Actively Recruiting
Phase 2 Study of NEU-411 in Adults Aged 40-80 With Early Parkinsons Disease and LRRK2 Genetic Marker Includes Randomized, Placebo-Controlled Treatment and Open-Label Extension
Led by Neuron23 Inc. · Updated on 2026-07-30
150
Participants Needed
70
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating NEU-411 in adults aged 40 to 80 years who have early Parkinsons Disease PD with elevated activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 study aims to assess the safety and effectiveness of NEU-411, a selective brain-penetrant inhibitor of LRRK2, compared to placebo in participants with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411 at 30 mg once daily or a matching placebo for a 52-week treatment period. After this phase, participants may join an open-label extension to receive NEU-411 treatment for an additional 26 weeks. The study evaluates treatment effects on PD symptoms and adverse events. During the study, participants will undergo assessments including the Roche digital biomarker score using a Parkinsons Disease application and the Movement Disorder Societys Unified Parkinsons Disease Rating Scale. Safety monitoring includes tracking treatment-emergent and serious adverse events, with a follow-up visit scheduled within two weeks after treatment ends. Total study participation may extend up to 78 weeks including the extension phase.
CONDITIONS
Brief Title
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Research Team
F
Fatta B Nahab, MD, FAAN, FANA
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