The placebo-controlled Phase III study will examine if Ambroxol, a long-established cough medication might halt the advancement of Parkinson’s disease and enhance the quality of life for patients.
Currently, the medication Ambroxol is used to treat respiratory diseases. It has anti-inflammatory effects, facilitates coughing, and encourages mucus clearing.
How Ambroxol May Work For People With Parkinson’s Disease?
Ambroxol has been found as a potential treatment to halt the course of Parkinson’s disease in pre-clinical research directed by Professor Schapira at the UCL Queen Square Institute of Neurology.
In January 2020, the findings of Professor Schapira’s Phase 2 clinical trial at UCL testing ambroxol in Parkinson’s patients were released. It was discovered that ambroxol may effectively enter the brain and raise concentrations of the GCase protein (glucocerebrosidase).
GCase allows cells to remove waste proteins, including alpha-synuclein (a protein that builds up in Parkinson’s and is thought to be important in its cause), more effectively. Furthermore, the Phase 2 trial demonstrated that Ambroxol was well tolerated and safe for Parkinson’s patients.
Professor Anthony Schapira is in charge of the groundbreaking Phase 3 trial, known as ASPro-PD, which is conducted in cooperation with the UK. After working with the Parkinson’s community for eight years, the charity Cure Parkinson’s and Van Andel Institute were established.
330 Parkinson’s patients will participate in the experiment in 10–12 clinical facilities in the United Kingdom. Participants will take Ambroxol for two years, and the study will be placebo-controlled.
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Effectiveness
Ambroxol’s effectiveness will be evaluated by how well it slows the course of Parkinson’s using a scale that takes movement and quality of life into account. The process of acquiring study participants has already begun.
Prof. Schapira declared, “I am delighted to be in charge of this fascinating research. This marks the culmination of 10 years of in-depth and meticulous work in the laboratory and in a proof of concept clinical trial, and it will mark the first time a medicine directly addressed to a genetic etiology of Parkinson’s disease has reached this level of study.”
The design of the study is the result of significant input from Parkinson’s patients, experts in the field, trial design and statistics from the UCL Comprehensive Clinical Trials Unit (CCTU), the MHRA, and a group of funders led by Cure Parkinson’s, who have all worked together effectively to ensure we have reached this point.
Ambroxol, which is available as a pill and a syrup, is already used to reduce coughing in people with respiratory illnesses by removing mucus from their lungs. However, it also raises the amount of the GCase protein, generally known as glucocerebrosidase, in the brain.
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