|

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

RECRUITINGPhase 2Sponsored by Neuron23 Inc.
Actively Recruiting
PhasePhase 2
SponsorNeuron23 Inc.
Started2025-01-17
Est. completion2026-09
Eligibility
Age40 Years – 80 Years
Healthy vol.Accepted
Locations44 sites
View on ClinicalTrials.gov →

NCT06680830

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.

Eligibility

Age: 40 Years – 80 YearsHealthy volunteers accepted
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.

Conditions6

Early Parkinson Disease (Early PD)Idiopathic Parkinson DiseaseParkinsonParkinson DiseaseParkinson Disease, IdiopathicParkinson's Disease

Locations44 sites

Banner Sun Health Research Institute
Sun City, Arizona, 85351
Serena Lowery623-832-0080Serena.Lowery@Bannerhealth.com
University of Arkansas
Little Rock, Arkansas, 72205
Erin Hatcher501-214-2178EHatcher@uams.edu
Neuro-Pain Medical Center
Fresno, California, 93710
Mirian Payo559-437-9700mirianp@neuropain.com
University of California, Irvine
Irvine, California, 92697
Rene Anguiano949-824-6407renea1@hs.uci.edu
University of California, Los Angeles
Los Angeles, California, 90095
Diane Yang310-206-3356DDYang@mednet.ucla.edu

Browse More Trials

Parkinson's Disease trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.