Recruiting
Phase 2

NEU-411

Sponsor:

Neuron23 Inc.

Code:

NCT06680830

Conditions

Parkinson Disease

Parkinson

Idiopathic Parkinson Disease

Early Parkinson Disease (Early PD)

Parkinson Disease, Idiopathic

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

NEU-411

Placebo

Study Details

Brief 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.

Conditions

Parkinson Disease

Parkinson

Idiopathic Parkinson Disease

Early Parkinson Disease (Early PD)

Parkinson Disease, Idiopathic

Study ID

NCT06680830

Start date

Jan 17, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NEU-411

Orally-administered NEU-411

placebo comparator: Placebo

Orally-administered matching placebo

Interventions

NEU-411

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

Placebo

Orally-administered matched placebo

Primary outcome measure

  • Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo [ Time Frame: 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 [ Time Frame: From enrollment to the end of study at 54 weeks ]

Central Contacts and Locations

Central contacts

Fatta B Nahab, MD, FAAN, FANA

650-228-2527clinicaltrials@neuron23.com

Locations

Banner Sun Health Research Institute

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Principal Investigator:

David Shprecher, DO

University of Arkansas

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Rohit Dhall, MD

Neuro-Pain Medical Center

Recruiting

Fresno, California, United States, 93710

Contacts

Principal Investigator:

Perminder Bhatia, MD

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Principal Investigator:

Sanaz Attaripour Isfahani, MD

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Jeff Bronstein, MD, PhD

Esperanza Clinical

Recruiting

Murrieta, California, United States, 92562

Contacts

Principal Investigator:

Michael Ropacki, PhD

Parkinson's Research Centers of America - Palo Alto

Recruiting

Palo Alto, California, United States, 94301

Contacts

Principal Investigator:

Salima Brillman, MD

Sutter Neuroscience Institute

Recruiting

Sacramento, California, United States, 95816

Contacts

Principal Investigator:

Nicklesh Thakur, DO

University of Colorado - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Emily Forbes, DO

Parkinson's Disease and Movement Disorders Center of Boca Raton

Recruiting

Boca Raton, Florida, United States, 33486

Contacts

Principal Investigator:

Stuart Isaacson, MD, FAAN

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Principal Investigator:

Irene Malaty, MD

Neurology One

Recruiting

Orlando, Florida, United States, 32825

Contacts

Principal Investigator:

Ramon L Rodriguez, MD, FAAN

USF Parkinson's & Movement Disorders Clinic

Recruiting

Tampa, Florida, United States, 33613

Contacts

Principal Investigator:

Robert Hauser, MD, MBA, FAAN

Emory University

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Principal Investigator:

Stewart Factor, DO

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Principal Investigator:

John Morgan, MD, PhD

Northwestern Medical Group, Department of Neurology

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Danielle N Larson, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Principal Investigator:

Rajesh Pahwa, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Principal Investigator:

John Slevin, MD, MBA

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Principal Investigator:

David Houghton, MD

University of Maryland

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Principal Investigator:

Joseph Savitt, MD, PhD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Principal Investigator:

Ludy Shih, MD, MMSc

Quest Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Principal Investigator:

Aaron Ellenbogen, DO, MPH

Struthers Parkinson Center

Recruiting

Golden Valley, Minnesota, United States, 55427

Contacts

Principal Investigator:

Sotirios Parashos, MD, PhD

Cleveland Clinic

Recruiting

Las Vegas, Nevada, United States, 89106

Contacts

Principal Investigator:

Zoltan Mari, MD

University of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Principal Investigator:

Sarah P Richardson, MD, FAAN

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Principal Investigator:

Ritesh Ramdhani, MD

Icahn School of Medicine at Mount Sinai/Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Principal Investigator:

Joohi Jimenez-Shahed, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Columbia Movement Disorders Research

347-882-4315mdresearch@cumc.columbia.edu

Principal Investigator:

Sheng-Han Kuo, MD

University of Rochester

Recruiting

Rochester, New York, United States, 14618

Contacts

Principal Investigator:

Christopher Tarolli, MD

University of North Carolina - Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Daniel Roque, MD

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Ariane Park, MD, MPH

The Movement Disorder Clinic of Oklahoma

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Principal Investigator:

Kevin Klos, MD

Oregon Health & Science University (OHSU)

Recruiting

Portland, Oregon, United States, 97239

Contacts

Principal Investigator:

Joseph Quinn, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

Tsao-Wei Liang, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Christine Cooper, MD

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Principal Investigator:

David Charles, MD

Neurology Consultants of Dallas PA

Recruiting

Dallas, Texas, United States, 75243

Contacts

Principal Investigator:

Nirav Pavasia, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Arjun Tarakad, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Raja Mehanna, MD

Central Texas Neurology Consultants

Recruiting

Round Rock, Texas, United States, 78681

Contacts

Principal Investigator:

Elizabeth Peckham, DO

University of Utah Movement Division

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Principal Investigator:

Paolo Moretti, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Binit Shah, MD, FAAN

EvergreenHealth

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Principal Investigator:

Pinky Agarwal, MD, FAAN

Inland Northwest Research

Recruiting

Spokane, Washington, United States, 99202

Contacts

Principal Investigator:

Jason Aldred, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Karen Blindauer, MD

More Information

Sponsor

Neuron23 Inc.

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Keywords

  • Early PD
  • Parkinsons
  • Parkinsons Disease
  • Idiopathic Parkinsons Disease
  • leucine-rich repeat kinase 2
  • PD
  • NEULARK
  • LRRK2
  • PARK8
  • de novo Parkinsons disease
  • Parkinson's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Neuron23 Inc. on 2026-08-28.