Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia

This is a randomized, placebo-controlled, double-blind study investigating whether the medication Ambroxol is safe,effectiveness and well tolerated for the treatment of Lewy Body Dementia (LBD). Currently the main treatments for patients with LBD target symptom management. However, none of the medications treat the underlying cause of the disease, which includes the accumulation of protein in the brain. Therefore, even if patients respond well to symptomatic treatment, they continue to deteriorate. Therefore, the purpose of the current study is to make sure Ambroxol is safe to take long term and to test the effects of Ambroxol in treating the cognitive impairments associated with LBD by modifying the underlying causes of the disease. There will be a total of 15 people participating this this study, which will last 52 weeks. Over the study period patients will undergo clinical, neuropsychological and neuroimaging assessment to assess changes.

NCT Number	NCT04405596
Lead Sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions	Lewy Body Disease
Enrollment	15 participants
Start Date	2025-01
Primary Completion	2026-01 (estimated)
Study Completion	2027-01 (estimated)
Updated on ClinicalTrials.gov	2023-12-13