ClinicalTrials.gov ID: NCT06680830
Ages Eligible: 50 Years to 80 Years
Sexes Eligible: All
Study Phase: Interventional
Study Completion (Estimated): 2027-09
Principal Investigator: Pinky Agarwal, MD, FAAN
Contact Information:
EvergreenHealth Research Department
425-899-5385
EvergreenResearch@evergreenhealthcare.org
Summary:
The goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 50-80 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. Participants will take NEU-411 or placebo every day for 52 weeks
Eligibility Criteria:
Inclusion Criteria
- Aged 50-80 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 Criteria
- Secondary or atypical parkinsonian syndromes
- Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
- Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening)
Additional inclusion and exclusion criteria are outlined in the full study protocol.
