NCT04518059

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 184 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Parkinson Disease
• Parkinsonism
• Dementia With Lewy Bodies
• Multiple System Atrophy
• Progressive Supranuclear Palsy
• Corticobasal Degeneration

Interventions

Type	Name	Description
PROCEDURE	punch skin biopsy	An anesthetic medication is injected to numb the areas of skin and two samples of skin are obtained from punch biopsy.

Timeline

• Start date: 2019-03-12
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2020-08-19
• Last updated: 2025-07-01

Locations

2 sites across 1 country: United States