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NEU-411 maleate is an investigational substance being developed for the treatment of Parkinson's disease. It has not received marketing authorisation and is currently being evaluated in a Phase 2 clinical trial. The substance is being studied specifically in people whose Parkinson's disease is driven by mutations in the LRRK2 gene, identified through a companion diagnostic test.[1]
The trial is designed to evaluate NEU-411 in participants with LRRK2-driven Parkinson's disease. LRRK2 is a gene that, when mutated, is one of the most common genetic causes of Parkinson's disease. The trial targets this specific genetic subgroup of Parkinson's disease, suggesting that NEU-411 is intended to act on pathways related to the LRRK2 mutation, although the registry record does not describe the exact molecular mechanism.[1]
In the Phase 2 trial, NEU-411 is given as a 30 mg oral dose. Participants take the substance by mouth, while those in the comparison arm receive a matching placebo.[1]
One clinical trial of NEU-411 maleate is registered in the databases provided. The trial, NCT06680830, is a Phase 2 interventional study that plans to enrol 150 participants with early, LRRK2-driven Parkinson's disease.[1]
The trial is currently authorised, meaning it has received regulatory approval to proceed but is not yet recruiting according to the registry record. Participants are randomly assigned to receive either 30 mg of NEU-411 by mouth or a placebo.[1]
The study measures two main outcomes. The first is the change from baseline in the Roche digital biomarker score, assessed using the Roche Parkinson's Disease application (v3.0), compared to placebo from enrolment to the end of treatment at 52 weeks. The second is the incidence of treatment-emergent adverse events and serious adverse events compared to placebo, measured from enrolment to the end of study at 54 weeks.[1]
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