NCT04518059Completed
Misfolded Proteins in the Skin of People With Parkinson's Disease and Other Parkinsonism
Assessing Skin Biomarkers for Preclinical Diagnosis of PD and Non-PD Parkinsonism
Source: ClinicalTrials.gov · Last updated 1 Jul 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 184 (actual)
- First submitted
- 31 Jul 2020
- Start date
- 12 Mar 2019
- Primary completion date
- 31 May 2025
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Diseases
- Lewy body dementia, Parkinson disease
- NCT number
- NCT04518059
What you commit to
- Study type: Observational
- Participants enrolled: 184
- From 12 Mar 2019 to the primary completion date, 31 May 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of deep brain stimulation (DBS) or other brain surgery prior to Visit 1
- Use of investigational drugs or devices within 60 days prior to baseline visit (except for dietary supplements)
- 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)
Other illness
- Allergy to local anesthetic
- For PD or DLB, history of negative DATscan
- 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
- Any other medical, psychiatric, or cognitive illness that in the investigator's opinion would interfere with cooperation or ability to undergo the study procedures.
Age
- Age 90 or above
Other
- For PD or DLB diagnoses, any other neurodegenerative or central nervous system process that would interfere with examination
Who the study is looking for
- 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
Age in the registry: 21 years to 89 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| University Hospitals Suburban Health Center Coordinator of this site? Confirm its status | South Euclid | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.