Clinical Trials

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 primary aim of this study is to compare effectiveness of immediate versus extended-release melatonin as a supplement affecting the sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ).  The secondary aim is to evaluate the superiority and effect of immediate and extended-release melatonin versus not taking any melatonin on sleep cycle among patients with Parkinson’s disease as assessed by modified Mayo Sleep Questionnaire (MSQ).

Rapid eye movement (REM) sleep behavior disorder (RBD) is very common in patients with Parkinson disease and manifests with the loss of REM sleep atony, vigorous motor jerks, nocturnal vocalizations and dream enactment. Melatonin is commonly used as symptomatic management for RBD, but its efficacy is only supported by observational studies and a few controlled trials with relatively small number of participants. Melatonin may influence sleep cycle and affect clinical manifestations of RBD by decreasing muscle tonicity during REM sleep.  

Sleep normally cycles through REM and non-rapid eye movement (NREM) stages on average 4 to 6 times during the night. As the night progresses, fewer NREM stages occur, and the duration of REM sleep episodes increases. In a US-based randomized, crossover pharmacokinetic (PK) evaluation study,  an extended-release melatonin (ERM) exceeded the targeted sleep maintenance threshold for a median of 6.7 hours, compared with 3.7 hours with the immediate- release melatonin (IRM). We hypothesize that extended-release melatonin would be more helpful in regulating sleep cycle and affecting RBD, since REM density increases as night progresses. To our knowledge, no study that compares the efficacy of extended versus immediate-release melatonin on sleep cycle and its effect on RBD in patients with Parkinson disease has been done.

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 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.

This study will determine the validity of predictive and surrogate biomarkers for the detection of Parkinson's disease and Parkinson's disease cognitive decline.

The purpose of this study is to study the structure and biochemistry of the brain and/or bodily fluid and tissue after death.  Comparison of specimens from normal and diseased individuals provide essential clues that lead to a greater understanding of the diseased state which, in turn, will lead to new ideas for therapy.