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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04893083
• Other study ID #: N23-PD-001
• Status: Terminated
• Start date: June 28, 2021
• Est. completion date: September 22, 2023

Study information

• Verified date: October 2023
• Source: Neuron23 Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: September 22, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Canada	McGill University	Montréal
Canada	Universite Laval	Québec City	Quebec
France	Assistance Publique - Hospitaux de Paris	Paris
Israel	Sheba Tel HaShomer	Ramat Gan
Israel	Tel Aviv Medical Center	Tel Aviv
United States	Rocky Mountain Movement Disorders Center	Englewood	Colorado
United States	Quest Research Institute	Farmington Hills	Michigan
United States	Evergreen Health	Kirkland	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Neuron23 Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic Marker	Test for LRRK2 mutations in Parkinson disease patients; identifying patients with potential genetic modifiers	1 day