Recruiting · registry status

Testing a medicine for a genetically identified Parkinson’s group

This study tests NEU-411 in early Parkinson’s. A genetic test identifies people predicted to have increased activity in the biological pathway the medicine targets.

Testing a treatment or activity · Study reference: NCT06680830

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 40 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.

Full study name & original research details

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)

Short title used by the registry

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

Original description

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.

Further description from the registry

NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study and open-label extension (OLE) in participants with early Parkinson's Disease (PD) who have LRRK2-driven PD as measured by an investigational companion diagnostic genetic test (CDx). The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity as compared to placebo. After participants are screened for inclusion in the randomized, placebo-controlled portion of the study, approximately 150 participants will be randomized in a 1:1 allocation to NEU-411 30 mg once per day or placebo for a 52-week treatment period with a safety follow-up visit within 2 weeks after the last treatment visit. Eligible participants may enroll in the OLE and receive treatment for an additional 26 weeks.

Conditions reported: Parkinson Disease; Parkinson; Idiopathic Parkinson Disease; Early Parkinson Disease (Early PD); Parkinson Disease, Idiopathic

Study type: Interventional
Interventions: NEU-411; Placebo
Phases: PHASE2
Sponsor: Neuron23 Inc.
Start date reported by registry: 2025-01-17 (actual)

Registry updated: 2026-10-02 · Status last verified by the registry submitter: 2026-08

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Fatta B Nahab, MD, FAAN, FANA · 650-228-2527 · clinicaltrials@neuron23.com

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Banner Sun Health Research Institute

Sun City, Arizona, United States

Recruiting

Serena Lowery · 623-832-0080 · Serena.Lowery@Bannerhealth.com

David Shprecher, DO

University of Arkansas

Little Rock, Arkansas, United States

Recruiting

Erin Hatcher · 501-214-2178 · EHatcher@uams.edu

Rohit Dhall, MD

Neuro-Pain Medical Center

Fresno, California, United States

Recruiting

Mirian Payo · 559-437-9700 · mirianp@neuropain.com

Perminder Bhatia, MD

University of California, Irvine

Irvine, California, United States

Recruiting

Rene Anguiano · 949-824-6407 · renea1@hs.uci.edu

Sanaz Attaripour Isfahani, MD

University of California, Los Angeles

Los Angeles, California, United States

Recruiting

Diane Yang · 310-206-3356 · DDYang@mednet.ucla.edu

Jeff Bronstein, MD, PhD

Esperanza Clinical

Murrieta, California, United States

Completed

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States

Recruiting

Leeana Bade · 650-394-6690 · Lbade@Parkinsonscenter.org

Salima Brillman, MD

Sutter Neuroscience Institute

Sacramento, California, United States

Recruiting

Sampreet Moneski · 916-887-4736 · sampreet.moneski@sutterhealth.org

Nicklesh Thakur, DO

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Recruiting

Emily Forbes, DO · 303-724-4644 · Neuroresearch@cuanschutz.edu

Emily Forbes, DO

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Recruiting

Karla Arias · 561-392-1818 · karias@parkinsonscenter.org

Stuart Isaacson, MD, FAAN

University of Florida

Gainesville, Florida, United States

Recruiting

Camille Swartz · 352-733-2429 · cami.swartz@neurology.ufl.edu

Irene Malaty, MD

Neurology One

Orlando, Florida, United States

Recruiting

Carem Acosta · 407-674-1648 · cacosta@neurologyone.com

Ramon L Rodriguez, MD, FAAN

USF Parkinson's & Movement Disorders Clinic

Tampa, Florida, United States

Recruiting

Erica Botting · 813-974-8026 · ericabotting@usf.edu

Robert Hauser, MD, MBA, FAAN

Emory University

Atlanta, Georgia, United States

Recruiting

Brian Sperin · brian.a.sperin@emory.edu

Stewart Factor, DO

Augusta University

Augusta, Georgia, United States

Recruiting

Buff Farrow · 706-721-0619 · BFARROW@augusta.edu

John Morgan, MD, PhD

Northwestern Medical Group, Department of Neurology

Chicago, Illinois, United States

Recruiting

Camryn Butze · 312-503-6824 · camryn.butze@northwestern.edu

Danielle N Larson, MD

University of Kansas Medical Center

Kansas City, Kansas, United States

Recruiting

Emily Jackson · 913-588-0859 · ejackson9@kumc.edu

Rajesh Pahwa, MD

University of Kentucky

Lexington, Kentucky, United States

Recruiting

Corisa Logan · 859-218-5076 · corisa.logan@uky.edu

John Slevin, MD, MBA

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Recruiting

Anna Leonard-Leumas · 504-842-0148 · anna.leonardleumas@ochsner.org

David Houghton, MD

University of Maryland

Baltimore, Maryland, United States

Recruiting

Victoria Davis · 410-328-4526 · vdavis@som.umaryland.edu

Joseph Savitt, MD, PhD

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Recruiting

Alexandra Gottlieb · 617-667-9890 · agottli2@bidmc.harvard.edu

Ludy Shih, MD, MMSc

Quest Research Institute

Farmington Hills, Michigan, United States

Recruiting

Nancy Virdi · 248-957-8944 · Nancy.Virdi@alcanzaclinical.com

Aaron Ellenbogen, DO, MPH

Struthers Parkinson Center

Golden Valley, Minnesota, United States

Recruiting

Carrie Weaver · 952-993-5903 · carrie.a.weaver@healthpartners.com

Sotirios Parashos, MD, PhD

Cleveland Clinic

Las Vegas, Nevada, United States

Recruiting

Liliana Dumitrescu · 702-483-6000 · DUMITRL@ccf.org

Zoltan Mari, MD

University of New Mexico

Albuquerque, New Mexico, United States

Recruiting

Anna Tingin · 505-272-3342 · atingin@salud.unm.edu

Sarah P Richardson, MD, FAAN

Northwell Health

Manhasset, New York, United States

Recruiting

Nicholas Zumba · 516-472-5807 · Neuroscienceresearch@northwell.edu

Ritesh Ramdhani, MD

Icahn School of Medicine at Mount Sinai/Mount Sinai West

New York, New York, United States

Recruiting

Ricardo Renvill · 212-844-6055 · ricardo.revill@mountsinai.org

Joohi Jimenez-Shahed, MD

Columbia University

New York, New York, United States

Recruiting

Columbia Movement Disorders Research · 347-882-4315 · mdresearch@cumc.columbia.edu

Sheng-Han Kuo, MD

University of Rochester

Rochester, New York, United States

Recruiting

Amy Chesire · 585-341-7500 · Amy_Chesire@URMC.Rochester.edu

Christopher Tarolli, MD

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Recruiting

Jessica Ferrall · 919-962-8852 · jferrall@neurology.unc.edu

Daniel Roque, MD

The Ohio State University

Columbus, Ohio, United States

Recruiting

Katherine Ambrogi · 614-688-6685 · katherine.ambrogi@osumc.edu

Ariane Park, MD, MPH

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Recruiting

Elise Gibson · 918-392-4530 · mdcclinicaltrials@gmail.com

Kevin Klos, MD

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

Recruiting

Emily Leonard · 503-367-4719 · leonarde@ohsu.edu

Joseph Quinn, MD

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Recruiting

Brian Urbani · 215-955-2635 · Brian.Urbani@jefferson.edu

Tsao-Wei Liang, MD

Medical University of South Carolina

Charleston, South Carolina, United States

Recruiting

Robin Bulgarino · 843-792-1115 · Bulgarino@musc.edu

Christine Cooper, MD

Vanderbilt University

Nashville, Tennessee, United States

Recruiting

Haley Kling · 615-208-3974 · haley.kling@vumc.org

David Charles, MD

Neurology Consultants of Dallas PA

Dallas, Texas, United States

Recruiting

Maya Manjane · 214-750-9977 · maya.manjane@carumresearch.com

Nirav Pavasia, MD

Baylor College of Medicine

Houston, Texas, United States

Recruiting

Aneesch Martin · 713-798-2606 · aneesch.martin@bcm.edu

Arjun Tarakad, MD

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Recruiting

Brittany Duncan · 713-486-3134 · Brittany.J.Duncan@uth.tmc.edu

Raja Mehanna, MD

Central Texas Neurology Consultants

Round Rock, Texas, United States

Recruiting

Koni Lopez · 512-218-1222 · k.lopez@ctncpa.org

Elizabeth Peckham, DO

University of Utah Movement Division

Salt Lake City, Utah, United States

Recruiting

Kendra Fowler · 801-581-7828 · kendra.fowler@utah.edu

Paolo Moretti, MD

University of Virginia

Charlottesville, Virginia, United States

Recruiting

Lauren Miller · 434-982-6599 · FDK5DN@UVAHealth.org

Binit Shah, MD, FAAN

EvergreenHealth

Kirkland, Washington, United States

Recruiting

Ryuma Barnes · 425-899-5370 · robarnes@evergreenhealthcare.org

Pinky Agarwal, MD, FAAN

Inland Northwest Research

Spokane, Washington, United States

Recruiting

Michael Dauer · 509-960-2818 · mdauer@inwresearch.com

Jason Aldred, MD

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Recruiting

Shelby Schold · 414-955-0698 · sschold@mcw.edu

Karen Blindauer, MD

Rambam Medical Center

Haifa, Israel

Recruiting

Ilana Schlesinger, MD, Prof · 972-4-7771495 · i_schles@rmc.gov.il

Ilana Schlesinger, MD, Prof

Shaare Zedek Medical Center

Jerusalem, Israel

Recruiting

Yael Mimoun · 972-5-43184600 · yaelmi@szmc.org.il

Gilad Yahalom, MD, Prof

Sheba Medical Center

Ramat Gan, Israel

Recruiting

Adi Saar · 972-3-5304931 · adi.saar@sheba.health.gov.il

Sharon Hassin, MD, Prof

Tel Aviv Medical Center

Tel Aviv, Israel

Recruiting

Adi Ezra · 972-3-6974912 · adil@tlvmc.gov.il

Tanya Gurevich, MD, Prof

IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia

Milan, Italy

Recruiting

Daniela Capilupo · +39 0226434815 · capilupo.daniela@hsr.it

Massimo Filippi, MD, Prof

Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria

Naples, Italy

Recruiting

Teresa Del Santo · +39 3494026479 · delsantoteresa@gmail.com

Alessandro Tessitore, MD, PhD

Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica

Padua, Italy

Recruiting

Angelo Antonini · +39 0498213607 · angelo.antonini.pd@gmail.com

Angelo Antonini, MD, PhD, Prof

Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara

Pisa, Italy

Recruiting

Pierangela Riani · +39 050992567 · p.riani@ao-pisa.toscana.it

Roberta Ceravolo, MD, Prof

Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

Rome, Italy

Recruiting

Miriam Casali · +39 0652252311 · miriam.casali@sanraffaele.it

Fabrizio Stocchi, MD, PhD

Fondazione Policilinico Universitario A Gemelli IRCCS

Rome, Italy

Recruiting

Flavia Torlizzi · +39 0630155633 · flavia.torlizzi@policlinicogemelli.it

Anna Rita Bentivoglio, MD, PhD

Centrum Medyczne Neuromed

Bydgoszcz, Poland

Recruiting

Beata Lisewska · +48 696268565 · lisewskabeata@gmail.com

Pawel Lisewski, MD

NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski

Katowice, Poland

Recruiting

Katarzyna Smilowska · +48 600282870 · kasia.smilowska@gmail.com

Katarzyna Smilowska, MD, PhD

Pro Life Medica Sp. z o. o. ETA Lublin

Lublin, Poland

Recruiting

Dominika Tomaka, MD · +48 691485946 · d.tomaka@etg-network.org

Dominika Tomaka, MD

Insula Badania Sp. Z o.o.

Warsaw, Poland

Recruiting

Marta Jethon · +48 501035250 · jethon2@tlen.pl

Marta Jethon, MD

Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP)

San Sebastián, Donostia, Spain

Recruiting

Gurutz Linazasoro, MD · +34 943002812 · glinazasoro@vivebiotech.com

Gurutz Linazasoro, MD

Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces

Barakaldo, Spain

Recruiting

Naiara Azcue · +34 944881576 · azkue.naiara@gmail.com

Juan Carlos Gomez Esteban, MD, PhD

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Recruiting

Jorge Hernandez Vara, MD · +34 934893000 · jorge.hernandez@vallhebron.cat

Jorge Hernandez Vara, MD

Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.

Barcelona, Spain

Recruiting

Alicia Garrido, Pla · +34 932275785 · agarridop@clinic.cat

Alicia Garrido, Pla

Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

Madrid, Spain

Recruiting

Lydia Lopez Manzanares · +34 915202405 · lydia.lopez@salud.madrid.org

Lydia Lopez Manzanares, MD

Hospital Universitario HM Puerta del Sur

Móstoles, Spain

Recruiting

Patricia Vicente · +34 912673100 · pvicentefernandez@hmhospitales.com

Michele Matarazzo, MD

Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

Seville, Spain

Recruiting

Pablo Mir, MD · +34 955923039 · pmir@us.es

Pablo Mir, MD

St George's Hospital, University of London

London, England, United Kingdom

Recruiting

Francesca Morgante, MD · +44 20 8725 5403 · fmorgant@sgul.ac.uk

Francesca Morgante, MD

University College London Hospitals NHS Foundation Trust

London, England, United Kingdom

Recruiting

Olivia Burton · +44 20 3448 4531 · olivia.burton7@NHS.net

Huw Morris, MD, PhD

Clinical Aging Research Unit, Newcastle University

Newcastle upon Tyne, England, United Kingdom

Recruiting

Nicola Pavese, MD, PhD, FRCP, FEAN · +44 0191 2081264 · nicola.pavese@ncl.ac.uk

Nicola Pavese, MD, PhD, FRCP, FEAN

Ninewells Hospital and Medical School - NHS Tayside

Dundee, Scotland, United Kingdom

Recruiting

Justine Hudson · +44 1382423086 · justine.hudson2@nhs.scot

Esther Sammler, MD

London North West University Healthcare NHS Trust - Northwick Park Hospital

Harrow, United Kingdom

Not yet recruiting

Tabish Saifee, MBBS, FRCP, PhD · +44 020 3448 4252 · LNWH-tr.Research@nhs.net

Tabish Saifee, MBBS, FRCP, PhD

Panthera Enfield

London, United Kingdom

Not yet recruiting

Karen Faulkner · +44 785 020 8085 · karen.faulkner@panthera-bio.com

Viquar Chamoun, MD

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.