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Clinical Studies


  • Blinded Comparison of Different Alpha-Synuclein Seeding Assays as Cutaneous Biomarkers of Lewy Body Dementias Scottsdale/Phoenix, Ariz.

    The purpose of this study is twofold:

    Specific Aim 1

    • In biopsies of skin from living subjects with DLB, PD without dementia (PD), and PD with dementia (PDD), assess the relative diagnostic sensitivity and specificity of IHC and seeding assay measures of aSyn, relative to normal control subjects.

    Specific Aim 2

    • In second biopsies of skin from subjects with DLB, PD and PDD, assess whether IHC and seeding measures of aSyn progress, regress or remain stable over time, indicating whether these may be useful as measures of therapeutic agent target engagement and disease progression.
  • 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 Scottsdale/Phoenix, Ariz.

    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


  • The Parkinson’s Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort (P2P) Scottsdale/Phoenix, Ariz.

    The Parkinson Progression Marker Initiative (PPMI) is a study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson’s disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

Closed for Enrollment