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

About

Brief 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.

Participants will:

Take NEU-411 or placebo every day for 52 weeks

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

40 Years

Maximum Age

80 Years

Inclusion Criteria:

Aged 40-80 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)