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 · Has a placebo group

Conditions studied: Parkinson Disease, Parkinson, Idiopathic Parkinson Disease, Early Parkinson Disease (Early PD), Parkinson Disease, Idiopathic

In brief

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.

Key facts

Study ID

NCT06680830

Run by

Neuron23 Inc.

People needed

150

Starts

2025-01-17

Expected to finish

2028-06-01

Last updated by the study team

2026-07-30

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• University of Arkansas — Little Rock, Arkansas, United States (enrolling)
• Neuro-Pain Medical Center — Fresno, California, United States (enrolling)
• University of California, Irvine — Irvine, California, United States (enrolling)
• University of California, Los Angeles — Los Angeles, California, United States (enrolling)
• Esperanza Clinical — Murrieta, California, United States (enrolling)
• Parkinson's Research Centers of America - Palo Alto — Palo Alto, California, United States (enrolling)
• Sutter Neuroscience Institute — Sacramento, California, United States (enrolling)
• University of Colorado - Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Neurology One — Orlando, Florida, United States (enrolling)
• USF Parkinson's & Movement Disorders Clinic — Tampa, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Augusta University — Augusta, Georgia, United States (enrolling)
• Northwestern Medical Group, Department of Neurology — Chicago, Illinois, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• University of Maryland — Baltimore, Maryland, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• Quest Research Institute — Farmington Hills, Michigan, United States (enrolling)
• Struthers Parkinson Center — Golden Valley, Minnesota, United States (enrolling)
• Cleveland Clinic — Las Vegas, Nevada, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• Banner Sun Health Research Institute — Sun City, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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