Not yet recruitingPHASE1, PHASE2INTERVENTIONAL

Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia

This study is looking at a new medicine called Ambroxol for people with Lewy Body Dementia (LBD). Currently, treatments for LBD only help with symptoms, but don't stop the disease from getting worse. This research aims to see if Ambroxol can safely treat the underlying problem in LBD, which is the build-up of certain proteins in the brain. By targeting this cause, the hope is to improve thinking abilities and slow down the disease's progression. The study will involve 15 people over 52 weeks, carefully checking their health, memory, and brain changes. This is an early-stage study to understand if Ambroxol could be a helpful long-term treatment for LBD.

At a glance

Status

Not yet recruiting

Phase

PHASE1, PHASE2

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Enrolment target

Start

01 Jan 2025

Estimated completion

01 Jan 2027

Lewy Body Disease

What is this study about?

Lewy Body Dementia (LBD) is a serious brain condition that affects many people in the UK. It's a type of dementia where tiny clumps of a protein, called alpha-synuclein, build up inside brain cells. These clumps, known as Lewy bodies, can damage brain cells and lead to problems with thinking, memory, movement, and sleep. While there are some treatments available now, they mostly help manage the symptoms rather than tackling the root cause of the disease itself. This means that even with treatment, the condition can unfortunately continue to worsen over time.

This study, called 'Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia', is exploring whether a medicine called Ambroxol could be a new way to treat LBD. Instead of just treating the symptoms, Ambroxol is being investigated to see if it can modify the disease process itself. This means it might be able to help stop or slow down the build-up of those harmful proteins in the brain, potentially improving thinking abilities and the overall course of the disease.

The main goal of this research is to find out if taking Ambroxol is safe for people with LBD over a longer period. We also want to understand if it can help with the thinking and memory problems that are common in LBD by addressing the underlying cause. This kind of research is very important because finding treatments that can slow or stop the progression of LBD could make a big difference to patients and their families.

Key takeaways

This study investigates Ambroxol for Lewy Body Dementia.
It aims to treat the disease's underlying cause, not just symptoms.
The study lasts 52 weeks and involves health, memory, and brain scans.
It's a crucial step in finding new, effective LBD treatments.
Participation contributes to vital research for a common condition.

Who may be eligible?

To join this study, doctors will first check if you meet certain requirements. You must have a likely diagnosis of Lewy Body Dementia and be aged 50 or older. Your general thinking and memory will be assessed using a common test, and your score needs to fall within a specific range.

It's very important that you have a caregiver who can spend at least four days a week helping you. If you're currently taking medicines for Parkinson's-like symptoms, thinking problems, or mood, you'll need to have been on a steady dose for at least three months before starting the study.

There are also reasons why you might not be able to join. These include having had a stroke or another serious brain condition, or any other major health issue like cancer or an unstable heart condition that could affect the study's results. You also can't take part if you have certain metal implants that would make an MRI scan unsafe, or if you're unable to have a special brain scan called a DAT-scan. If you're pregnant, breastfeeding, or planning to get pregnant, you won't be able to join. Lastly, if you are taking certain blood-thinning medications, you may not be able to participate. Your study doctor will discuss all these points with you in detail.

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.

Do I have a diagnosis of Lewy Body Dementia?
Am I aged 50 or older?
Do I have a caregiver who can help me at least 4 days a week?
Have my current medications for Parkinson's, thinking, or mood been stable for at least 3 months?
Do I have any serious heart conditions, stroke, or other major health issues?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for a total of 52 weeks, which is about one year. During this time, you'll be given either the study medicine, Ambroxol, or a placebo. A placebo looks just like the real medicine but contains no active ingredients. This is done so we can accurately compare the effects of the actual medicine.

Throughout the year, you will have regular visits to the clinic. At these visits, the study team will carry out various checks and tests. These will include looking at your general health, assessing your thinking and memory abilities (neuropsychological assessments), and having brain scans (neuroimaging). These assessments help us to see if there are any changes in your condition or in how your brain is working. The study team will explain exactly what each visit involves and how long it will take.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from closer medical attention and access to a new treatment that isn't yet widely available, and your participation will contribute to valuable medical knowledge that could help future patients. However, there's no guarantee that Ambroxol will help your condition, and you might experience side effects from the medication. You also might receive the placebo. All potential risks will be fully explained to you before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Parkwood Institute
Verified postcode
London, Canada

Common questions

What is Lewy Body Dementia?

It's a common type of dementia caused by tiny protein clumps in the brain, affecting thinking, movement, and memory.

What is Ambroxol?

It's a medicine being tested to see if it can target the cause of Lewy Body Dementia, rather than just treating symptoms.

How long will the study last?

The study will last for about 52 weeks, which is one year.

Will I definitely get the active medicine?

No, this is a 'placebo-controlled' study, meaning some participants will receive the active medicine and others a dummy pill.

What does a 'caregiver' mean in this study?

It means you need someone who can help and support you for at least four days a week during the study.

How to find out more

Stephen Pasternak, MD, PhD

spasternak@robarts.ca 519-646-6000 Official trial record

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