--- title: Slow early Parkinson disease progression nct_id: NCT06680830 phase: PHASE2 status: RECRUITING sponsor: Neuron23 Inc. study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT06680830" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06680830" last_fetched: "2026-05-10T14:08:04.416Z" source: "Parkinson's Pathways (curated)" --- # Slow early Parkinson disease progression **Goal (in five words):** Slow early Parkinson disease progression **Official 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) **Trial ID:** [NCT06680830](https://clinicaltrials.gov/study/NCT06680830) ## Key Facts - **Phase:** PHASE2 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Neuron23 Inc. - **Target Enrollment:** 150 participants - **Start Date:** 2025-01-17 - **Completion Date:** 2026-09 - **Conditions:** Parkinson Disease, Parkinson, Idiopathic Parkinson Disease, Early Parkinson Disease (Early PD), Parkinson Disease, Idiopathic - **Interventions:** NEU-411, Placebo - **Intervention Types:** DRUG, OTHER ## Summary For Families They are testing whether NEU-411 can slow or modify early Parkinson's that is driven by mutations in the LRRK2 gene, by reducing the harmful LRRK2-related processes that may damage nerve cells. NEU-411 is an experimental drug given versus placebo to people who test positive on a companion genetic diagnostic, it is designed to inhibit overactive LRRK2 enzyme activity and would be used alongside standard symptomatic treatments like levodopa rather than replacing them. The trial is looking for adults 40 to 80 years old with clinically established or probable early Parkinson's, Hoehn and Yahr stage 1 to 2.5, who are LRRK2-CDx positive, while excluding atypical parkinsonism, uncontrolled diabetes, and other major medical problems. ## Eligibility - **Minimum age:** 40 Years - **Maximum age:** 80 Years - **Sex:** ALL ### Full Criteria ``` 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. ``` ## Locations (70) - Banner Sun Health Research Institute, Sun City, Arizona, United States _(33.5975, -112.2718)_ - Serena Lowery — (CONTACT) — 623-832-0080 — Serena.Lowery@Bannerhealth.com - David Shprecher, DO — (PRINCIPAL_INVESTIGATOR) - University of Arkansas, Little Rock, Arkansas, United States _(34.7465, -92.2896)_ - Erin Hatcher — (CONTACT) — 501-214-2178 — EHatcher@uams.edu - Rohit Dhall, MD — (PRINCIPAL_INVESTIGATOR) - Neuro-Pain Medical Center, Fresno, California, United States _(36.7477, -119.7724)_ - Mirian Payo — (CONTACT) — 559-437-9700 — mirianp@neuropain.com - Perminder Bhatia, MD — (PRINCIPAL_INVESTIGATOR) - University of California, Irvine, Irvine, California, United States _(33.6695, -117.8231)_ - Rene Anguiano — (CONTACT) — 949-824-6407 — renea1@hs.uci.edu - Sanaz Attaripour Isfahani, MD — (PRINCIPAL_INVESTIGATOR) - University of California, Los Angeles, Los Angeles, California, United States _(34.0522, -118.2437)_ - Diane Yang — (CONTACT) — 310-206-3356 — DDYang@mednet.ucla.edu - Jeff Bronstein, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Esperanza Clinical, Murrieta, California, United States _(33.5539, -117.2139)_ - Esperanza Clinical — (CONTACT) — 951-417-4466 — hello@esperanzaclinical.com - Michael Ropacki, PhD — (PRINCIPAL_INVESTIGATOR) - Parkinson's Research Centers of America - Palo Alto, Palo Alto, California, United States _(37.4419, -122.1430)_ - Leeana Bade — (CONTACT) — 650-394-6690 — Lbade@Parkinsonscenter.org - Salima Brillman, MD — (PRINCIPAL_INVESTIGATOR) - Sutter Neuroscience Institute, Sacramento, California, United States _(38.5816, -121.4944)_ - Sampreet Moneski — (CONTACT) — 916-887-4736 — sampreet.moneski@sutterhealth.org - Nicklesh Thakur, DO — (PRINCIPAL_INVESTIGATOR) - University of Colorado - Anschutz Medical Campus, Aurora, Colorado, United States _(39.7294, -104.8319)_ - Emily Forbes, DO — (CONTACT) — 303-724-4644 — Neuroresearch@cuanschutz.edu - Emily Forbes, DO — (PRINCIPAL_INVESTIGATOR) - Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, United States _(26.3587, -80.0831)_ - Karla Arias — (CONTACT) — 561-392-1818 — karias@parkinsonscenter.org - Stuart Isaacson, MD, FAAN — (PRINCIPAL_INVESTIGATOR) - University of Florida, Gainesville, Florida, United States _(29.6516, -82.3248)_ - Camille Swartz — (CONTACT) — 352-733-2429 — cami.swartz@neurology.ufl.edu - Irene Malaty, MD — (PRINCIPAL_INVESTIGATOR) - Neurology One, Orlando, Florida, United States _(28.5383, -81.3792)_ - Carem Acosta — (CONTACT) — 407-674-1648 — cacosta@neurologyone.com - Ramon L Rodriguez, MD, FAAN — (PRINCIPAL_INVESTIGATOR) - USF Parkinson's & Movement Disorders Clinic, Tampa, Florida, United States _(27.9475, -82.4584)_ - Erica Botting — (CONTACT) — 813-974-8026 — ericabotting@usf.edu - Robert Hauser, MD, MBA, FAAN — (PRINCIPAL_INVESTIGATOR) - Emory University, Atlanta, Georgia, United States _(33.7490, -84.3880)_ - Brian Sperin — (CONTACT) — brian.a.sperin@emory.edu - Stewart Factor, DO — (PRINCIPAL_INVESTIGATOR) - Augusta University, Augusta, Georgia, United States _(33.4710, -81.9748)_ - Buff Farrow — (CONTACT) — 706-721-0619 — BFARROW@augusta.edu - John Morgan, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Northwestern Medical Group, Department of Neurology, Chicago, Illinois, United States _(41.8500, -87.6500)_ - Camryn Butze — (CONTACT) — 312-503-6824 — camryn.butze@northwestern.edu - Danielle N Larson, MD — (PRINCIPAL_INVESTIGATOR) - University of Kansas Medical Center, Kansas City, Kansas, United States _(39.1142, -94.6275)_ - Emily Jackson — (CONTACT) — 913-588-0859 — ejackson9@kumc.edu - Rajesh Pahwa, MD — (PRINCIPAL_INVESTIGATOR) - University of Kentucky, Lexington, Kentucky, United States _(37.9887, -84.4777)_ - Corisa Logan — (CONTACT) — 859-218-5076 — corisa.logan@uky.edu - John Slevin, MD, MBA — (PRINCIPAL_INVESTIGATOR) - Ochsner Clinic Foundation, New Orleans, Louisiana, United States _(29.9547, -90.0751)_ - Anna Leonard-Leumas — (CONTACT) — 504-842-0148 — anna.leonardleumas@ochsner.org - David Houghton, MD — (PRINCIPAL_INVESTIGATOR) - University of Maryland, Baltimore, Maryland, United States _(39.2904, -76.6122)_ - Victoria Davis — (CONTACT) — 410-328-4526 — vdavis@som.umaryland.edu - Joseph Savitt, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States _(42.3584, -71.0598)_ - Alexandra Gottlieb — (CONTACT) — 617-667-9890 — agottli2@bidmc.harvard.edu - Ludy Shih, MD, MMSc — (PRINCIPAL_INVESTIGATOR) - Quest Research Institute, Farmington Hills, Michigan, United States _(42.4853, -83.3772)_ - Nancy Virdi — (CONTACT) — 248-957-8944 — Nancy.Virdi@alcanzaclinical.com - Aaron Ellenbogen, DO, MPH — (PRINCIPAL_INVESTIGATOR) - Struthers Parkinson Center, Golden Valley, Minnesota, United States _(45.0097, -93.3491)_ - Carrie Weaver — (CONTACT) — 952-993-5903 — carrie.a.weaver@healthpartners.com - Sotirios Parashos, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Cleveland Clinic, Las Vegas, Nevada, United States _(36.1750, -115.1372)_ - Liliana Dumitrescu — (CONTACT) — 702-483-6000 — DUMITRL@ccf.org - Zoltan Mari, MD — (PRINCIPAL_INVESTIGATOR) - University of New Mexico, Albuquerque, New Mexico, United States _(35.0845, -106.6511)_ - Anna Tingin — (CONTACT) — 505-272-3342 — atingin@salud.unm.edu - Sarah P Richardson, MD, FAAN — (PRINCIPAL_INVESTIGATOR) - Northwell Health, Great Neck, New York, United States _(40.8007, -73.7285)_ - Nicholas Zumba — (CONTACT) — 516-472-5807 — Neuroscienceresearch@northwell.edu - Ritesh Ramdhani, MD — (PRINCIPAL_INVESTIGATOR) - Icahn School of Medicine at Mount Sinai/Mount Sinai West, New York, New York, United States _(40.7143, -74.0060)_ - Ricardo Renvill — (CONTACT) — 212-844-6055 — ricardo.revill@mountsinai.org - Joohi Jimenez-Shahed, MD — (PRINCIPAL_INVESTIGATOR) - Columbia University, New York, New York, United States _(40.7143, -74.0060)_ - Columbia Movement Disorders Research — (CONTACT) — 347-882-4315 — mdresearch@cumc.columbia.edu - Sheng-Han Kuo, MD — (PRINCIPAL_INVESTIGATOR) - University of Rochester, Rochester, New York, United States _(43.1548, -77.6156)_ - Amy Chesire — (CONTACT) — 585-341-7500 — Amy_Chesire@URMC.Rochester.edu - Christopher Tarolli, MD — (PRINCIPAL_INVESTIGATOR) - University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States _(35.9132, -79.0558)_ - Jessica Ferrall — (CONTACT) — 919-962-8852 — jferrall@neurology.unc.edu - Daniel Roque, MD — (PRINCIPAL_INVESTIGATOR) - The Ohio State University, Columbus, Ohio, United States _(39.9612, -82.9988)_ - Katherine Ambrogi — (CONTACT) — 614-688-6685 — katherine.ambrogi@osumc.edu - Ariane Park, MD, MPH — (PRINCIPAL_INVESTIGATOR) - The Movement Disorder Clinic of Oklahoma, Tulsa, Oklahoma, United States _(36.1540, -95.9928)_ - Elise Gibson — (CONTACT) — 918-392-4530 — mdcclinicaltrials@gmail.com - Kevin Klos, MD — (PRINCIPAL_INVESTIGATOR) - Oregon Health & Science University (OHSU), Portland, Oregon, United States _(45.5234, -122.6762)_ - Emily Leonard — (CONTACT) — 503-367-4719 — leonarde@ohsu.edu - Joseph Quinn, MD — (PRINCIPAL_INVESTIGATOR) - Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States _(39.9524, -75.1636)_ - Brian Urbani — (CONTACT) — 215-955-2635 — Brian.Urbani@jefferson.edu - Tsao-Wei Liang, MD — (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina, Charleston, South Carolina, United States _(32.7763, -79.9327)_ - Robin Bulgarino — (CONTACT) — 843-792-1115 — Bulgarino@musc.edu - Christine Cooper, MD — (PRINCIPAL_INVESTIGATOR) - Vanderbilt University, Nashville, Tennessee, United States _(36.1659, -86.7844)_ - Haley Kling — (CONTACT) — 615-208-3974 — haley.kling@vumc.org - David Charles, MD — (PRINCIPAL_INVESTIGATOR) - Neurology Consultants of Dallas PA, Dallas, Texas, United States _(32.7831, -96.8067)_ - Christina Howell — (CONTACT) — 214-750-9977 — jchowell@neurologydallas.com - Nirav Pavasia, MD — (PRINCIPAL_INVESTIGATOR) - Baylor College of Medicine, Houston, Texas, United States _(29.7633, -95.3633)_ - Aneesch Martin — (CONTACT) — 713-798-2606 — aneesch.martin@bcm.edu - Arjun Tarakad, MD — (PRINCIPAL_INVESTIGATOR) - The University of Texas Health Science Center at Houston, Houston, Texas, United States _(29.7633, -95.3633)_ - Brittany Duncan — (CONTACT) — 713-486-3134 — Brittany.J.Duncan@uth.tmc.edu - Raja Mehanna, MD — (PRINCIPAL_INVESTIGATOR) - Central Texas Neurology Consultants, Round Rock, Texas, United States _(30.5083, -97.6789)_ - Koni Lopez — (CONTACT) — 512-218-1222 — k.lopez@ctncpa.org - Elizabeth Peckham, DO — (PRINCIPAL_INVESTIGATOR) - University of Utah Movement Division, Salt Lake City, Utah, United States _(40.7608, -111.8911)_ - Kendra Fowler — (CONTACT) — 801-581-7828 — kendra.fowler@utah.edu - Paolo Moretti, MD — (PRINCIPAL_INVESTIGATOR) - University of Virginia, Charlottesville, Virginia, United States _(38.0293, -78.4767)_ - Lauren Miller — (CONTACT) — 434-982-6599 — FDK5DN@UVAHealth.org - Binit Shah, MD, FAAN — (PRINCIPAL_INVESTIGATOR) - EvergreenHealth, Kirkland, Washington, United States _(47.6815, -122.2087)_ - Gowri Rajendran — (CONTACT) — 425-899-5370 — grajendran@evergreenhealthcare.org - Pinky Agarwal, MD, FAAN — (PRINCIPAL_INVESTIGATOR) - Inland Northwest Research, Spokane, Washington, United States _(47.6597, -117.4291)_ - Michael Dauer — (CONTACT) — 509-960-2818 — mdauer@inwresearch.com - Jason Aldred, MD — (PRINCIPAL_INVESTIGATOR) - Medical College of Wisconsin, Milwaukee, Wisconsin, United States _(43.0389, -87.9065)_ - Shelby Schold — (CONTACT) — 414-955-0698 — sschold@mcw.edu - Karen Blindauer, MD — (PRINCIPAL_INVESTIGATOR) - Rambam Medical Center, Haifa, Israel _(32.8130, 34.9993)_ - Ilana Schlesinger, MD, Prof — (CONTACT) — 972-4-7771495 — i_schles@rmc.gov.il - Ilana Schlesinger, MD, Prof — (PRINCIPAL_INVESTIGATOR) - Shaare Zedek Medical Center, Jerusalem, Israel _(31.7690, 35.2163)_ - Yael Mimoun — (CONTACT) — 972-5-43184600 — yaelmi@szmc.org.il - Gilad Yahalom, MD, Prof — (PRINCIPAL_INVESTIGATOR) - Sheba Medical Center, Ramat Gan, Israel _(32.0823, 34.8107)_ - Adi Saar — (CONTACT) — 972-3-5304931 — adi.saar@sheba.health.gov.il - Sharon Hassin, MD, Prof — (PRINCIPAL_INVESTIGATOR) - Tel Aviv Medical Center, Tel Aviv, Israel _(32.0809, 34.7806)_ - Adi Ezra — (CONTACT) — 972-3-6974912 — adil@tlvmc.gov.il - Tanya Gurevich, MD, Prof — (PRINCIPAL_INVESTIGATOR) - IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia, Milan, Italy _(42.7824, 12.5984)_ - Daniela Capilupo — (CONTACT) — +39 0226434815 — capilupo.daniela@hsr.it - Massimo Filippi, MD, Prof — (PRINCIPAL_INVESTIGATOR) - Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria, Naples, Italy _(40.8522, 14.2681)_ - Teresa Del Santo — (CONTACT) — +39 3494026479 — delsantoteresa@gmail.com - Alessandro Tessitore, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica, Padua, Italy _(45.4080, 11.8859)_ - Angelo Antonini — (CONTACT) — +39 0498213607 — angelo.antonini.pd@gmail.com - Angelo Antonini, MD, PhD, Prof — (PRINCIPAL_INVESTIGATOR) - Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara, Pisa, Italy _(43.7085, 10.4036)_ - Pierangela Riani — (CONTACT) — +39 050992567 — p.riani@ao-pisa.toscana.it - Roberta Ceravolo, MD, Prof — (PRINCIPAL_INVESTIGATOR) - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana, Rome, Italy _(41.8919, 12.5113)_ - Miriam Casali — (CONTACT) — +39 0652252311 — miriam.casali@sanraffaele.it - Fabrizio Stocchi, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Fondazione Policilinico Universitario A Gemelli IRCCS, Rome, Italy _(41.8919, 12.5113)_ - Flavia Torlizzi — (CONTACT) — +39 0630155633 — flavia.torlizzi@policlinicogemelli.it - Anna Rita Bentivoglio, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Centrum Medyczne Neuromed, Bydgoszcz, Poland _(53.1235, 18.0076)_ - Beata Lisewska — (CONTACT) — +48 696268565 — lisewskabeata@gmail.com - Pawel Lisewski, MD — (PRINCIPAL_INVESTIGATOR) - NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski, Katowice, Poland _(50.2597, 19.0217)_ - Katarzyna Smilowska — (CONTACT) — +48 600282870 — kasia.smilowska@gmail.com - Katarzyna Smilowska, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Pro Life Medica Sp. z o. o. ETA Lublin, Lublin, Poland _(51.2506, 22.5701)_ - Dominika Tomaka, MD — (CONTACT) — +48 691485946 — d.tomaka@etg-network.org - Dominika Tomaka, MD — (PRINCIPAL_INVESTIGATOR) - Insula Badania Sp. Z o.o., Warsaw, Poland _(52.2298, 21.0118)_ - Marta Jethon — (CONTACT) — +48 501035250 — jethon2@tlen.pl - Marta Jethon, MD — (PRINCIPAL_INVESTIGATOR) - Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP), San Sebastián, Donostia, Spain _(43.5667, -5.9000)_ - Gurutz Linazasoro, MD — (CONTACT) — +34 943002812 — glinazasoro@vivebiotech.com - Gurutz Linazasoro, MD — (PRINCIPAL_INVESTIGATOR) - Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces, Barakaldo, Spain _(43.2964, -2.9881)_ - Naiara Azcue — (CONTACT) — +34 944881576 — azkue.naiara@gmail.com - Juan Carlos Gomez Esteban, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Hospital Universitari Vall d'Hebron, Barcelona, Spain _(41.3888, 2.1590)_ - Jorge Hernandez Vara, MD — (CONTACT) — +34 934893000 — jorge.hernandez@vallhebron.cat - Jorge Hernandez Vara, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A., Barcelona, Spain _(41.3888, 2.1590)_ - Alicia Garrido, Pla — (CONTACT) — +34 932275785 — agarridop@clinic.cat - Alicia Garrido, Pla — (PRINCIPAL_INVESTIGATOR) - Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa, Madrid, Spain _(40.4165, -3.7026)_ - Lydia Lopez Manzanares — (CONTACT) — +34 915202405 — lydia.lopez@salud.madrid.org - Lydia Lopez Manzanares, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Universitario HM Puerta del Sur, Móstoles, Spain _(40.3223, -3.8650)_ - Patricia Vicente — (CONTACT) — +34 912673100 — pvicentefernandez@hmhospitales.com - Michele Matarazzo, MD — (PRINCIPAL_INVESTIGATOR) - Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS), Seville, Spain _(37.3828, -5.9732)_ - Pablo Mir, MD — (CONTACT) — +34 955923039 — pmir@us.es - Pablo Mir, MD — (PRINCIPAL_INVESTIGATOR) - St George's Hospital, University of London, London, England, United Kingdom _(51.5085, -0.1257)_ - Francesca Morgante, MD — (CONTACT) — +44 20 8725 5403 — fmorgant@sgul.ac.uk - Francesca Morgante, MD — (PRINCIPAL_INVESTIGATOR) - University College London Hospitals NHS Foundation Trust, London, England, United Kingdom _(51.5085, -0.1257)_ - Olivia Burton — (CONTACT) — +44 20 3448 4531 — olivia.burton7@NHS.net - Huw Morris, MD, PhD — (PRINCIPAL_INVESTIGATOR) - Clinical Aging Research Unit, Newcastle University, Newcastle upon Tyne, England, United Kingdom _(54.9733, -1.6140)_ - Nicola Pavese, MD, PhD, FRCP, FEAN — (CONTACT) — +44 0191 2081264 — nicola.pavese@ncl.ac.uk - Nicola Pavese, MD, PhD, FRCP, FEAN — (PRINCIPAL_INVESTIGATOR) - Ninewells Hospital and Medical School - NHS Tayside, Dundee, Scotland, United Kingdom _(56.4691, -2.9749)_ - Justine Hudson — (CONTACT) — +44 1382423086 — justine.hudson2@nhs.scot - Esther Sammler, MD — (PRINCIPAL_INVESTIGATOR) ## Central Contacts - Fatta B Nahab, MD, FAAN, FANA — (CONTACT) — 650-228-2527 — clinicaltrials@neuron23.com --- *Canonical: https://parkinsonspathways.com/trial/NCT06680830* *HTML version: https://parkinsonspathways.com/trial/NCT06680830* *Source data: https://clinicaltrials.gov/study/NCT06680830*