Identifying misfolded proteins in the skin of people with Parkinson's disease and related conditions
Assessing Skin Biomarkers for Preclinical Diagnosis of PD and Non-PD Parkinsonism
This study is trying to see if looking for misfolded proteins in skin samples can help doctors tell the difference between Parkinson's disease and similar conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 21 Years to 89 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center Academic / other |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT04518059 on ClinicalTrials.gov |
What this trial studies
This observational study aims to determine if identifying misfolded proteins in skin samples can help differentiate between various types of parkinsonism, such as Parkinson's disease, multiple system atrophy, and dementia with Lewy bodies, versus tauopathies like progressive supranuclear palsy. Participants will undergo skin punch biopsies, along with physical examinations, cognitive assessments, and other tests over a period of 1 to 2 years. The goal is to improve diagnostic accuracy for these conditions, which can be challenging to distinguish in early stages. The study will also include healthy volunteers as controls.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 21 to 90 with a confirmed diagnosis of Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, progressive supranuclear palsy, or healthy controls.
Not a fit: Patients over 90 years old or those with a history of deep brain stimulation or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of parkinsonism, allowing for better-targeted treatments.
How similar studies have performed: This approach is novel and has not been extensively tested in previous studies, making it a potentially groundbreaking investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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.
Where this trial is running
Cleveland, Ohio and 1 other locations
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- University Hospitals Suburban Health Center — South Euclid, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Steven Gunzler, MD — University Hospitals Cleveland Medical Center and Case Western Reserve University
- Study coordinator: Kailey Sajewski
- Email: Kailey.Sajewski@UHhospitals.org
- Phone: 216-286-6597
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.