A Clinical Study of NLY01 in Patient’s With Early Parkinson’s Disease
Sponsor:
Neuraly, Inc.
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