Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Procedure: Submandibular gland biopsy
- Registration Number
- NCT03359226
- Lead Sponsor
- Mayo Clinic
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Submandibular gland biopsy Submandibular gland biopsy No treatment is being used in this study. Study participants will have bilateral submandibular gland biopsies.
- Primary Outcome Measures
Name Time Method Presence of alpha-synuclein in the submandibular gland baseline 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic in Arizona
🇺🇸Scottsdale, Arizona, United States