Clinical Trial

A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

Study acronym: NEULARK
Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-09 -> 2027-12 2026-06-10
minor Completion pushed: 2027-09 -> 2028-06 2026-06-10
Trial Details
NCT Number NCT06680830
Lead Sponsor Neuron23 Inc.
Collaborators: Qiagen Manchester Limited, Roche Diagnostic Ltd.
Conditions Parkinson Disease, Parkinson, Idiopathic Parkinson Disease, Early Parkinson Disease (Early PD), Parkinson Disease, Idiopathic
Enrollment 150 participants
Start Date 2025-01-17
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-30