NCT06680830 · Neuron23 Inc.
A Phase 2 Study of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
(NEULARK)
What this study is about
The goal of this Phase 2 clinical trial is to investigate the effectiveness 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.
View original scientific description
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.
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
Primary outcome measures
Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placebo
Time frame: From enrollment to the end of treatment at 52 weeks
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo
Time frame: From enrollment to the end of study at 54 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 are outlined in the full study protocol.
Where
- Sun City, Arizona
- Little Rock, Arkansas
- Fresno, California
- Irvine, California
- Los Angeles, California
- Murrieta, California
- Palo Alto, California
- Sacramento, California
- Aurora, Colorado
- Boca Raton, Florida
- Gainesville, Florida
- Orlando, Florida
And 31 more locations — see the full list below.
Collaborators
Qiagen Manchester Limited, Roche Diagnostic Ltd.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations