A Non-interventional Study for the Collection of Biospecimens From Patients With Parkinson's Disease

A Multi-center, Non-interventional Phase 0 Study for the Collection of Biospecimens From Patients With Parkinson's Disease.

This study aims to collect, analyze and preserve biospecimens from patients with or without LRRK2-associated Parkinson's Disease for the purpose of discovering and developing new treatments and novel biomarkers.

Study Overview

• Status: Terminated
• Conditions: Parkinson Disease

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Canada
  • Montréal, Canada
    • McGill University
  • Quebec
    • Québec City, Quebec, Canada
      • Université Laval
• France
  • Paris, France
    • Assistance Publique - Hospitaux de Paris
• Israel
  • Ramat Gan, Israel
    • Sheba Tel Hashomer
  • Tel Aviv, Israel
    • Tel Aviv Medical Center
• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • Rocky Mountain Movement Disorders Center
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Quest Research Institute
  • Washington
    • Kirkland, Washington, United States, 98034
      • Evergreen Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Parkinson's patients will be recruited across this multi-center, global clinical study.

Description

Inclusion Criteria:

• Male or female ≥40
• Clinical diagnosis of Parkinson's disease meeting United Kingdom Brain Bank criteria and modified Hoehn and Yahr Stage I, II, or III;
• Willing to undergo genetic testing for neurologic genotyping panel; -If being treated for Parkinson's disease, must have been on a stable dose of anti- Parkinson's disease medications for a minimum of 30 days prior to Day 1;
• If taking statins, fibrates, antipsychotic or anticonvulsant medications at Day 1, must have been on a stable dose for a minimum of 30 days, and are not likely to require a change in dosage for the remainder of the study;

Exclusion Criteria:

• Any major medical illness or unstable medical condition within 6 months of screening that, in the opinion of the Investigator or Sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions.
• Diagnosis of a significant central nervous system disease other than Parkinson's disease(eg, Huntington's disease, frontotemporal dementia, multi-infarct dementia, normal pressure hydrocephalus, multiple system atrophy, progressive supranuclear palsy, drug- induced parkinsonism, Alzheimer's disease)
• History of stroke;
• History of epilepsy or seizure disorder other than febrile seizures as a child, or any seizure or unexpected loss of consciousness (eg, syncope) within 6 months prior to Day 1;
• History of traumatic brain injury with residual neurological deficit; -If taking anti-Parkinson's disease medication(s)and are likely to require a change in anti- Parkinson's disease medication(s) during the study;
• Known active infectious disease or active infections within 30 days prior to Day 1;
• Any vaccination within 21 days prior to Day 1;
• Currently taking, or planning to take, anti-coagulant medications or antiplatelet medications during the study;
• Allergy to Lidocaine (xylocaine) or its derivatives or any other LP contraindications;
• Any other condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject's risk by participating in the study; -Any systemic glucocorticoids taken within 14 days prior to Day 1 or non-steroidal anti- inflammatory drugs taken within 4 days prior to Day 1;
• Received blood products within 30 days prior to Day 1;
• Donated blood within 30 days prior to Day 1.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
LRRK2 Mutant PD; Patients with a G2019S mutation
LRRK2 Wild Type PD Low burden; Patients with a low burden of genetic modifiers
LRRK2 Wild Type High burden; Patients with a high burden of genetic modifiers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic Marker	Test for LRRK2 mutations in Parkinson disease patients; identifying patients with potential genetic modifiers	1 day

Collaborators and Investigators

• Sponsor: Neuron23 Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): September 22, 2023

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 18, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: N23-PD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No