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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

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Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Nov 2024

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At a glance

  • Drugs NEU 411 (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Acronyms NEULARK
  • Sponsors Neuron23

    • Most Recent Events

    • 19 Nov 2024 According to a Neuron23 media release, under the collaboration agreement, Roche will provide device hardware and software, site support, and digital biomarker development expertise. Neuron23 will be responsible for all aspects of clinical trial conduct. Financial terms of the agreement were not disclosed.
    • 19 Nov 2024 According to a Neuron23 media release, company announced a collaboration with Roche to incorporate a digital biomarker (once patients will be enrolled in the trial, disease progression will be measured utilizing an innovative digital biomarker) developed by Roche Information Solutions (RIS), the Roche group focused on digital health solutions, as the primary endpoint of NEU-411 in early-stage Parkinsons disease.
    • 19 Nov 2024 According to a Neuron23 media release, Under a separate protocol, Sano will offer saliva test kits that can identify people with LRRK2-driven PD and will provide genetic counseling and engagement tools, including tailored educational content. Individuals identified by Sano Genetics will be referred to the nearest NEULARK clinical trial site for a complete eligibility evaluation and potential enrollment.

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