Ambroxol for Lewy Body Dementia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether Ambroxol is safe and effective for treating Lewy Body Dementia (LBD), a brain disorder affecting thinking and movement. Current treatments only address symptoms, but Ambroxol aims to reduce protein buildup in the brain, targeting the root cause. Participants will receive either Ambroxol (Ambroxol Hydrochloride) or a placebo (a non-active look-alike) to assess its impact on memory and thinking over a year. The trial seeks individuals diagnosed with LBD who have been on stable medications for related symptoms for at least three months and have a caregiver available most days. As a Phase 1, Phase 2 trial, it focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that you stay on a stable dose of your current medications for parkinsonism, cognition, and psychiatric conditions for at least 3 months before starting. However, you cannot take certain blood thinners like Warfarin during the trial.
Is there any evidence suggesting that Ambroxol is likely to be safe for humans?
Research has shown that Ambroxol is generally safe for people with certain types of dementia. In earlier studies, it was tested on individuals with Parkinson’s Disease Dementia (PDD) and found to be safe, with no major safety issues reported.
Ambroxol is also under investigation for other types of dementia, such as Lewy Body Dementia (LBD). These studies explore whether it can slow the disease by addressing its root causes. While the main focus is on its effectiveness, the safety data collected so far indicates that many patients tolerate it well.
Ambroxol is also used for other health conditions, which supports its safety profile. However, it is always important to consider the specific details of any clinical trial and discuss any concerns with the study team.12345Why do researchers think this study treatment might be promising for Lewy Body Dementia?
Most treatments for Lewy Body Dementia focus on managing symptoms through drugs like cholinesterase inhibitors and antipsychotics. But Ambroxol offers a fresh approach by targeting the underlying cause of the disease. Ambroxol is unique because it is believed to increase the activity of the glucocerebrosidase enzyme, potentially slowing disease progression. This mechanism is different from standard treatments that primarily address symptoms rather than the disease itself. Researchers are excited about Ambroxol because it holds the promise of not just alleviating symptoms but also altering the disease's course.
What evidence suggests that Ambroxol might be an effective treatment for Lewy Body Dementia?
In this trial, participants will be randomized to receive either Ambroxol or a placebo. Research has shown that Ambroxol has potential for treating Lewy Body Dementia (LBD), a condition characterized by protein buildup in the brain. Studies have found Ambroxol to be safe and generally well-tolerated, though its effectiveness in alleviating dementia symptoms like memory and thinking problems remains uncertain. Some research on Parkinson's disease dementia, a condition similar to LBD, also found Ambroxol to be safe but did not provide strong evidence of symptom improvement. Ambroxol might address the underlying causes of the disease rather than just the symptoms, offering hope for future effectiveness. More research is needed to understand its impact on LBD specifically.23456
Are You a Good Fit for This Trial?
This trial is for people over 50 with Lewy Body Dementia, who have a caregiver at least 4 days a week and are on stable medication for parkinsonism, cognition, and psychiatric symptoms. Pregnant women or those planning to conceive during the study can't participate. People with metal in their body that affects MRI scans or taking certain blood thinners also can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ambroxol or placebo for 52 weeks to assess safety and effectiveness in treating Lewy Body Dementia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ambroxol Hydrochloride
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre OR Lawson Research Institute of St. Joseph's
Lead Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead Sponsor
Lawson Health Research Institute
Lead Sponsor