Phase 2 Study of NEU-411 for Early Parkinson's Disease
This Phase 2 study is testing a drug called NEU-411 for people with early Parkinson's Disease (PD). NEU-411 is designed to block the activity of a protein called LRRK2, which is thought to play a role in some forms of PD. To join, you must be between 40 and 80 years old, have early PD, and a genetic test must show you have "LRRK2-driven" PD. Researchers will compare NEU-411 to a placebo (an inactive substance) to see if it improves symptoms measured by a special app and to check for any side effects. The study aims to enroll about 150 participants, but its current status is unclear.
- Study design
- This is a Phase 2, randomized, placebo-controlled study with an open-label extension, meaning some participants will receive NEU-411 and others a placebo, and then some may continue with NEU-411. Approximately 150 participants will be enrolled.
- What's involved
- Participants will receive treatment for 52 weeks, followed by a safety check-up within two weeks. Eligible participants may then join an open-label extension for an additional 26 weeks of treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety for up to 54 weeks from enrollment, which includes a follow-up visit within two weeks after the last treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
At a glance
Conditions
NCT06680830
Where you'd take part
This study runs at 72 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Augusta University
Augusta, Georgiastudy coordinator listed
Recruiting
Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara
Pisa, Italystudy coordinator listed
Recruiting
Banner Sun Health Research Institute
Sun City, Arizonastudy coordinator listed
Recruiting
Baylor College of Medicine
Houston, Texasstudy coordinator listed
Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusettsstudy coordinator listed
Recruiting
Central Texas Neurology Consultants
Round Rock, Texasstudy coordinator listed
Recruiting
Centrum Medyczne Neuromed
Bydgoszcz, Polandstudy coordinator listed
Recruiting
Cleveland Clinic
Las Vegas, Nevadastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Fatta B Nahab, MD, FAAN FANA · PRINCIPAL_INVESTIGATOR · Neuron23 Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change from baseline in the Roche digital biomarker score using the Roche Parkinson's Disease application (v3.0) compared to placeboFrom enrollment to the end of treatment at 52 weeks
- Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placeboFrom enrollment to the end of study at 54 weeks