A Phase 2 Study of NEU-411 in CDx-Positive Participants with Early Parkinson’s Disease

• Research type

  Research Study

• Full title

  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)

• IRAS ID

  1011815

• Contact name

  Fatta Nahab MD

• Contact email

  clinicaltrials@neuron23.com

• Sponsor organisation

  Neuron23, Inc.

• Clinicaltrials.gov Identifier

  NCT06680830

• Research summary

  The aim of the study is to assess the safety and efficacy of a new drug called NEU-411, compared to a placebo, for the treatment of early Parkinson's Disease (PD). The study will enrol individuals who are untreated or treated only with a stable dose of monoamine oxidase-B (MAO-B) inhibitor for at least 30 days prior to the start of the study and who are not expected to require dopaminergic therapy for the duration of the study. Patients will be screened, and only those who have increased LRRK2 gene activity will be enrolled in the main study. The participants must test positive (LRRK2-driven) using the investigational CDx test; Individuals enrolling in the study will have to follow an initial 30-day run-in period with the Roche PD Mobile Application on a pre-configured smartphone while wearing an Actigraph smartwatch. NEU-411 is a new class of drug that inhibits the enzyme function of the LRRK kinase. Inhibition of LRRK may slow, prevent, and/or reverse the LRRK2 processes causing disease in patients with PD. This study is a phase 2, randomised, double blind, placebo controlled trial. Participants will be randomised to the treatment arms and will receive NEU-411 or placebo tablets once daily for 52 weeks. During the study, participants will visit the study site about 21 times over an estimated 67-week period. Once the treatment is complete, a safety follow-up visit will occur. The following study procedures will be performed: (a) physical examinations (b) ECGs (c) blood tests (d) urine tests (e) DaT-SPECT, a brain MRI and CT scans (f) LRRK gene test (g) drug administration (h) study drug blood level tests and (i) a variety of questionnaires and (j) neurological examinations.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  25/EE/0095

• Date of REC Opinion

  4 Aug 2025

• REC opinion

  Further Information Favourable Opinion