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RecruitingPhase 2

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

Neuron23 Inc. · with Qiagen Manchester Limited, Roche Diagnostic Ltd. · NCT06680830

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–80 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
150
US sites recruiting
44
Study start
January 17, 2025
Record last updated
October 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: NEU-411; Placebo

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Recruiting US locations

  • Banner Sun Health Research Institute

    Sun City, AZ 85351

    Site contact: Serena Lowery · 623-832-0080 · Serena.Lowery@Bannerhealth.com

  • University of Arkansas

    Little Rock, AR 72205

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

  • Neuro-Pain Medical Center

    Fresno, CA 93710

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

  • University of California, Irvine

    Irvine, CA 92697

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

  • University of California, Los Angeles

    Los Angeles, CA 90095

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

  • Parkinson's Research Centers of America - Palo Alto

    Palo Alto, CA 94301

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

  • Sutter Neuroscience Institute

    Sacramento, CA 95816

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

  • University of Colorado - Anschutz Medical Campus

    Aurora, CO 80045

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

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, FL 33486

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

  • University of Florida

    Gainesville, FL 32608

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

  • Neurology One

    Orlando, FL 32825

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

  • USF Parkinson's & Movement Disorders Clinic

    Tampa, FL 33613

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

  • Emory University

    Atlanta, GA 30329

    Site contact: Brian Sperin · brian.a.sperin@emory.edu

  • Augusta University

    Augusta, GA 30912

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

  • Northwestern Medical Group, Department of Neurology

    Chicago, IL 60611

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

  • University of Kansas Medical Center

    Kansas City, KS 66160

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

  • University of Kentucky

    Lexington, KY 40536

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

  • Ochsner Clinic Foundation

    New Orleans, LA 70121

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

  • University of Maryland

    Baltimore, MD 21201

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

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

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

  • Quest Research Institute

    Farmington Hills, MI 48334

    Site contact: Nancy Virdi · 248-957-8944 · Nancy.Virdi@alcanzaclinical.com

  • Struthers Parkinson Center

    Golden Valley, MN 55427

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

  • Cleveland Clinic

    Las Vegas, NV 89106

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

  • University of New Mexico

    Albuquerque, NM 87106

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

  • Northwell Health

    Manhasset, NY 11030

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

  • Icahn School of Medicine at Mount Sinai/Mount Sinai West

    New York, NY 10019

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

  • Columbia University

    New York, NY 10032

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

  • University of Rochester

    Rochester, NY 14618

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

  • University of North Carolina - Chapel Hill

    Chapel Hill, NC 27599

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

  • The Ohio State University

    Columbus, OH 43210

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

  • The Movement Disorder Clinic of Oklahoma

    Tulsa, OK 74136

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

  • Oregon Health & Science University (OHSU)

    Portland, OR 97239

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

  • Thomas Jefferson University Hospital

    Philadelphia, PA 19107

    Site contact: Brian Urbani · 215-955-2635 · Brian.Urbani@jefferson.edu

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Robin Bulgarino · 843-792-1115 · Bulgarino@musc.edu

  • Vanderbilt University

    Nashville, TN 37232

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

  • Neurology Consultants of Dallas PA

    Dallas, TX 75243

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

  • Baylor College of Medicine

    Houston, TX 77030

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

  • The University of Texas Health Science Center at Houston

    Houston, TX 77030

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

  • Central Texas Neurology Consultants

    Round Rock, TX 78681

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

  • University of Utah Movement Division

    Salt Lake City, UT 84108

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

  • University of Virginia

    Charlottesville, VA 22903

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

  • EvergreenHealth

    Kirkland, WA 98034

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

  • Inland Northwest Research

    Spokane, WA 99202

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

  • Medical College of Wisconsin

    Milwaukee, WI 53226

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

Study contacts (from the official record)

  • Fatta B Nahab, MD, FAAN, FANA · 650-228-2527 · clinicaltrials@neuron23.com
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A Phase 2 Study and Open-Label Extension of NEU-411 in Companion… (NCT06680830) | Bored Studies