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)

Trial ID: NCT06680830

Interventional - Phase 2 - Recruiting

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.

Conditions

• Parkinson Disease
• Parkinson
• Idiopathic Parkinson Disease
• Early Parkinson Disease (Early PD)
• Parkinson Disease, Idiopathic

Interventions

• NEU-411
• Placebo

Eligibility

Inclusion criteria

• 1. Aged 40-80 years at time of screening, inclusive
• 2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
• 3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
• 4. Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5

Exclusion criteria

• 1. Secondary or atypical parkinsonian syndromes
• 2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8%
• 3. Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)
• Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.

Sponsor

Neuron23 Inc., Qiagen Manchester Limited, Roche Diagnostic Ltd.

Source: ClinicalTrials.gov

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