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

NCT06680830 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-24

No results posted yet for this study

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

Interventions

DRUG

NEU-411

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

OTHER

Placebo

Orally-administered matched placebo

Sponsors & Collaborators

  • Qiagen Manchester Limited

    collaborator UNKNOWN

  • Roche Diagnostic Ltd.

    collaborator INDUSTRY

  • Neuron23 Inc.

    lead INDUSTRY

Principal Investigators

  • Fatta B Nahab, MD, FAAN FANA · Neuron23 Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-17
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06680830 on ClinicalTrials.gov