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NEULARK

  • Status
    Accepting Candidates
  • Age
    40 Years - 80 Years
  • Sexes
    All
  • 网红黑料y Volunteers
    No
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Objective

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:

鈥� Take NEU-411 or placebo every day for 52 weeks

Description

NEU-411-PD201 is a Phase 2, randomized, placebo-controlled, proof-of-concept study in participants with early Parkinson's Disease (PD) who have LRRK2-driven PD as measured by an investigational companion diagnostic genetic test (CDx). The study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NEU-411, an orally-administered, potent, selective, bioavailable, highly permeable, brain penetrant, small molecule inhibitor of LRRK2 activity as compared to placebo.

After participants are screened for inclusion in the study, approximately 150 participants will be randomized in a 1:1 allocation ratio to NEU-411 30 mg once per day or placebo for a 52-week treatment period. A safety follow-up visit will occur 2 weeks after the last treatment visit.

Details

Full study title Neuron23, Inc. / 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)
Protocol number OCR46842
ClinicalTrials.gov ID NCT06680830
Phase Phase 2

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 are outlined in the full study protocol.

Lead researcher

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

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  4. Step
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