This study is in progress, not accepting new patients

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

a study on Parkinson's Disease

Summary

Eligibility
for people ages 30-80 (full criteria)
Location
at UC Davis UC Irvine UCLA UCSF
Dates
study started
completion around
Principal Investigator
by Yvette Bordelon (ucla)

Description

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.

Official Title

Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's Disease

Keywords

Parkinson Disease, NLY01, Vehicle, NLY01 (2.5 mg), NLY01 (5.0 mg)

Eligibility

You can join if…

Open to people ages 30-80

  • 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

You CAN'T join if...

  • 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
    Irvine California 92697 United States
  • University of California, Los Angeles, Center for Neurotherapeutics
    Los Angeles California 90095 United States
  • University of California Davis Health
    Sacramento California 95816 United States
  • University of California, San Francisco
    San Francisco California 94143 United States
  • Keck School of Medicine of USC/University of Southern California
    Los Angeles California 90033 United States
  • SC3 Research
    Pasadena California 91105 United States

Lead Scientist at University of California Health

  • Yvette Bordelon (ucla)
    Professor of Clinical, Neurology, Medicine. Authored (or co-authored) 84 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neuraly, Inc.
ID
NCT04154072
Phase
Phase 2 Parkinson's Disease Research Study
Study Type
Interventional
Participants
About 255 people participating
Last Updated