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The Ambroxol Trial - The facts | The Cure Parkinson's Trust

Ambroxol as a novel disease-modifying treatment for Parkinson’s disease dementia: protocol for a single-centre, randomized, double-blind, placebo-controlled trial | BMC Neurology | Full Text

Cognitive decline and its implications to the life of individuals with PDD represent a significant burden to patients, caregivers, and the health care system. Current pharmacological therapies are helpful for cognitive symptoms in PDD but are unable to modify the course of disease progression, making treatment for cognition in PDD a major unmet need. Increasing levels of the GCase enzyme has been proposed as a potential therapy for slowing neurodegeneration in Parkinson’s disease, and consequently PDD. There is increasing evidence in cell culture and animal models of PD that Ambroxol can raise levels of GCase. Strikingly, increased levels of GCase were accompanied by decreased levels of α-synuclein aggregation in brain areas of mice treated with Ambroxol. The present trial is the first to test Ambroxol in human subjects with PDD. The effects of Ambroxol will be measured using standardized cognitive, functional, behavioural, biochemical, as well as brain imaging outcomes. Results from this clinical trial may have a large impact in the research of disease-modifying therapies for PDD and other synucleinopathies including Parkinson’s disease and Lewy Body dementia. Importantly, Ambroxol is a drug already commercially available in most of the world and has an excellent safety record. Thus, repurposing Ambroxol for the treatment of PDD may expedite a potential disease-modifying treatment and circumvent a lengthy drug development process.