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Blinded Comparison of Different Alpha-Synuclein Seeding Assays as Cutaneous Biomarkers of Lewy Body Dementias

Overview

About this study

The purpose of this study is twofold:

Specific Aim 1

  • In biopsies of skin from living subjects with DLB, PD without dementia (PD), and PD with dementia (PDD), assess the relative diagnostic sensitivity and specificity of IHC and seeding assay measures of aSyn, relative to normal control subjects.

Specific Aim 2

  • In second biopsies of skin from subjects with DLB, PD and PDD, assess whether IHC and seeding measures of aSyn progress, regress or remain stable over time, indicating whether these may be useful as measures of therapeutic agent target engagement and disease progression.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Males or females ≥ 40 years of age.
  • Willingness to undergo the required clinical assessments and biopsies.
  • Clinical diagnoses as DLB, PD and PDD.

Exclusion Criteria:

  • Are being treated with chemotherapy for cancer.
  • Are known to have a structural brain lesion or other CNS disease process or symptoms.
  • Have a clinically significant infectious disease, such as HIV, hepatitis or prion disease.
  • Have suspected encephalopathy due to alcoholism or end-stage liver disease.
  • Have a bleeding diathesis, are on anticoagulant therapy, or have severe medical illness.
  • Have skin disease in the posterior cervical area.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Bradley Boeve, M.D.

Open for enrollment

Contact information:

Elizabeth Abrahamson

(507) 422-9792

Abrahamson.Elizabeth@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Neill Graff Radford, M.D.

Open for enrollment

Contact information:

Amanda Phillips

Phillips.Amanda2@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Charles Adler, M.D., Ph.D.

Open for enrollment

Contact information:

Jennifer Hill

(480) 301-4720

Hill.Jennifer4@mayo.edu

More information

Publications

Publications are currently not available

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CLS-20530948

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