Recruiting

NEULARKNEU-411 for Early Parkinson's Disease with LRRK2 Mutation

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What is being tested

NEU-411

+ Placebo

DrugOther
Who is being recruted

Synucleinopathies+6

+ Basal Ganglia Diseases

+ Brain Diseases

From 40 to 80 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorNeuron23 Inc.
Study ContactFatta B Nahab, MD, FAAN, FANA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 17, 2025

Actual date on which the first participant was enrolled.

This study is focused on finding out if a new medicine called NEU-411 can help people with early Parkinson's Disease, specifically those with a genetic form of the disease known as LRRK2-driven PD. By using a special genetic test, the study aims to select participants who might benefit the most from this treatment. The research is important because it could lead to better treatments for those with this specific type of Parkinson's Disease, potentially slowing its progression or improving symptoms. Participants in the study will either receive NEU-411 or a placebo, which is a substance with no active medical effect, for a year. The medicine is taken by mouth once a day. Throughout the study, researchers will monitor the safety of NEU-411, as well as how it moves and acts in the body. After completing the treatment period, participants will have a follow-up visit to ensure their well-being. This study does not specify any potential risks or benefits, but it aims to collect important data on how effective and safe NEU-411 is for treating early Parkinson's Disease.

Official TitleA Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
NCT06680830
Principal SponsorNeuron23 Inc.
Study ContactFatta B Nahab, MD, FAAN, FANA
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

150 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement DisordersNervous System DiseasesParkinson DiseaseNeurodegenerative DiseasesParkinsonian Disorders

Criteria

4 inclusion criteria required to participate
Modified Hoehn and Yahr (mH&Y) of 1 to 2.5
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)
3 exclusion criteria prevent from participating
Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
Secondary or atypical parkinsonian syndromes
Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Orally-administered NEU-411

Group II

Placebo
Orally-administered matching placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 64 locations

Recruiting

Oregon Health & Science University (OHSU)

Portland, United StatesOpen Oregon Health & Science University (OHSU) in Google Maps
Recruiting

Medical University of South Carolina

Charleston, United States
Recruiting

Vanderbilt University

Nashville, United States
Recruiting

Baylor College of Medicine

Houston, United States
Recruiting
64 Study Centers