Parkinson DiseaseNCT03633513
Parkinson's Disease Inflammatory Biomarker Profiling
An observational study of Parkinson Disease, run by Longevity Biotech at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- LBT-3627 and Immunological profiling
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2018to 13 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients diagnosed with Parkinson's disease and their caregivers.
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
Longevity Biotech, Inc
Philadelphia, Pennsylvania, 19104
About this study
Official title: Inflammatory Parkinson's Disease (PD) Clinical Biomarker Profiling in T Cells
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.
- Conditions
- Parkinson Disease
- Being tested
- LBT-3627, Immunological profiling
- Keywords
- Immune System, Immunology, Neuroinflammation, Inflammation, Neuroprotection
- Medical subject headings
- Parkinson Disease, Neuroinflammatory Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBT-3627Diagnostic test
Immunomodulatory agent
Immunological profilingDiagnostic test
Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays
| Study group | Role | What they receive |
|---|---|---|
| Patients | Clinical diagnosed Parkinson's disease patients Receives: Diagnostic Test: LBT-3627; Diagnostic Test: Immunological profiling | |
| Caregivers | Environmentally matched healthy control subjects Receives: Diagnostic Test: LBT-3627; Diagnostic Test: Immunological profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson Disease Rating Scale
Clinical scoring system to evaluate severity of Parkinson's disease in patients
Measured: 1 hour
Secondary outcomes (7)
Interleukin-17
Proinflammatory cytokine
Measured: 48 hours
FoxP3
Regulatory Tcell marker
Measured: 48 hours
GM-CSF
Cytokine
Measured: 48 hours
LRRK2
Leucine rich region kinase 2 protein
Measured: 48 hours
VPAC2
Regulates TH1/TH2 balance of inflammatory system
Measured: 48 hours
Interferon gamma
Inflammatory cytokine
Measured: 48 hours
Tumor necrosis factor alpha
Inflammatory cytokine
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start10 Jul 2018
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Longevity Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Corporal Michael J. Crescenz VA Medical Center - Philadelphia
- Responsible party
- Sponsor
- Investigators
- Scott Shandler, PhD, Principal investigator, Longevity Biotech, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633513
- Sponsor's protocol ID
- LBT-PD-003
- Status last verified
- Apr 2024
- First submitted
- 15 Jul 2018
- Last updated
- 18 Apr 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Parkinson's Disease (PD) Clinical Biomarker Profiling in T Cells
- ClinicalTrials.gov ID
- NCT03633513
- Acronym / sponsor ID
- LBT-PD-003
- Conditions
- Parkinson Disease
- Keywords
- Immune System, Immunology, Neuroinflammation, Inflammation, Neuroprotection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Longevity BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Corporal Michael J. Crescenz VA Medical Center - Philadelphia
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: LBT-3627, Diagnostic Test: Immunological profilingClinical diagnosed Parkinson's disease patients |
| Caregivers | – | Diagnostic Test: LBT-3627, Diagnostic Test: Immunological profilingEnvironmentally matched healthy control subjects |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Parkinson's disease and their caregivers.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBT-3627Immunomodulatory agent | Diagnostic test | Caregivers, Patients |
| Immunological profilingComprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays | Diagnostic test | Caregivers, Patients |
Primary outcome
Unified Parkinson Disease Rating Scale
Time frame: 1 hour
Clinical scoring system to evaluate severity of Parkinson's disease in patients
7 secondary outcomes
Interleukin-17
Time frame: 48 hours
FoxP3
Time frame: 48 hours
GM-CSF
Time frame: 48 hours
LRRK2
Time frame: 48 hours
VPAC2
Time frame: 48 hours
Interferon gamma
Time frame: 48 hours
Tumor necrosis factor alpha
Time frame: 48 hours
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Michael J. Fox Trial FinderLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Shandler, PhD principal investigator
Longevity Biotech, Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Longevity Biotech at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson Disease Rating Scale (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.