Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
99 participants
OBSERVATIONAL
2018-07-10
2020-03-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients
Clinical diagnosed Parkinson's disease patients
LBT-3627
Immunomodulatory agent
Immunological profiling
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays
Caregivers
Environmentally matched healthy control subjects
LBT-3627
Immunomodulatory agent
Immunological profiling
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays
Interventions
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LBT-3627
Immunomodulatory agent
Immunological profiling
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays
Eligibility Criteria
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Inclusion Criteria
* Subjects must be willing and able to participate in study
* Subjects must be willing and able to provide written consent to participate.
* Subjects must be willing and able to comply with scheduled clinic visits and study procedures (UPDRS exam, blood draw and complete a questionnaire)
* Subjects are not currently taking an immunomodulatory (e.g. anti- tumor necrosis factor (TNF), immunosuppressants/stimulants) agent in the past 90 days
* No active or recent (\< 3 weeks) infection requiring clinical intervention and/or pharmaceutical treatment or febrile neutropenia within the last week.
* 18-89 years old
Parkinson's Disease Patients
* Clinical diagnosis of PD by a movement disorders specialist consistent with standard criteria
* Able to attend a clinical visit in the 'off' state
* Hoehn and Yahr stage I-IV
Caregiver Controls
• Individuals without PD who share environmental exposures (i.e. spouses, children, caregivers or other individuals who frequently spend significant time (\>6 hours) in proximity to the PD subject) OR age and sex matched healthy individuals from general population
Exclusion Criteria
* Unstable cardiopulmonary or cerebrovascular disease
* Renal disease or failure w/ serum creatinine greater than 2.5
* Severe or unstable depression or other axis I psychopathology
* Epilepsy
* Prior brain surgery related to PD (DBS, cell implantation, gene therapy, etc.)
* Severe head injury with evidence of brain injury
* Essential Thrombocythemia (ET) (\>450,000 platelets/mL)
* Patients currently being treated with any of the following, within the past 5 days:
* Immunomodulatory agents (e.g. Remicade®, Humira®, Enbrel®) (within the past 90 days)
* Corticosteroids
* Probenecid®
* Coenzyme Q10®
* Anticoagulants
18 Years
89 Years
ALL
Yes
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
Corporal Michael J. Crescenz VA Medical Center - Philadelphia
UNKNOWN
Longevity Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Shandler, PhD
Role: PRINCIPAL_INVESTIGATOR
Longevity Biotech, Inc
Locations
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Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, United States
Longevity Biotech, Inc
Philadelphia, Pennsylvania, United States
Countries
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Related Links
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Michael J. Fox Trial Finder
Other Identifiers
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LBT-PD-003
Identifier Type: -
Identifier Source: org_study_id
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