Parkinson DiseaseNCT04518059
Misfolded Proteins in the Skin of People With Parkinson's Disease and Other Parkinsonism
An observational study of Parkinson Disease and Parkinsonism, run by University Hospitals Cleveland Medical Center at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether identification of misfolded proteins in the skin will help to determine what sort of parkinsonism someone has. We seek to demonstrate whether someone has a synucleinopathy such as Parkinson's disease (PD), multiple system atrophy (MSA), or dementia with Lewy… Read more about this study
- Who is it for?
- Ages 21 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinsonism, Dementia With Lewy Bodies
- What is being tested?
- punch skin biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 184 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2019to 31 May 2025
- How long will I take part?
- 2 Years
- 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 21 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with parkinsonism, Parkinson's disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD), and also controls without parkinsonism.
Who may be able to join
- Age 21 years old and age <90 years of age at the time of the baseline visit 1
- Age of diagnosis at least 40 years old for PD, DLB, and PSP and at least 30 years old for MSA
- A confirmed diagnosis of PD, PSP, CBD, MSA, DLB, or healthy control
- Montreal Cognitive Assessment (MoCA) > 10 at the outset of the study
Who cannot join
- Age 90 or above
- Allergy to local anesthetic
- History of deep brain stimulation (DBS) or other brain surgery prior to Visit 1
- For PD or DLB diagnoses, any other neurodegenerative or central nervous system process that would interfere with examination
- For PD or DLB, history of negative DATscan
- Use of investigational drugs or devices within 60 days prior to baseline visit (except for dietary supplements)
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- In control subjects, family history of a neurodegenerative disease in a first degree or second degree blood relative
- History of schizophrenia
- History of antipsychotic medication use or exposure in controls or history of antipsychotic medication leading to parkinsonism (drug induced parkinsonism) in the parkinsonism group
- Blood clotting disorder
- On multiple (more than one) antiplatelet and/or anticoagulant blood thinner medications in combination (except for aspirin if it can be safely held for 1 week)
- Any other medical, psychiatric, or cognitive illness that in the investigator's opinion would interfere with cooperation or ability to undergo the study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University Hospitals Suburban Health Center
South Euclid, Ohio, 44121
About this study
Official title: Assessing Skin Biomarkers for Preclinical Diagnosis of PD and Non-PD Parkinsonism
The purpose of this study is to determine whether identification of misfolded proteins in the skin will help to determine what sort of parkinsonism someone has. We seek to demonstrate whether someone has a synucleinopathy such as Parkinson's disease (PD), multiple system atrophy (MSA), or dementia with Lewy bodies(DLB), as opposed to a tauopathy such as progressive supranuclear palsy (PSP) or corticobasal degeneration (CBD) or no parkinsonism at all (control).
Read the detailed description
This is a clinical research study for patients with parkinsonism, including Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, and dementia with Lewy bodies. Parkinsonism can be difficult to diagnose, especially in the early stages of the disease. Skin punch biopsy could be a useful and way to diagnose and measure the severity of these conditions. Given that there currently is no proven way to determine that someone has a synucleinopathy such as PD and not a tauopathy, this is a novel study that may lead to better ways to diagnose people with parkinsonism. The purpose of the study is to identify changes on a skin punch biopsy, in which small samples of skin are removed and sent to the laboratory for examination. We are seeking to measure the amount of misfolded alpha-synuclein in someone's skin. Participation will last between 1 and 2 years and will involve between 2 and 4 visits. Visits will include a physical examination, questionnaires, a memory test, blood draws and saliva collection, and a single visit for skin punch biopsies. We will also be looking to enroll volunteers to serve as "controls," who do not have any neurological illness.
- Conditions
- Parkinson Disease, Parkinsonism, Dementia With Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration
- Being tested
- punch skin biopsy
- Keywords
- Parkinson disease, Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, biomarker, parkinsonism, alpha-synuclein
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Lewy Body Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive, Corticobasal Degeneration, 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.
punch skin biopsyProcedure or surgery
An anesthetic medication is injected to numb the areas of skin and two samples of skin are obtained from punch biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Parkinsonism Group | Participants with Parkinson's disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD) Receives: Procedure: punch skin biopsy | |
| Control Group | Participants without parkinsonism Receives: Procedure: punch skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of alpha-synuclein in the skin
Alpha-synuclein will be measured by RT-QuIC and sPMCA
Measured: Cross-sectional at baseline
Change in PSPRS measures of progressive supranuclear palsy (PSP) severity in people with PSP
Questionnaire and examination. Lower scores are better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in UMSARS measures of multiple system atrophy (MSA) severity in people with MSA
Questionnaire and examination. Lower scores are better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in Hoehn and Yahr (H&Y) and modified H&Y Scores
Zero to 5 parkinsonism rating scale score. Lower score is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in Schwab and England (S&E) Score
0% to 100% rating scale score. Higher score is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Secondary outcomes (8)
Change in Montreal Cognitive Assessment (MoCA)
Zero to 30 cognitive rating scale score. Higher score is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in Epworth Sleepiness Scale (ESS)
Zero to 24 sleepiness rating scale score. Lower score is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in Hamilton depression scale
17 item depression rating scale score. Lower score is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in Hamilton anxiety scale
14 item depression rating scale score. Lower score is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in REM Behavior Disorder Questionnaire
10 item depression rating scale score. Lower score is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Change in blood pressure with orthostatic posture
Blood pressure from lying down to sitting to standing. Smaller drop in blood pressure is better.
Measured: Baseline, 1 year, and optional 2 year assessment
Amount of alpha-synuclein in the blood
Alpha-synuclein will be measured in the blood sample
Measured: Baseline, optional 1 year assessment, and optional 2 year assessment
Change in PDQ-39
39 item health status questionnaire. Lower is better.
Measured: Baseline, optional 1 year assessment, and optional 2 year assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start12 Mar 2019
- Primary completion31 May 2025
- Study completion31 May 2025
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.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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
- 184 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Case Western Reserve University, National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Allergy and Infectious Diseases (NIAID), Banner Health, University of Bologna, Universidad Autonoma de San Luis Potosí
- Responsible party
- Principal investigator, Steven Gunzler, MD, University Hospitals Cleveland Medical Center
- Investigators
- Steven Gunzler, MD, Principal investigator, University Hospitals Cleveland Medical Center and Case Western Reserve UniversityChen Shu, PhD, Principal investigator, University of Alabama at BirminghamZerui Wang, MD, PhD, Principal investigator, Case Western Reserve UniversityQingzhong Kong, PhD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518059
- Sponsor's protocol ID
- 20181189
- Other IDs
- 1U01NS112010-01
- Status last verified
- Jun 2025
- First submitted
- 31 Jul 2020
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Skin Biomarkers for Preclinical Diagnosis of PD and Non-PD Parkinsonism
- ClinicalTrials.gov ID
- NCT04518059
- Acronym / sponsor ID
- 20181189
- Conditions
- Parkinson Disease, Parkinsonism, Dementia With Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration
- Keywords
- Parkinson disease, Parkinson's disease, dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, biomarker, parkinsonism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Case Western Reserve University, National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Allergy and Infectious Diseases (NIAID), Banner Health, University of Bologna, Universidad Autonoma de San Luis Potosí
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 19 Aug 2020 (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.
The purpose of this study is to determine whether identification of misfolded proteins in the skin will help to determine what sort of parkinsonism someone has. We seek to demonstrate whether someone has a synucleinopathy such as Parkinson's disease (PD), multiple system atrophy (MSA), or dementia with Lewy bodies(DLB), as opposed to a tauopathy such as progressive supranuclear palsy (PSP) or corticobasal degeneration (CBD) or no parkinsonism at all (control).
Detailed description
This is a clinical research study for patients with parkinsonism, including Parkinson's disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, and dementia with Lewy bodies. Parkinsonism can be difficult to diagnose, especially in the early stages of the disease. Skin punch biopsy could be a useful and way to diagnose and measure the severity of these conditions. Given that there currently is no proven way to determine that someone has a synucleinopathy such as PD and not a tauopathy, this is a novel study that may lead to better ways to diagnose people with parkinsonism. The purpose of the study is to identify changes on a skin punch biopsy, in which small samples of skin are removed and sent to the laboratory for examination. We are seeking to measure the amount of misfolded alpha-synuclein in someone's skin. Participation will last between 1 and 2 years and will involve between 2 and 4 visits. Visits will include a physical examination, questionnaires, a memory test, blood draws and saliva collection, and a single visit for skin punch biopsies. We will also be looking to enroll volunteers to serve as "controls," who do not have any neurological illness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinsonism Group | – | Procedure: punch skin biopsyParticipants with Parkinson's disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD) |
| Control Group | – | Procedure: punch skin biopsyParticipants without parkinsonism |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with parkinsonism, Parkinson's disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD), and also controls without parkinsonism.
Key inclusion criteria (4 listed)
- Age 21 years old and age <90 years of age at the time of the baseline visit 1
- Age of diagnosis at least 40 years old for PD, DLB, and PSP and at least 30 years old for MSA
- A confirmed diagnosis of PD, PSP, CBD, MSA, DLB, or healthy control
- Montreal Cognitive Assessment (MoCA) > 10 at the outset of the study
Key exclusion criteria (12 listed)
- Age 90 or above
- Allergy to local anesthetic
- History of deep brain stimulation (DBS) or other brain surgery prior to Visit 1
- For PD or DLB diagnoses, any other neurodegenerative or central nervous system process that would interfere with examination
- For PD or DLB, history of negative DATscan
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 |
|---|---|---|
| punch skin biopsyAn anesthetic medication is injected to numb the areas of skin and two samples of skin are obtained from punch biopsy. | Procedure or surgery | Control Group, Parkinsonism Group |
Primary outcome
Amount of alpha-synuclein in the skin
Time frame: Cross-sectional at baseline
Alpha-synuclein will be measured by RT-QuIC and sPMCA
Change in PSPRS measures of progressive supranuclear palsy (PSP) severity in people with PSP
Time frame: Baseline, 1 year, and optional 2 year assessment
Questionnaire and examination. Lower scores are better.
Change in UMSARS measures of multiple system atrophy (MSA) severity in people with MSA
Time frame: Baseline, 1 year, and optional 2 year assessment
Questionnaire and examination. Lower scores are better.
Change in Hoehn and Yahr (H&Y) and modified H&Y Scores
Time frame: Baseline, 1 year, and optional 2 year assessment
Zero to 5 parkinsonism rating scale score. Lower score is better.
Change in Schwab and England (S&E) Score
Time frame: Baseline, 1 year, and optional 2 year assessment
0% to 100% rating scale score. Higher score is better.
8 secondary outcomes
Change in Montreal Cognitive Assessment (MoCA)
Time frame: Baseline, 1 year, and optional 2 year assessment
Change in Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 1 year, and optional 2 year assessment
Change in Hamilton depression scale
Time frame: Baseline, 1 year, and optional 2 year assessment
Change in Hamilton anxiety scale
Time frame: Baseline, 1 year, and optional 2 year assessment
Change in REM Behavior Disorder Questionnaire
Time frame: Baseline, 1 year, and optional 2 year assessment
Change in blood pressure with orthostatic posture
Time frame: Baseline, 1 year, and optional 2 year assessment
Amount of alpha-synuclein in the blood
Time frame: Baseline, optional 1 year assessment, and optional 2 year assessment
Change in PDQ-39
Time frame: Baseline, optional 1 year assessment, and optional 2 year assessment
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 1 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Steven Gunzler, MD principal investigator
University Hospitals Cleveland Medical Center and Case Western Reserve University
Chen Shu, PhD principal investigator
University of Alabama at Birmingham
Zerui Wang, MD, PhD principal investigator
Case Western Reserve University
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 and Parkinsonism, run by University Hospitals Cleveland Medical Center 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 4 inclusion and 12 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 1 Jul 2025. 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 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?
Amount of alpha-synuclein in the skin (time frame: Cross-sectional at baseline). The study lists 5 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 1 Jul 2025.