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Investigating NEU-411 for Early Parkinson's Disease

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)

PHASE2 · Neuron23 Inc. · NCT06680830

This study is testing a new drug called NEU-411 to see if it can help people aged 50-80 with early Parkinson's Disease who have a specific genetic marker.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment150 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorNeuron23 Inc. (industry)
Locations70 sites (Sun City, Arizona and 69 other locations)
Trial IDNCT06680830 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial aims to evaluate the efficacy and safety of NEU-411 in individuals aged 50-80 with early Parkinson's Disease who have elevated activity in the LRRK2 pathway, identified through a genetic test. Participants will be randomly assigned to receive either NEU-411 or a placebo daily for 52 weeks. The study will assess various outcomes, including the drug's pharmacokinetics and pharmacodynamics, compared to placebo. A follow-up visit will occur two weeks after the treatment period to monitor safety.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 50-80 with clinically established or probable Parkinson's Disease and LRRK2-driven PD.

Not a fit: Patients with secondary or atypical parkinsonian syndromes or uncontrolled diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a targeted therapeutic option for patients with early Parkinson's Disease driven by LRRK2 activity.

How similar studies have performed: Other studies targeting the LRRK2 pathway have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Sun City, Arizona and 69 other locations

+20 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Parkinson Disease, Parkinson, Idiopathic Parkinson Disease, Early Parkinson Disease, Parkinson Disease, Idiopathic, Early PD, Parkinsons, Parkinsons Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.