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