from new treatments during this observational study, your participation is incredibly valuable. The information gathered from your samples will be crucial for helping scientists understand Huntington's disease better and develop future treatments that could help many others. When taking part, there are some potential risks. The blood tests involve a needle, which can cause slight pain or bruising. The lumbar puncture, while generally safe, can sometimes lead to a headache afterwards, or a small amount of pain or bruising in your back. The study team will explain these procedures in detail and ensure your safety and comfort are their priority. Remember, joining is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, which would not affect your medical care.

Locations (40)

Cenexel
Englewood, United States· Recruiting
Georgetown University
Washington D.C., United States· Recruiting
John Hopkins University
Baltimore, United States· Recruiting
Wake Forest University
Winston-Salem, United States· Completed
Vanderbilt University Medical Center
Nashville, United States· Recruiting
University of Texas Health Science Center
Houston, United States· Recruiting
University of British Columbia, The Centre for Huntingtons Disease
Vancouver, Canada· Active not recruiting
The Ottawa Hospital
Ottawa, Canada· Recruiting
North York General Hospital
Toronto, Canada· Recruiting
Centre for Movement Disorders
Toronto, Canada· Completed
Centre Hospitalier Universitaire d'Angers
Angers, France· Recruiting
Le Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France· Recruiting

+28 more sites — see the official record for the full list.

Common questions

What is a lumbar puncture?

A lumbar puncture is a procedure where a very thin needle is carefully inserted into your lower back to collect a small sample of the fluid that surrounds your brain and spinal cord, called spinal fluid. It's done by trained medical staff.

Will I be given any new medication in this study?

No, this study is 'observational,' meaning you won't be given any new treatments or medications. Researchers are simply collecting information and samples to understand Huntington's disease better for future drug development.

How often do I need to attend appointments?

Typically, you would have two main study visits each year – a screening visit and then a sampling visit. Some people might also be asked for an optional extra sampling visit in their first year.

Can I leave the study at any time?

Yes, absolutely. Your participation is completely voluntary, and you are free to withdraw from the study at any point, for any reason, without it affecting your medical care.

What happens to my samples?

Your blood and spinal fluid samples will be carefully stored and used by researchers to look for 'biomarkers' and study pathways related to Huntington's disease. This information helps them understand the disease and develop new treatments.

How to find out more

Katarzyna Schubert, PhD

hdclarity-cc@enroll-hd.org Official trial record

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