COMPLETED

Misfolded Proteins in the Skin of People With Parkinson's Disease and Other Parkinsonism

Conditions

Parkinson Disease Parkinsonism Dementia With Lewy Bodies Multiple System Atrophy Progressive Supranuclear Palsy Corticobasal Degeneration Parkinson's disease biomarker alpha-synuclein

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Assessing Skin Biomarkers for Preclinical Diagnosis of PD and Non-PD Parkinsonism

Quick Facts

Study Start:2019-03-12

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04518059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Principal Investigator

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

Qingzhong Kong, PhD

PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Study Locations (Sites)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

University Hospitals Suburban Health Center

South Euclid, Ohio, 44121

United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

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
Qingzhong Kong, PhD, PRINCIPAL_INVESTIGATOR, Case Western Reserve University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-12

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2019-03-12

Study Completion Date2025-05-31

Terms related to this study

Keywords Provided by Researchers

Parkinson disease
Parkinson's disease
dementia with Lewy bodies
multiple system atrophy
progressive supranuclear palsy
corticobasal degeneration
biomarker
parkinsonism
alpha-synuclein

Additional Relevant MeSH Terms

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