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A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease

NCT06680830

RecruitingPhase 2

Sponsor: Neuron23 Inc.

Conditions: Parkinson Disease, Parkinson, Idiopathic Parkinson Disease, Early Parkinson Disease (Early PD), Parkinson Disease, Idiopathic

Interventions: NEU-411, Placebo

Countries: United States, Israel, Italy, Poland, Spain, United Kingdom

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 overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (70)
  • Sun City, Arizona, United States
  • Little Rock, Arkansas, United States
  • Fresno, California, United States
  • Irvine, California, United States
  • Los Angeles, California, United States
  • Murrieta, California, United States
  • Palo Alto, California, United States
  • Sacramento, California, United States
  • Aurora, Colorado, United States
  • Boca Raton, Florida, United States
  • Gainesville, Florida, United States
  • Orlando, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Augusta, Georgia, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • Lexington, Kentucky, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Farmington Hills, Michigan, United States
  • Golden Valley, Minnesota, United States
  • Las Vegas, Nevada, United States
  • Albuquerque, New Mexico, United States
  • Manhasset, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Chapel Hill, North Carolina, United States
  • + 40 more on CT.gov