Clinical trial NCT04893083: A Non-interventional Study for the Collection of Biospecimens From Patients With Parkinson's Disease
Official title: A Multi-center, Non-interventional Phase 0 Study for the Collection of Biospecimens From Patients With Parkinson's Disease.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson Disease
Lead sponsor: Neuron23 Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 65
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's patients will be recruited across this multi-center, global clinical study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Genetic Marker
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Rocky Mountain Movement Disorders Center
state: Colorado
city: Farmington Hills
country: United States
facility: Quest Research Institute
state: Michigan
city: Kirkland
country: United States
facility: Evergreen Health
state: Washington
city: Québec City
country: Canada
facility: Universite Laval
state: Quebec
city: Montréal
country: Canada
facility: McGill University
city: Paris
country: France
facility: Assistance Publique - Hospitaux de Paris
city: Ramat Gan
country: Israel
facility: Sheba Tel HaShomer
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References: