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

RecruitingPhase 2Ages 40 Years - 80 YearsAllNeuron23 Inc.
NCT06680830 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • NEU-411
  • Placebo
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Where

72 sites
Banner Sun Health Research Institute
Sun City, United States
University of Arkansas
Little Rock, United States
Neuro-Pain Medical Center
Fresno, United States
University of California, Irvine
Irvine, United States
University of California, Los Angeles
Los Angeles, United States
Esperanza Clinical
Murrieta, United States
Parkinson's Research Centers of America - Palo Alto
Palo Alto, United States
Sutter Neuroscience Institute
Sacramento, United States

…and 64 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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