NCT06680830 A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
| NCT ID | NCT06680830 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Neuron23 Inc. |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-01-17 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-01-17 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Fatta B Nahab, MD, FAAN FANA
PRINCIPAL INVESTIGATOR
Neuron23 Inc.
Frequently Asked Questions
Who can join the NCT06680830 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06680830 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06680830 currently recruiting?
Yes, NCT06680830 is actively recruiting participants. Contact the research team at clinicaltrials@neuron23.com for enrollment information.
Where is the NCT06680830 trial being conducted?
This trial is being conducted at Sun City, United States, Little Rock, United States, Fresno, United States, Irvine, United States and 11 additional locations.
Who is sponsoring the NCT06680830 clinical trial?
NCT06680830 is sponsored by Neuron23 Inc.. The principal investigator is Fatta B Nahab, MD, FAAN FANA at Neuron23 Inc.. The trial plans to enroll 150 participants.
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