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

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    250
  • sponsor
    University Hospitals Cleveland Medical Center
Updated on 23 April 2022
dementia
atrophy
parkinson's disease
parkinsonism
cognitive assessment
progressive supranuclear palsy
tauopathies
lewy body dementia
synucleinopathy
supranuclear palsy
corticobasal degeneration
Accepts healthy volunteers

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).

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.

Details
Condition Parkinson Disease, Parkinsonism, Dementia With Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration
Treatment Punch skin biopsy
Clinical Study IdentifierNCT04518059
SponsorUniversity Hospitals Cleveland Medical Center
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

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
Any other medical, psychiatric, or cognitive illness that in the investigator's opinion would interfere with cooperation or ability to undergo the study procedures
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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note