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A Clinical Study of NLY01 in Patient’s With Early Parkinson’s Disease

Sponsor:

Information provided by (Responsible Party):

Neuraly, Inc.

Brief Summary:

This is a phase 2 study designed to assess the safety, tolerability and efficacy of NLY01 in subjects with early untreated Parkinson’s disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.

Criteria

Inclusion Criteria:
  • Patients who are diagnosed with Parkinson’s disease according to UK Parkinson’s Disease Society Brain Bank Clinical Diagnostic criteria or Movement Disorder Society Research Criteria
  • Patients with Parkinson’s disease according to protocol specified scale assessments
  • DaTscan consistent with diagnosis of Parkinson’s Disease
  • Men or women 30 to 80 years of age
Exclusion Criteria:
  • Diagnosis of secondary or atypical parkinsonism
  • Prior use of dopaminergic treatment or MAO-B inhibitors for more than 28 days
  • Medical or recreational use of marijuana or THC-containing compounds within 3 months of screening visit
  • Pregnant or planning to become pregnant
  • Metabolic, surgical, psychiatric or laboratory abnormality that would interfere with study compliance or safety in the judgment of the investigator

Locations

  • University of California, Irvine, California, United States, 92697
  • Keck School of Medicine of USC/University of Southern California, Los Angeles, California, United States, 90033
  • SC3 Research, Pasadena, California, United States, 91105
  • University of California, San Francisco, San Francisco, California, United States, 94143
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