Clinical Trials

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

progression.

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

biopsies.

The purpose of this study is to optimize profile questionnaire and matching algorithm developed in Phase I and implement in final website design, and to determine if algorithmically matched participants have statistically significant increase in match satisfaction and self-reported sense of resiliency and quality of life over randomly matched caregivers.

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.

The purpose of this study is to evaluate the use of a single infusion of zoledronic acid-5 mg (ZA) vs. placebo for the prevention of fractures in men and women aged 65 years and older with Parkinson's Disease with 2 years of follow-up.

The purpose of this study is to determine if adaptive rhythmic auditory stimulation (ARAS) is a safe means of improving gait; i.e., fewer falls, abrupt accelerations/decelerations in patients with movement disorders. Furthermore, we aim to provide patients with a safe environment in which they can safely navigate through an enjoyable experience (guided art tour) that provides exercise, social engagement, and exposure to art.

The goals of the study are to prospectively evaluate clinical and laboratory biomarkers of multiple system atrophy and Parkinson’s disease at early clinical disease, at a premotor stage (PAF), and even at a prodromal stage (RBD).

The purpose of this study is to analyze DNA and genome-wide analyses, as well as metabolomics and biomarker studies, from patients in the spectrum clinically diagnosed Parkinson disease, Lewy Body disease and related diseases. This would include persons experiencing the earliest manifestations to those with established Parkinsonism. 

The purpose of this study is to develop and test the effectiveness of an investigational imaging technique called magnetic resonance elastography (MRE) to measure the stiffness (mechanical properties) of tissues.

The purpose of this study is to investigate if spasmotic dsyphonia (SD) patients have neurological diseases like dystonia, cervical dystonia, Parkinson’s disease more than normal population

Most individuals with rapid eye movement (REM) sleep behavior disorder (RBD) develop additional
neurological symptoms and are subsequently diagnosed with overt synucleinopathies, including dementia with
Lewy bodies (DLB), Parkinson disease (PD), and multiple system atrophy (MSA), indicating that RBD
represents a prodromal stage of synucleinopathy. RBD therefore offers a window of opportunity to intervene
with neuroprotective treatments at the earliest stages of disease when treatment is most likely to be effective.
Recognizing the importance of early intervention, key federal agencies focused on neurodegenerative disease
have proposed high priority recommendations for prodromal aspects of synucleinopathies, including
specifically RBD, to prepare for clinical trials. The North American Prodromal Synucleinopathy (NAPS)
Consortium began in 2018 to plan for neuroprotective clinical trials in RBD. The NAPS Consortium, currently at
10 sites, has thus far enrolled 215 participants with polysomnogram-confirmed RBD, and has successfully
performed comprehensive and standardized assessments and biofluids collection. The North American
Prodromal Synculeinopathy Consortium for RBD, Stage 2 (NAPS2) program represents an integrated
expansion of NAPS to support a longitudinal, prospective study of RBD, to address key gaps currently
prohibiting neuroprotective clinical trials in RBD. NAPS2 will establish enhanced infrastructure to support longterm
research in prodromal synucleinopathies.