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

ID#: NCT06680830

Age: 40 - 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 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:

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.
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