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

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ClinicalTrials.gov Identifier: NCT03359226
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Charles Adler, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: Submandibular gland biopsy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson&Apos;s Disease
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Submandibular gland biopsy
No treatment is being used in this study. Study participants will have bilateral submandibular gland biopsies.
 Procedure: Submandibular gland biopsy
Needle biopsies of the right and left submandibular glands


Outcome Measures
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Primary Outcome Measures :
  1. Presence of alpha-synuclein in the submandibular gland [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  1. PD patients ages up to age 85.
  2. Previous participation in a SMG biopsy study at Mayo Clinic Arizona with a positive biopsy being reported

Exclusion criteria

  1. Evidence for dementia that would preclude the patient from signing informed consent
  2. History of bleeding diathesis or hematologic disorders
  3. Medically unable to undergo a core needle biopsy of the submandibular gland
  4. Prior treatment of the submandibular gland with botulinum toxin injections.
  5. History of past or current acute infection or abscess of the submandibular gland.
  6. History of past or current neoplastic process within the submandibular gland.
  7. History of peripheral neuropathy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359226


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Charles H Adler Mayo Clinic
More Information
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Responsible Party: Charles Adler, Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03359226    
Other Study ID Numbers: 17-007240
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases