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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04893083
Other study ID # N23-PD-001
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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