Parkinson's DiseaseS4NCT02572713
Systemic Synuclein Sampling Study (S4)
An observational study of Parkinson's Disease, run by Michael J. Fox Foundation for Parkinson's Research at 6 sites in 2 countries.
Trial summary
The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids in Parkinson's disease (PD). This may help in developing better treatments for PD patients in the future. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Biofluid samplings, Tissue samplings and DaTSCAN™
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2015to 1 Aug 2017
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited through patient care clinics, physician referrals, and by reaching out to the community (e.g. PD-affiliated groups).
Who may be able to join
- Male or female age 40 or older at the time of PD diagnosis.
- Clinical diagnosis of PD based on bradykinesia plus one of the following: rest tremor or rigidity.
- DAT deficit at screening based on visual interpretation of DaTSCAN™ imaging.
- PD subjects will need to fall into one of the following stages:
- Early untreated PD not requiring dopamine replacement medication (anticholinergics, MAO-B inhibitors and amantadine permitted), Hoehn and Yahr 1-2, < 2 years from diagnosis.
- Moderate PD responsive and currently treated with dopamine replacement therapy without evidence of motor fluctuations or dyskinesias.
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- Advanced PD with motor fluctuations or dyskinesias, > 5 years from diagnosis.
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
- Willing and able to comply with scheduled visits, required study procedures and laboratory tests.
- Male or female age 50 or older at the time of the screening visit
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
- Willing and able to comply with scheduled visits, required study procedures and laboratory tests.
Who cannot join
- Has a history of cancer (other than basal and squamous cell skin cancers), autoimmune disorder, liver disease, or other hematological disorder within the past 5 years.
- Current treatment with anticoagulants (e.g., Coumadin, heparin) that would preclude safe completion of the lumbar puncture (LP) and tissue biopsy procedures.
- Current treatment with an antiplatelet agent (Plavix or aspirin >325 mg/day).
- Has a diagnosis of diabetes mellitus requiring either an oral agent or insulin therapy.
- A bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Has received botulinum toxin injections to the submandibular gland within the past year.
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- Has a condition that precludes safe performance of routine LP, such as prohibitive lumbar spinal disease.
- Has a condition that precludes the safe performance of the flexible sigmoidoscopy procedure or may interfere with obtaining evaluable colonic tissue biopsies, including a prior colonoscopy with significant findings (e.g. polyp with a positive finding, ulcerative colitis, Crohn's disease, inflammatory disease).
- Has a condition that precludes the safe performance of the submandibular gland procedure or may interfere with obtaining evaluable submandibular tissue biopsies, including any previous or active significant disease affecting the submandibular gland (e.g. inflammatory disease, infection, tumor).
- Has a condition that precludes the safe performance of the skin punch biopsy procedure or may interfere with obtaining evaluable skin tissue biopsies, including any previous or active significant dermatological disease (e.g. previous biopsy with any of the following findings: inflammatory disease, scar tissue, psoriasis, keloid formation, skin cancer).
- Any other medical or psychiatric condition or laboratory abnormality, which in the opinion of the Site Investigator would preclude participation.
- Use of investigational drugs or devices within 30 days prior to the screening visit.
- Has other significant neurological disorders (clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma, polyneuropathy).
- Has significant autonomic dysfunction (symptomatic orthostasis, hypotension or urinary incontinence) suggestive of an atypical parkinsonism.
- Has atypical features of parkinsonism including but not limited to supranuclear gaze palsy, early recurrent falls, corticospinal track abnormalities, cerebellar abnormalities, significant cognitive dysfunction.
- Has a family history of PD in any first-degree relative.
- Has a significant neurological disorder (a neurodegenerative condition, clinically significant stroke, brain tumor, hydrocephalus, epilepsy, other neurodegenerative disorders, encephalitis, repeated head trauma, polyneuropathy).
- Has a Montreal Cognitive Assessment (MoCA) score of less than 26.
- Has a diagnosis of REM sleep behavior disorder.
- Has a primary dystonia, restless legs syndrome, essential tremor, or other movement disorder.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
University of Pennsylvania
Philadelphia, Pennsylvania, 19107
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Canada1 site
Toronto Western Hospital Movement Disorders Centre
Toronto, Ontario, M5T 2S8
About this study
The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids in Parkinson's disease (PD). This may help in developing better treatments for PD patients in the future.
Read the detailed description
This is a multi-center, cross-sectional, observational study to evaluate α-syn pathology in multiple tissues and biofluids in individual subjects with PD and HC at a single time point.
- Conditions
- Parkinson's Disease
- Being tested
- Biofluid samplings, Tissue samplings, DaTSCAN™
- Keywords
- Parkinson's Disease, alpha-synuclein, biomarker
- Medical subject headings
- Parkinson Disease, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofluid samplingsProcedure or surgery
Biofluid samplings (blood, saliva, and cerebrospinal fluid (CSF)
Tissue samplingsProcedure or surgery
Tissue samplings (skin, colon, submandibular gland)
DaTSCAN™Drug
Also called ioflupane-123I
| Study group | Role | What they receive |
|---|---|---|
| Early PD | 20 early PD not requiring dopamine replacement therapy have been enrolled. Receives: Procedure: Biofluid samplings; Procedure: Tissue samplings; Drug: DaTSCAN™ | |
| Moderate PD | 20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled. Receives: Procedure: Biofluid samplings; Procedure: Tissue samplings; Drug: DaTSCAN™ | |
| Advanced PD | 21 advanced PD with motor fluctuations have been enrolled. Receives: Procedure: Biofluid samplings; Procedure: Tissue samplings; Drug: DaTSCAN™ | |
| Healthy Controls | 21 healthy controls have been enrolled. Receives: Procedure: Biofluid samplings; Procedure: Tissue samplings; Drug: DaTSCAN™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
α-syn levels in blood
Blood will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
Measured: 24 months
α-syn levels in saliva
Saliva will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
Measured: 24 months
α-syn levels in CSF
CSF will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
Measured: 24 months
α-syn deposits in skin
α-syn burden in skin biopsies will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
Measured: 24 months
α-syn deposits in submandibular gland
α-syn burden in the submandibular tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
Measured: 24 months
α-syn deposits in colon
α-syn burden in the colon tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, University of Iowa, Banner Health, Paracelsus Elena Klinik
- Responsible party
- Principal investigator, Lana Chahine, MD, University of Pennsylvania
- Investigators
- Lana Chahine, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572713
- Sponsor's protocol ID
- S4-001
- Acronym
- S4
- Status last verified
- Aug 2017
- First submitted
- 7 Oct 2015
- Last updated
- 17 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Synuclein Sampling Study (S4)
- ClinicalTrials.gov ID
- NCT02572713
- Acronym / sponsor ID
- S4 / S4-001
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, alpha-synuclein, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Michael J. Fox Foundation for Parkinson's ResearchUniversity, hospital or other
- Collaborators
- Indiana University, University of Iowa, Banner Health, Paracelsus Elena Klinik
- Study start
- Oct 2015
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 9 Oct 2015 (estimated)
- 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.
The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids in Parkinson's disease (PD). This may help in developing better treatments for PD patients in the future.
Detailed description
This is a multi-center, cross-sectional, observational study to evaluate α-syn pathology in multiple tissues and biofluids in individual subjects with PD and HC at a single time point.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early PD | – | Procedure: Biofluid samplings, Procedure: Tissue samplings, Drug: DaTSCAN™20 early PD not requiring dopamine replacement therapy have been enrolled. |
| Moderate PD | – | Procedure: Biofluid samplings, Procedure: Tissue samplings, Drug: DaTSCAN™20 moderate PD on dopamine replacement therapy without motor fluctuations have been enrolled. |
| Advanced PD | – | Procedure: Biofluid samplings, Procedure: Tissue samplings, Drug: DaTSCAN™21 advanced PD with motor fluctuations have been enrolled. |
| Healthy Controls | – | Procedure: Biofluid samplings, Procedure: Tissue samplings, Drug: DaTSCAN™21 healthy controls have been enrolled. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited through patient care clinics, physician referrals, and by reaching out to the community (e.g. PD-affiliated groups).
Key inclusion criteria (12 listed)
- Male or female age 40 or older at the time of PD diagnosis.
- Clinical diagnosis of PD based on bradykinesia plus one of the following: rest tremor or rigidity.
- DAT deficit at screening based on visual interpretation of DaTSCAN™ imaging.
- PD subjects will need to fall into one of the following stages:
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
Key exclusion criteria (20 listed)
- Has a history of cancer (other than basal and squamous cell skin cancers), autoimmune disorder, liver disease, or other hematological disorder within the past 5 years.
- Current treatment with anticoagulants (e.g., Coumadin, heparin) that would preclude safe completion of the lumbar puncture (LP) and tissue biopsy procedures.
- Current treatment with an antiplatelet agent (Plavix or aspirin >325 mg/day).
- Has a diagnosis of diabetes mellitus requiring either an oral agent or insulin therapy.
- A bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
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 |
|---|---|---|
| Biofluid samplingsBiofluid samplings (blood, saliva, and cerebrospinal fluid (CSF) | Procedure or surgery | Advanced PD, Early PD, Healthy Controls, Moderate PD |
| Tissue samplingsTissue samplings (skin, colon, submandibular gland) | Procedure or surgery | Advanced PD, Early PD, Healthy Controls, Moderate PD |
| DaTSCAN™Also: ioflupane-123I | Drug | Advanced PD, Early PD, Healthy Controls, Moderate PD |
Primary outcome
α-syn levels in blood
Time frame: 24 months
Blood will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn levels in saliva
Time frame: 24 months
Saliva will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn levels in CSF
Time frame: 24 months
CSF will be analyzed using the most optimal, currently available, quantitative assays. The outcome will be expressed as a concentration of α-syn levels.
α-syn deposits in skin
Time frame: 24 months
α-syn burden in skin biopsies will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
α-syn deposits in submandibular gland
Time frame: 24 months
α-syn burden in the submandibular tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
α-syn deposits in colon
Time frame: 24 months
α-syn burden in the colon tissue will be expressed as 1) simply positive or negative, i.e. whether any two slides are positive out of all examined 2) by total percentage of slides examined that are positive 3) by site of highest density of positive α-syn fibers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
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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.
Lana Chahine, MD principal investigator
University of Pennsylvania
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Michael J. Fox Foundation for Parkinson's Research at 6 sites in 2 countries.
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 12 inclusion and 20 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: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
α-syn levels in blood (time frame: 24 months). The study lists 6 primary outcomes in all. 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 17 Aug 2017.