Tests NEU-411 in early Parkinson's disease with a specific genetic profile
Tests NEU-411 against placebo in adults with early Parkinson's disease and a genetic marker.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
Key facts
- Where
- Brescia, Catania, Chieti Scalo, Milano, Naples, Padova, Pisa, Pozzilli, and Rome, ItalySee the 10 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 80 years old?
Source: NCT06680830, who can take part
Where in Italy
- ASST Spedali Civili di BresciaBrescia, ItalyTaking people
- AOU Policlinico-San MarcoCatania, ItalyTaking people
- Universita' Degli Studi G. D'Annunzio Di ChietiChieti Scalo, ItalyTaking people
- IRCCS - Ospedale San RaffaeleMilano, ItalyTaking people
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyTaking people
- Universita Degli Studi Di PadovaPadova, ItalyTaking people
- Ospedale Santa ChiaraPisa, ItalyTaking people
- Istituto Neurologico Mediterraneo Neuromed S.p.A.Pozzilli, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
- Irccs San Raffaele Roma S.r.l.Rome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Neuron23 Inc.
- Trial code
- NCT06680830EU 2024-515448-22-00
- Record updated
- 30 October 2026
- Original 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.Read full original descriptionShow less
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study and Open-Label Extension to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease (NEULARK)
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.
Inclusion: 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); Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5.
Exclusion: Secondary or atypical parkinsonian syndromes; 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; Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%.