A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease (NEULARK)
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
Parkinson’s Foundation PD GENEration Genetic Registry
Study sponsor: Parkinson’s Foundation
Location: Struthers Parkinson’s Center
Purpose of study: Purpose: to help improve our understanding of Parkinson’s Disease and help participants and their clinicians understand their genetic status to improve care, which includes determining eligibility for clinical trial participation. Study includes a baseline visit (in-person or by video) and a genetic counseling visit (by video, phone, or in-person) to discuss your test results with the study doctor.
Inclusion Criteria:
– Diagnosis, or probable diagnosis, for Parkinson’s Disease.
– Capacity to give full informed consent.
– Participant must have residential address in MN or Wisconsin.
Exclusion Criteria:
– Received a blood transfusion within the past 3 months.
– Received a bone marrow transplant within the past 5 years.
– Active blood cancer, such as lymphoma or leukemia.
– Under the age of 18.
Study Contact
Taylor Billeadeau
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04994015
