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

Launched by NEURON23 INC. · Nov 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NEU-411 for people aged 50 to 80 who have early Parkinson's Disease (PD) and have a specific genetic profile that suggests their symptoms may be linked to a pathway called LRRK2. The goal is to see if NEU-411 is safe and effective for these patients. To participate, individuals must have a confirmed diagnosis of early PD, and they will need to take a DNA test to confirm they have LRRK2-driven PD.

Participants in this study will take either NEU-411 or a placebo (a look-alike pill that does not contain the active medication) every day for a year. To be eligible, participants should have a mild to moderate stage of Parkinson's Disease, with a certain score on a scale that measures the severity of their symptoms. It’s important to note that those with other types of Parkinson’s or serious health issues may not qualify for this trial. If you or someone you know is interested in participating, it could provide an opportunity to explore a new treatment option while contributing to important research.

Gender

ALL

Eligibility criteria

• 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.