Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this study is to perform biopsies of one of the glands that make saliva. The biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's disease. This study will determine whether it is possible to do a second biopsy a few years after a previous biopsy and determine whether there are changes in the biopsy that would allow for analysis of disease progression.

Detailed Description
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Tissue biopsies documenting the presence and density of Lewy type synucleinopathy (LTS) in living patients with probable Parkinsons disease (PD) would be extremely valuable as a diagnostic test, as a marker of molecular therapeutic target engagement and as a progression marker. Based on recent data from our group with both early and advanced PD patients, we propose to perform a second transcutaneous submandibular gland (SMG) needle core biopsy in 12 patients who have previously been biopsied and had LTS present in their SMG tissue.

Official Title
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Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson&Apos;s Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Submandibular gland biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria PD patients ages up to age 85. Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported Exclusion criteria Evidence for dementia that would preclude the patient from signing informed consent History of bleeding diathesis or hematologic disorders Medically unable to undergo a core needle biopsy of the submandibular gland Prior treatment of the submandibular gland with botulinum toxin injections. History of past or current acute infection or abscess of the submandibular gland. History of past or current neoplastic process within the submandibular gland. History of peripheral neuropathy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Submandibular gland biopsy<br>No treatment is being used in this study. Study participants will have bilateral submandibular gland biopsies. | Procedure: Submandibular gland biopsy<br>* Needle biopsies of the right and left submandibular glands<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of alpha-synuclein in the submandibular gland | The biopsied submandibular gland tissue will be stained with an antibody for alpha-synuclein. The pathologist will review the slides and determine the number that show positive staining for neuronal elements. He will compare the number of positive slides between the right and left submandibular glands to see if they are similar. | baseline |