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

NCT06680830 · tracked via the Priya Life Science UK tracker

Sponsor

Neuron23 Inc.

Phase

Phase 2

Started

2025-01-17

Last updated

2026-08-28

Condition(s) studied

Parkinson DiseaseParkinsonIdiopathic Parkinson DiseaseEarly Parkinson Disease (Early PD)Parkinson Disease, Idiopathic

Investigational drug(s) / intervention(s)

NEU-411Placebo

NEU-411: NEU-411, a potent, selective, orally bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity

Placebo: Orally-administered matched placebo

Study summary

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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo — From enrollment to the end of treatment at 52 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo — From enrollment to the end of study at 54 weeks

Trial sites (72)

Facility	City	Region	Status
Banner Sun Health Research Institute	Sun City	Arizona	Recruiting
University of Arkansas	Little Rock	Arkansas	Recruiting
Neuro-Pain Medical Center	Fresno	California	Recruiting
University of California, Irvine	Irvine	California	Recruiting
University of California, Los Angeles	Los Angeles	California	Recruiting
Esperanza Clinical	Murrieta	California	Recruiting
Parkinson's Research Centers of America - Palo Alto	Palo Alto	California	Recruiting
Sutter Neuroscience Institute	Sacramento	California	Recruiting
University of Colorado - Anschutz Medical Campus	Aurora	Colorado	Recruiting
Parkinson's Disease and Movement Disorders Center of Boca Raton	Boca Raton	Florida	Recruiting
University of Florida	Gainesville	Florida	Recruiting
Neurology One	Orlando	Florida	Recruiting
USF Parkinson's & Movement Disorders Clinic	Tampa	Florida	Recruiting
Emory University	Atlanta	Georgia	Recruiting
Augusta University	Augusta	Georgia	Recruiting
Northwestern Medical Group, Department of Neurology	Chicago	Illinois	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
University of Kentucky	Lexington	Kentucky	Recruiting
Ochsner Clinic Foundation	New Orleans	Louisiana	Recruiting
University of Maryland	Baltimore	Maryland	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
Quest Research Institute	Farmington Hills	Michigan	Recruiting
Struthers Parkinson Center	Golden Valley	Minnesota	Recruiting
Cleveland Clinic	Las Vegas	Nevada	Recruiting
University of New Mexico	Albuquerque	New Mexico	Recruiting
Northwell Health	Manhasset	New York	Recruiting
Icahn School of Medicine at Mount Sinai/Mount Sinai West	New York	New York	Recruiting
Columbia University	New York	New York	Recruiting
University of Rochester	Rochester	New York	Recruiting
University of North Carolina - Chapel Hill	Chapel Hill	North Carolina	Recruiting
The Ohio State University	Columbus	Ohio	Recruiting
The Movement Disorder Clinic of Oklahoma	Tulsa	Oklahoma	Recruiting
Oregon Health & Science University (OHSU)	Portland	Oregon	Recruiting
Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Vanderbilt University	Nashville	Tennessee	Recruiting
Neurology Consultants of Dallas PA	Dallas	Texas	Recruiting
Baylor College of Medicine	Houston	Texas	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	Recruiting
Central Texas Neurology Consultants	Round Rock	Texas	Recruiting

+ 32 more sites — see the full list on the official registry below.

Other trials for the same condition

Abbott DBS Post-Market Study of Outcomes for Indications Over Time Recruiting

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation Active, not recruiting

A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD) Recruiting

An Observational Study of Patients With Moderate Parkinson's Disease Enrolling by invitation

Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06680830 on ClinicalTrials.gov ↗ ← All trials in the UK