Parkinson's Disease Inflammatory Biomarker Profiling | NCT03633513

Studies
Parkinson's Disease Inflammatory Biomarker Profiling

NCT03633513

Sponsor

Longevity Biotech

Status

Terminated

Last Update Posted

Apr 18, 2024Actual

Enrollment

99Actual

Phase

Not provided

Conditions

Parkinson Disease

Interventions

LBT-3627
Immunological profiling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

COVID-19

Expanded Access Info

Start Date

Jul 10, 2018Actual

Primary Completion Date

Mar 13, 2020Actual

Completion Date

Mar 13, 2020Actual

First Submitted Date

Jul 15, 2018

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2024

Last Update Posted Date

Apr 18, 2024Actual

Name	Class
Michael J. Fox Foundation for Parkinson's Research	OTHER
Corporal Michael J. Crescenz VA Medical Center - Philadelphia	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study compares a comprehensive panel of immunological biomarkers between Parkinson's disease patients and healthy, environmentally matched participants. This unique study design provides the ability to control for differences in environment between study subjects. The goal of this study is to 1) identify a specific set of immunological markers that correlate with a clinical diagnosis of Parkinson's disease and 2) stratify patients by disease severity using these same biomarkers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients		Clinical diagnosed Parkinson's disease patients	Diagnostic Test: LBT-3627 Diagnostic Test: Immunological profiling
Caregivers		Environmentally matched healthy control subjects	Diagnostic Test: LBT-3627 Diagnostic Test: Immunological profiling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LBT-3627	Diagnostic Test	Immunomodulatory agent	Caregivers Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Unified Parkinson Disease Rating Scale	Clinical scoring system to evaluate severity of Parkinson's disease in patients	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Interleukin-17	Proinflammatory cytokine	48 hours
FoxP3	Regulatory Tcell marker	48 hours

Other Outcomes

Measure	Description	Time Frame
Immune cell functional analysis	Performance evaluation of protective immune cells (Tregs) compared to responder immune cells (Tresp)	1 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria

All Participants

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

All Participants

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with Parkinson's disease and their caregivers.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Corporal Michael J. Crescenz VA Medical Center		Philadelphia	Pennsylvania	19104	United States
Longevity Biotech, Inc

ID	Term
D010300	Parkinson Disease
D000090862	Neuroinflammatory Diseases
D007249	Inflammation

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases