Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Scottsdale/Phoenix, Arizona: 21-007395
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
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.