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

NCT04893083 | Terminated

• 1 other identifier: N23-PD-001
• Study Type: observational
• Target: 65
• Locations: 4 countries
• Sites: 8

Brief Summary

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Genetic Marker

  Test for LRRK2 mutations in Parkinson disease patients; identifying patients with potential genetic modifiers

  1 day

Study Arms (3)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuron23 Inc.: lead

Study Sites (8)

Rocky Mountain Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Evergreen Health

Kirkland, Washington, 98034, United States

Location

Universite Laval

Québec, Quebec, Canada

Location

McGill University

Montreal, Canada

Location

Assistance Publique - Hospitaux de Paris

Paris, France

Location

Sheba Tel HaShomer

Ramat Gan, Israel

Location

Tel Aviv Medical Center

Tel Aviv, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine, CSF

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 19, 2021
• Study Start: June 28, 2021
• Primary Completion: June 30, 2023
• Study Completion: September 22, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); US (3); CA (2); IL (2)