Phase 2RecruitingAge-related condition
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)
- Sponsor
- Neuron23 Inc. (Industry)
- Enrolment
- 150 planned
- Conditions
- Parkinson Disease; Parkinson; Idiopathic Parkinson Disease; Early Parkinson Disease (Early PD); Parkinson Disease, Idiopathic
- Interventions
- NEU-411; Placebo
- Ages
- adults, older adults
- Registry
- NCT06680830
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered