AuthorisedTherapeutic exploratory (Phase II)Interventional

MEDICAL CANNABIS FOR NEURODEGENERATIVE DISEASES: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE II CLINICAL TRIAL (NEUROBIS)

This study, called NEUROBIS, is testing a cannabis-based medicine called Avextra 10/10 for people living with neurodegenerative diseases like Alzheimer's, Parkinson's, and Amyotrophic Lateral Sclerosis (ALS). Researchers want to find out if this medicine can improve their overall quality of life. They will compare it to a dummy treatment (placebo) to see if it makes a real difference. The study will also carefully check if the medicine is safe to use and how well people tolerate it, looking for any side effects. This is a Phase II study, meaning it's an early stage where scientists are still exploring if the treatment works and is safe before larger trials. Participants will not know if they are getting the active medicine or the dummy treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Enrolment target

186

Start

17 Jul 2024

Patients suffering from neurodegenerative diseases: Amyotrophic Lateral Sclerosis (ALS)Alzheimer’s Disease (AD) and Parkinson’s Disease (PD).

What is this study about?

This study, called NEUROBIS, is looking into how a specific cannabis-based medicine, named Avextra 10/10, might help people with certain brain conditions that get worse over time. These conditions are Alzheimer's disease, Parkinson's disease, and Amyotrophic Lateral Sclerosis (ALS).

The main goal of the study is to see if taking Avextra 10/10 can improve the overall quality of life for people with these conditions. Quality of life is about how well someone feels in general, including their physical health, mental health, and social life. To understand this, researchers will use a special questionnaire called the SF-36. They will compare the results from people taking the cannabis medicine with those taking a 'dummy' treatment (a placebo) that doesn't contain any active medicine.

Another very important part of this study is to check the safety of Avextra 10/10. The researchers will carefully watch for any side effects people might have while taking the medicine and see how well their bodies handle it. They are also interested in whether the medicine might help family members or carers feel less stressed, and how patients themselves feel about any changes. For people with specific conditions, like Alzheimer's, ALS, or Parkinson's, the study will also look at how it affects specific symptoms related to their disease.

Key takeaways

This study is exploring a cannabis-based medicine for Alzheimer's, Parkinson's, and ALS.
The main goal is to see if it improves overall quality of life.
Researchers will also carefully check for safety and side effects.
Participants may receive the active medicine or a dummy treatment (placebo).
It's an early-stage (Phase II) study, exploring potential benefits and safety.
There will be regular check-ups and assessments during the study.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older, and there's no upper age limit. The study is open to both men and women.

Specifically, you must have been diagnosed with one of these neurodegenerative diseases: Alzheimer's disease, Parkinson's disease, or Amyotrophic Lateral Sclerosis (ALS).

There will be other detailed health requirements that your hospital doctor or the study team will discuss with you. These are to make sure the study is right for you and that the results will be clear and reliable.

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 diagnosed with Alzheimer's disease, Parkinson's disease, or ALS?
Are you able to attend regular study appointments?
Are you willing to potentially receive either the active medicine or a dummy treatment?
Are you generally able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given either the active cannabis medicine (Avextra 10/10) or a dummy treatment (placebo). You won't know which one you're getting, and neither will your doctor, until the study is over. This is called 'double-blind'. Both the active medicine and the dummy treatment are given as a mixture of sesame and linseed oil.

Throughout the study, you'll have regular visits to the clinic so the research team can check on your health and how you're feeling. They will ask you questions about your quality of life using questionnaires like the SF-36. For carers, there will be interviews to understand their stress levels. If you have Alzheimer's, ALS, or Parkinson's, you'll have specific tests related to your condition.

The research team will also be closely monitoring you for any side effects and how well you are coping with the treatment. The total duration of your participation in the study, including visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial means there could be potential benefits, such as receiving a new medicine that might improve your quality of life. However, there's also a chance you might receive the dummy treatment, which has no active medicine. Like all medicines, the cannabis extract could have side effects, and these will be carefully monitored throughout the study. You will receive very close medical care and attention during your participation. You are free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What kind of medicine is Avextra 10/10?

It's a cannabis-based medicine being tested in this study.

What does 'double-blind' mean in this study?

It means neither you nor your doctor will know if you're getting the active medicine or a dummy treatment.

Which conditions are included in this study?

The study includes people with Alzheimer's disease, Parkinson's disease, or ALS.

What is the main thing the study hopes to achieve?

It aims to see if the medicine can improve the overall quality of life for participants.

Will I have to pay to take part in the study?

No, clinical trials usually cover the cost of study-related medication and assessments.