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
- Albuquerque, Atlanta, Augusta, Aurora, Baltimore, Boca Raton, Boston, Chapel Hill, Charleston, Charlottesville, Chicago, Columbus, Dallas, Farmington Hills, Fresno, Gainesville, Golden Valley, Houston, Irvine, Kansas City, Kirkland, Las Vegas, Lexington, Little Rock, Los Angeles, Manhasset, Milwaukee, Murrieta, Nashville, New Orleans, New York, Orlando, Palo Alto, Philadelphia, Portland, Rochester, Round Rock, Sacramento, Salt Lake City, Spokane, Sun City, Tampa, and Tulsa, United StatesSee the 45 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 United States
- University of New MexicoAlbuquerque, United StatesTaking people
- Emory UniversityAtlanta, United StatesTaking people
- Augusta UniversityAugusta, United StatesTaking people
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
- University of MarylandBaltimore, United StatesTaking people
- Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, United StatesTaking people
- Beth Israel Deaconess Medical CenterBoston, United StatesTaking people
- University of North Carolina, Chapel HillChapel Hill, United StatesTaking people
- Medical University of South CarolinaCharleston, United StatesTaking people
- University of VirginiaCharlottesville, United StatesTaking people
- Northwestern Medical Group, Department of NeurologyChicago, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- Neurology Consultants of Dallas, PADallas, United StatesTaking people
- QUEST Research InstituteFarmington Hills, United StatesTaking people
- Neuro-Pain Medical CenterFresno, United StatesTaking people
- University of FloridaGainesville, United StatesTaking people
- Struthers Parkinson CenterGolden Valley, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- The University of Texas Health Science Center at HoustonHouston, United StatesTaking people
- University of California, IrvineIrvine, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- EvergreenHealthKirkland, United StatesTaking people
- Cleveland ClinicLas Vegas, United StatesTaking people
- University of KentuckyLexington, United StatesTaking people
- University of ArkansasLittle Rock, United StatesTaking people
- University of California, Los AngelesLos Angeles, United StatesTaking people
- Northwell HealthManhasset, United StatesTaking people
- Medical College of WisconsinMilwaukee, United StatesTaking people
- Esperanza ClinicalMurrieta, United StatesNo longer taking part
- Vanderbilt UniversityNashville, United StatesTaking people
- Ochsner Clinic FoundationNew Orleans, United StatesTaking people
- Columbia UniversityNew York, United StatesTaking people
- Icahn School of Medicine at Mount Sinai/Mount Sinai WestNew York, United StatesTaking people
- Neurology OneOrlando, United StatesTaking people
- Parkinson?s Research Centers of America ? Palo AltoPalo Alto, United StatesTaking people
- Thomas Jefferson University HospitalPhiladelphia, United StatesTaking people
- Oregon Health & Science University (OHSU)Portland, United StatesTaking people
- University of RochesterRochester, United StatesTaking people
- Central Texas Neurology ConsultantsRound Rock, United StatesTaking people
- Sutter Neuroscience InstituteSacramento, United StatesTaking people
- University of Utah Movement DivisionSalt Lake City, United StatesTaking people
- Inland Northwest ResearchSpokane, United StatesTaking people
- Banner Sun Health Research InstituteSun City, United StatesTaking people
- USF Parkinson's & Movement Disorders ClinicTampa, United StatesTaking people
- The Movement Disorder Clinic of OklahomaTulsa, United StatesTaking 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%.