Principal Investigator:
Study sponsor: Neuron23, Inc.
Location: Struthers Parkinson’s Center
Phase of Study: II
Purpose of study: This is a randomized, placebo-controlled, study in participants with early PD who have elevated leucine-rich repeat kinase 2 (LRRK2)-pathway activity assessed using a co-developed investigational CDx. Only participants who test positive using the investigational CDx will be included in the study, including both individuals with rare variants and others with predicted elevations in LRRK2 activity. The study will evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of orally administered NEU-411, a study drug as compared to placebo.
Inclusion Criteria:
– The participant must test positive (LRRK2-driven) using the investigational CDx performed at the designated central laboratory
– Aged 50-80 years at time of Screening
– Participants are not currently on nor anticipated to require dopaminergic therapy (e.g., levodopa) within the next 12 months
– Participants who have a body mass index (BMI) of 18-32 kg/m2
Exclusion Criteria:
– Parkinsonian syndromes due to a secondary etiology, including parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body (LB) dementia
– Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
– Reside in a skilled nursing facility
Study Contact:
Carrie Weaver
(651) 495-6363
ClinicalTrials@HealthPartners.com
