A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
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.
Study identifier: NCT06680830. Status: RECRUITING. Phase: PHASE2.
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.
- Minimum age: 40 Years
- Maximum age: 80 Years
Participating locations
- Banner Sun Health Research Institute, Sun City, Arizona
- University of Arkansas, Little Rock, Arkansas
- Neuro-Pain Medical Center, Fresno, California
- University of California, Irvine, Irvine, California
- University of California, Los Angeles, Los Angeles, California
- Esperanza Clinical, Murrieta, California
- Parkinson's Research Centers of America - Palo Alto, Palo Alto, California
- Sutter Neuroscience Institute, Sacramento, California
- University of Colorado - Anschutz Medical Campus, Aurora, Colorado
- Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida
Study records are sourced from ClinicalTrials.gov. Confirm current eligibility, recruiting status, and locations in the official record.