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

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Brief Title

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

Official Title

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

Brief 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 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 Type

Observational [Patient Registry]


Primary Outcome

Amount of alpha-synuclein in the skin

Secondary Outcome

 Change in Montreal Cognitive Assessment (MoCA)

Condition

Parkinson Disease

Intervention

punch skin biopsy

Study Arms / Comparison Groups

 Parkinsonism Group
Description:  Participants with Parkinson's disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), and corticobasal degeneration (CBD)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

250

Start Date

March 12, 2019

Completion Date

May 31, 2024

Primary Completion Date

May 31, 2024

Eligibility 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.
      

Gender

All

Ages

21 Years - 89 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Steven Gunzler, MD, 216-844-1800, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04518059

Organization ID

20181189

Secondary IDs

1U01NS112010-01

Responsible Party

Principal Investigator

Study Sponsor

University Hospitals Cleveland Medical Center

Collaborators

 Case Western Reserve University

Study Sponsor

Steven Gunzler, MD, Principal Investigator, University Hospitals Cleveland Medical Center and Case Western Reserve University


Verification Date

April 2022