A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Recruiting now Phase 2 NCT06680830
Run by Neuron23 Inc. · for 40 to 80 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- Aged 40-80 years at time of screening, inclusive
- Diagnosis of clinically established or clinically probable Parkinson's Disease (PD)
- LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx)
- Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5
🚫 You may not be able to join if…
- Secondary or atypical parkinsonian syndromes
- Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
- 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
- Banner Sun Health Research Institute, Sun City, Arizona, United States
- University of Arkansas, Little Rock, Arkansas, United States
- Neuro-Pain Medical Center, Fresno, California, United States
- University of California, Irvine, Irvine, California, United States
- University of California, Los Angeles, Los Angeles, California, United States
- Esperanza Clinical, Murrieta, California, United States
- Parkinson's Research Centers of America - Palo Alto, Palo Alto, California, United States
- Sutter Neuroscience Institute, Sacramento, California, United States
- University of Colorado - Anschutz Medical Campus, Aurora, Colorado, United States
- Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, United States
- University of Florida, Gainesville, Florida, United States
- Neurology One, Orlando, Florida, United States
+ 58 more sites.
Who to contact
Fatta B Nahab, MD, FAAN, FANA · 650-228-2527 · clinicaltrials@neuron23.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06680830.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.