RecruitingNAINTERVENTIONAL

French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis

This study is investigating why people with Amyotrophic Lateral Sclerosis (ALS), also known as Motor Neuron Disease, often lose weight. Weight loss can be a significant challenge for people with ALS, and understanding its causes could lead to better ways to manage the condition. Researchers will gather information from ALS patients in France and Germany. They will collect blood samples to look for biological clues and ask participants to complete questionnaires about their health. By identifying what causes weight loss, the study aims to improve the care and quality of life for people living with ALS. This research does not involve new medicines, but rather helps us understand the disease better.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Limoges

Enrolment target

1,000

Start

17 Sep 2024

Estimated completion

30 Sep 2029

Amyotrophic Lateral Sclerosis

What is this study about?

This study is focused on Amyotrophic Lateral Sclerosis (ALS), which is also known as Motor Neuron Disease. It's a condition that affects the nerves in the brain and spinal cord, leading to muscle weakness. A common problem for people with ALS is losing weight, and this can happen both when first diagnosed and as the disease progresses.

While we know weight loss is common, doctors don't fully understand why it happens in ALS. This study aims to find those answers. By understanding the underlying reasons for weight loss, researchers hope to develop better strategies to help people with ALS maintain their weight. This could potentially improve their overall health, how they feel day-to-day, and even how long they live.

To do this, a team of doctors and researchers from France and Germany are working together. They are creating a large group of people with ALS (a cohort) who will take part. They will carefully study these individuals to find specific signals or 'markers' in their bodies that are linked to weight loss. This will involve collecting blood samples for detailed analysis and asking participants to fill out questionnaires about their health and lifestyle.

Key takeaways

This study explores why people with ALS lose weight.
It aims to find biological reasons for weight loss to improve patient care.
Participation involves questionnaires and blood samples, no new drugs.
The study includes patients from France and Germany.
Findings could help develop better ways to manage ALS and improve quality of life.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and have been recently diagnosed with ALS, according to specific medical guidelines. You must also be receiving your care at one of the specialist ALS centres taking part in France or Germany.

It's important that you are able to understand what the study involves and confirm you're happy to take part by signing a consent form. You should also be willing to take standard ALS medication, such as Riluzole, if prescribed by your doctor.

If you find it difficult to understand the study information, or if a medical condition prevents you from giving consent, you wouldn't be able to participate. This also applies if you are unwilling to take Riluzole therapy.

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 18 years old or older?
Have you been recently diagnosed with ALS?
Are you receiving your ALS care at a specialist centre in France or Germany that is part of the study?
Are you able to understand the study information and willing to sign a consent form?
Are you willing to take standard ALS medication like Riluzole if prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the usual high-quality care for ALS patients from your specialist centre. In addition, for this study, you will be asked to complete several questionnaires. These questionnaires will help the researchers understand more about your health and experiences. You will also have blood samples taken. These blood samples will be analysed to look for specific 'biological markers' that might be linked to weight loss. The study does not involve taking any new medications, only standard care, questionnaires, and blood tests. The total duration of participation will depend on the study's follow-up schedule, but researchers will explain this fully during the consent process.

Potential risks and benefits

Participating in this study might not directly benefit you, but it could help doctors understand weight loss in ALS better, leading to improved care for future patients. The main procedures involve blood collection, which carries a small risk of bruising or discomfort, and completing questionnaires. You are free to withdraw from the study at any time without giving a reason, and this will not affect the quality of your medical care.

Locations (7)

CHU de Lille
Verified postcode
Lille, France· Not yet recruiting
Limoges University Hospital
Verified postcode
Limoges, France· Recruiting
Hôpital de la Timone
Verified postcode
Marseille, France· Not yet recruiting
Hôpital Gui Chauliac
Verified postcode
Montpellier, France· Not yet recruiting
CHU de Nice
Verified postcode
Nice, France· Not yet recruiting
Hôpital de la Pitié Salpêtrière
Verified postcode
Paris, France· Not yet recruiting
CHU de Tours
Verified postcode
Tours, France· Not yet recruiting

Common questions

What is ALS?

ALS, or Amyotrophic Lateral Sclerosis, is a condition that affects nerve cells in the brain and spinal cord, leading to muscle weakness over time.

Why is weight loss important in ALS?

Weight loss is common in ALS and can affect how people feel and their overall health. Understanding it better could lead to improved treatments.

Will I receive new medicine in this study?

No, this study does not involve new medicines. You will continue to receive your usual, standard medical care for ALS.

How much blood will be taken?

Blood samples will be taken for analysis, similar to a routine blood test you might have at your doctor's surgery.

What happens to my information?

All information collected, including blood samples and questionnaire responses, will be handled with strict confidentiality and used only for research purposes.

How to find out more

Philippe COURATIER, Pr

philippe.couratier@chu-limoges.fr 05 55 05 15 69 Official trial record

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