Submandibular Gland Needle Core Biopsy and Skin Punch Biopsy as Tissue Biomarkers for the Diagnosis and Monitoring of Disease Progression of Parkinson’s Disease and REM Sleep Behavior Disorder


About this study

Determine 1) the magnitude of SMG and skin a-syn density change over time, 2) the

improvement in adequate tissue acquisition doing bilateral SMG biopsies, 3) any laterality differences between

SMG gland a-syn density, 4) correlate a-syn density and changes in density between SMG and skin biopsies

Specific Aim 1. Determine, with bilateral submandibular gland (SMG) biopsies in 30 clinically

diagnosed subjects with Parkinson’s disease (PD) and 20 clinically probable REM sleep behavior

disorder (RBD) subjects whether bilateral biopsies improve the rate of acquisition of adequate

glandular tissue, whether alpha-synuclein (a-syn) SMG pathology correlates with clinical severity

and/or disease duration, and whether there is a left-right difference in the density of a-syn pathology.

Specific Aim 2. Determine, with a second SMG biopsy in previously biopsied PD and RBD subjects,

whether a-syn pathology density increases, decreases, or remains the same after a 1.5-2 year time

interval and whether there is a correlation between a-syn SMG pathology and clinical and/or disease


Specific Aim 3. Determine whether a-syn pathology density in skin punch biopsies correlates

with clinical measures and increases, decreases, or remains the same after a 1.5-2 year time

interval, and whether the density and changes over time correlate with those found in SMG


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 - Control Group:

  • Aged 21-85 years.
  • No history or exam findings of Parkinson’s disease or other movement disorder.
  • No history of REM Sleep Behavior Disorder (RBD).

Inclusion Criteria - REM Sleep Behvior Disorder (RBD) Group:

  • No history or exam findings of parkinsonism or dementia.

Inclusion Criteria - Parkinson's Disease:

  • Meets MDS diagnostic criteria for Parkinson’s disease

Exclusion Criteria - All Groups:

  • No contraindications to having skin or submandibular gland biopsies.
  • No history or exam findings for dementia.

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

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Jennifer Hill

(480) 301-4750

More information


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