Actively Recruiting

Phase 2
Age: 40Years - 80Years
All Genders
NCT06680830

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

Led by Neuron23 Inc. · Updated on 2026-04-24

150

Participants Needed

70

Research Sites

136 weeks

Total Duration

On this page

Sponsors

N

Neuron23 Inc.

Lead Sponsor

Q

Qiagen Manchester Limited

Collaborating Sponsor

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 40-80 years at time of screening, inclusive
  • Diagnosis of clinically established or clinically probable Parkinson's Disease
  • LRRK2-driven Parkinson's Disease confirmed by investigational companion diagnostic genetic test
  • Modified Hoehn and Yahr stage of 1 to 2.5
Not Eligible

You will not qualify if you...

  • Secondary or atypical parkinsonian syndromes
  • Uncontrolled diabetes mellitus with hemoglobin A1c greater than 8%
  • Other significant medical conditions as determined by medical history, examination, or clinical investigations at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 70 locations

1

Banner Sun Health Research Institute

Sun City, Arizona, United States, 85351

Actively Recruiting

2

University of Arkansas

Little Rock, Arkansas, United States, 72205

Actively Recruiting

3

Neuro-Pain Medical Center

Fresno, California, United States, 93710

Actively Recruiting

4

University of California, Irvine

Irvine, California, United States, 92697

Actively Recruiting

5

University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

6

Esperanza Clinical

Murrieta, California, United States, 92562

Actively Recruiting

7

Parkinson's Research Centers of America - Palo Alto

Palo Alto, California, United States, 94301

Actively Recruiting

8

Sutter Neuroscience Institute

Sacramento, California, United States, 95816

Actively Recruiting

9

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

10

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States, 33486

Actively Recruiting

11

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

12

Neurology One

Orlando, Florida, United States, 32825

Actively Recruiting

13

USF Parkinson's & Movement Disorders Clinic

Tampa, Florida, United States, 33613

Actively Recruiting

14

Emory University

Atlanta, Georgia, United States, 30329

Actively Recruiting

15

Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

16

Northwestern Medical Group, Department of Neurology

Chicago, Illinois, United States, 60611

Actively Recruiting

17

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

18

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

19

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

Actively Recruiting

20

University of Maryland

Baltimore, Maryland, United States, 21201

Actively Recruiting

21

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

22

Quest Research Institute

Farmington Hills, Michigan, United States, 48334

Actively Recruiting

23

Struthers Parkinson Center

Golden Valley, Minnesota, United States, 55427

Actively Recruiting

24

Cleveland Clinic

Las Vegas, Nevada, United States, 89106

Actively Recruiting

25

University of New Mexico

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

26

Northwell Health

Great Neck, New York, United States, 11021

Actively Recruiting

27

Icahn School of Medicine at Mount Sinai/Mount Sinai West

New York, New York, United States, 10019

Actively Recruiting

28

Columbia University

New York, New York, United States, 10032

Actively Recruiting

29

University of Rochester

Rochester, New York, United States, 14618

Actively Recruiting

30

University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

31

The Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

32

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States, 74136

Actively Recruiting

33

Oregon Health & Science University (OHSU)

Portland, Oregon, United States, 97239

Actively Recruiting

34

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

35

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

36

Vanderbilt University

Nashville, Tennessee, United States, 37232

Actively Recruiting

37

Neurology Consultants of Dallas PA

Dallas, Texas, United States, 75243

Not Yet Recruiting

38

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

39

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

40

Central Texas Neurology Consultants

Round Rock, Texas, United States, 78681

Actively Recruiting

41

University of Utah Movement Division

Salt Lake City, Utah, United States, 84108

Actively Recruiting

42

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

43

EvergreenHealth

Kirkland, Washington, United States, 98034

Actively Recruiting

44

Inland Northwest Research

Spokane, Washington, United States, 99202

Actively Recruiting

45

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

46

Rambam Medical Center

Haifa, Israel, 3109601

Not Yet Recruiting

47

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Not Yet Recruiting

48

Sheba Medical Center

Ramat Gan, Israel, 5262000

Not Yet Recruiting

49

Tel Aviv Medical Center

Tel Aviv, Israel, 6423906

Not Yet Recruiting

50

IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia

Milan, Italy, 20132

Not Yet Recruiting

51

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

Naples, Italy, 80138

Actively Recruiting

52

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

Padua, Italy, 35128

Actively Recruiting

53

Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara

Pisa, Italy, 56126

Not Yet Recruiting

54

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

Rome, Italy, 00166

Not Yet Recruiting

55

Fondazione Policilinico Universitario A Gemelli IRCCS

Rome, Italy, 00168

Actively Recruiting

56

Centrum Medyczne Neuromed

Bydgoszcz, Poland, 85-163

Not Yet Recruiting

57

NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski

Katowice, Poland, 32-600

Not Yet Recruiting

58

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

Lublin, Poland, 20-412

Not Yet Recruiting

59

Insula Badania Sp. Z o.o.

Warsaw, Poland, 02-699

Not Yet Recruiting

60

Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP)

San Sebastián, Donostia, Spain, 20014

Actively Recruiting

61

Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces

Barakaldo, Spain, 49003

Not Yet Recruiting

62

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

63

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

Barcelona, Spain, 08036

Actively Recruiting

64

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

Madrid, Spain, 28006

Actively Recruiting

65

Hospital Universitario HM Puerta del Sur

Móstoles, Spain, 28938

Actively Recruiting

66

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

Seville, Spain, 41013

Actively Recruiting

67

St George's Hospital, University of London

London, England, United Kingdom, SW17 0QT

Actively Recruiting

68

University College London Hospitals NHS Foundation Trust

London, England, United Kingdom, WC1N 3BG

Actively Recruiting

69

Clinical Aging Research Unit, Newcastle University

Newcastle upon Tyne, England, United Kingdom, NE4 5PL

Actively Recruiting

70

Ninewells Hospital and Medical School - NHS Tayside

Dundee, Scotland, United Kingdom, DD19SY

Actively Recruiting

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Research Team

F

Fatta B Nahab, MD, FAAN, FANA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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