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

ID#: NCT06680830

Age: 50 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: January 17, 2025

End Date: September 01, 2027

Contact Information:
Fatta B Nahab, MD, FAAN, FANA
650-228-2527
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:

Inclusion Criteria:

1. Aged 50-80 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 are outlined in the full study protocol.
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