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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

For more information, please visit:

PrismPDstudy.com

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neuraly, Inc.

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