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A Study to Provide Feasibility Data for a Novel Method of Defining Patient-Specific Functional Anatomic Targets for Globus Pallidus Internus (GPi) Deep Brain Stimulation (DBS) Placement
Jacksonville, FL
The purpose of this study is to provide feasibility data for a novel method of defining patient-specific functional anatomic targets for Globus Pallidus Internus (GPi) Deep Brain Stimulation (DBS) placement.
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Gastrointestinal Lewy Bodies: A Cause or Effect of Parkinson’s Disease?
Jacksonville, FL
The purpose of this proposal is to explore whether the presence of Lewy pathology in the gastrointestinal tract is associated with functional disturbances such as constipation and dysphagia in both Parkinson’s disease patients and non-Parkinson’s disease patients, and if present in the latter patients whether this relates to the subsequent development of Parkinson’s disease.
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Noninterventional Study Evaluating Parkinson's Disease Diary Use
Scottsdale/Phoenix, AZ
The purpose of this study is to evaluate the impact of the frequency of assessments on the variability over time, reliability, and compliance for the Parkinson's disease (PD) diary in patients with PD in whom medications do not provide adequate control of symptoms.
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Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
Scottsdale/Phoenix, AZ
The potential role of Small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with PD has not previously been examined. Our hypothesis is that SBBO is an important contributor to the development of weight loss in individuals with Parkinson's disease. The investigators propose to 1) examine the role of SBBO in weight loss occurring in patients with PD and 2) determine the response to its treatment with a poorly absorbed antibiotic. The investigators propose to perform a prospective, observational case-control study with an open-label therapeutic component. Cases will be defined as those PD patients who've experienced significant weight ...
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A Study of Biofluids in Parkinson Disease and Related Disorders
Rochester, MN
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.
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Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Scottsdale/Phoenix, AZ
This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic. Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study .
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Functional Magnetic Resonance Imaging (fMRI) During Deep Brain Stimulation (DBS) to Treat Parkinson's Disease
Jacksonville, FL; Rochester, MN
This study is investigating the usefulness of using functional magnetic resonance imaging (fMRI) to monitor brain activation during deep brain stimulation for Parkinson's Disease. The study may determine the relationship between patterns of brain activation and therapeutic outcome and/or side effects.
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A Study to Evaluate the Effectiveness, Safety, and Tolerability of NLY01 in Early-stage Parkinson's Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to assess the safety, tolerability, and effectiveness of NLY01 in subjects with early untreated Parkinson's Disease (PD) and collect data on the effect of the drug on antibody testing (DaT).
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Open-Label Safety Study of ADS-5102 in PD Patients With LID
Scottsdale/Phoenix, AZ
This is a 52-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).
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Clinical Evaluation of the Infinity DBS System
Jacksonville, FL
The purpose of this post market study is to support the chronic clinical performance of the Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads, extensions and related system components.
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A Study to Evaluate Zoledronic Acid for Fracture Prevention in Parkinson's Disease Patients
Rochester, MN
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.
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Electrophysiological Biomarkers for Parkinson's Disease
Scottsdale/Phoenix, AZ
This study will determine the validity of predictive and surrogate biomarkers for the detection of Parkinson's disease and Parkinson's disease cognitive decline.
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Survival and Other Outcomes in Parkinson Disease: Clinical and Genetic
Rochester, MN
The purpose of this study is to answer the question, "Do baseline clinical and/or genetic factors predict survival, and other outcomes (e.g., dementia, hallucinations, wheelchair use) in Parkinson's disease (PD)?"
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A Clinical Study of NLY01 in Patient's With Early Parkinson's Disease
Jacksonville, FL
The purpose of this study is assess the safety, tolerability and effectiveness of NLY01 in subjects with early untreated Parkinson's disease (PD). Evidence suggests NLY01, a pegylated form of exenatide, may be beneficial in PD and is being developed as a potential treatment for neurodegenerative disorders.
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Systemic Synuclein Sampling Study (S4)
Scottsdale/Phoenix, AZ
The purpose of this study is to measure alpha-synuclein in peripheral body tissues and fluids in Parkinson's disease (PD). This may help in developing better treatments for PD patients in the future.
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A Study to Establish a Registry of Deep Brain Stimulation with the VERCISE™ System
Jacksonville, FL
The purpose of this study is to document characteristics of real-world outcomes for Boston Scientific Corporation’s commercially approved Vercise™ System for Deep Brain Stimulation (DBS) when used according to the applicable Directions for Use.
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A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Scottsdale/Phoenix, AZ
A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.
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Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Jacksonville, FL
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
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A Study to Establish a Parkinson’s Disease (PD) Cohort using the Parkinson’s Progression Markers Initiative (PPMI)
Scottsdale/Phoenix, AZ
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.
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A Study to Evaluate the Safety and Effectiveness of BIIB054 in Subjects with Parkinson’s Disease
Jacksonville, FL
The purpose of this study is to evaluate the dose-related safety of BIIB054, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals, to assess the pharmacokinetic (PK) profile of BIIB054 and to evaluate the immunogenicity of BIIB054.
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High Frequency Oscillations in Neurologic Disease
Rochester, MN
This study is designed to evaluate the high-frequency range deep brain oscillations (HFO) as pathologic markers in patients undergoing deep brain stimulation for epilepsy or Parkinson disease. Newly developed technology allows for the chronic recording of these brain signals at the same time as clinical stimulation is occuring. We will learn both whether these HFO correlate with disease activity and whether the HFO change in response to ongoing stimulation (potentially giving insight into the underlying mechanism of action of DBS). Study participants will undergo DBS in the same way as is usually done but will receive this newer battery with ...
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A Study Evaluating Deep Brain Stimulation for Treating Parkinson's Patients with Insomnia
Jacksonville, FL
The purpose of this study is to evaluate the safety, and feasibility of adjuvant high frequency stimulation of the GPe using Deep Brain Stimulation.
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Preclinical Biomarkers of Parkinson's Disease
Jacksonville, FL
To learn more about the biomarkers for preclinical parkinson's disease.
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Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes
Scottsdale/Phoenix, AZ
This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 study as well as additional CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria.
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A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects with Parkinson's Disease (PD) from other Movement Disorders
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether 18F-AV-133 PET scans can be used to differentiate subjects with Parkinson's Disease from other movement disorders.
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A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene Mutation
Scottsdale/Phoenix, AZ
Primary Objectives: - Part 1: To determine the safety and tolerability of GZ/SAR402671 administered orally, as compared to placebo in patients with early-stage Parkinson's disease (PD) carrying a GBA mutation or other pre-specified variants. - Part 2: To determine the efficacy of GZ/SAR402671 administered orally daily, as compared to placebo in patients with early-stage Parkinson's disease carrying a GBA mutation or other pre-specified variants. Secondary Objectives: Part 1: - To assess the pharmacokinetic (PK) profile of oral dosing of GZ/SAR4027671 in plasma when administered in early-stage Parkinson's disease patients carrying a GBA mutation. - To assess the exposure of GZ/SAR402671 ...
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ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
Scottsdale/Phoenix, AZ
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ...
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A Study of Inosine Treatment to Slow Clinical Decline in Patients with Parkinson's Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to determine whether oral inosine dosed to moderately elevate serum urate (from ≤5.7 mg/dL to 7.1-8.0 mg/dL) over 2 years slows clinical decline in early Parkinson's disease.
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A Phase 3 Study to Examine the Effectiveness, Safety and Tolerability of APL-130277 for the Acute Treatment of Motor Fluctuation Episodes in Patients with Parkinson's Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to determine the effectiveness, safety and tolerability of APL-130277 to treat acute motor fluctuation episodes in levodopa responsive patients with Parkinson's disease.
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Transcutaneous Submandibular Gland Biopsy: Feasibility of Repeat Biopsy as a Progression Marker for Parkinson's Disease
Scottsdale/Phoenix, AZ
The purpose of this study is to perform biopsies of one of the glands that make saliva. The biopsied tissue will then be analyzed to see if it has changes that occur in Parkinson's disease. This study will determine whether it is possible to do a second biopsy a few years after a previous biopsy and determine whether there are changes in the biopsy that would allow for analysis of disease progression.
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Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Jacksonville, FL
Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.
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A Study to Examine the Long-Term Safety, Tolerability and Effectiveness of APL-130277 for the Acute Treatment of "OFF" Episodes in Patients with Parkinson's Disease
Scottsdale/Phoenix, AZ
A study in L-Dopa responsive parkinson's disease patients with motor fluctuations ("OFF" episodes), designed to evaluate the long-term safety, tolerability and effectiveness of APL-130277.
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Neurotransmitter Measurements Using Wireless Instantaneous Neurotransmitter Concentration System (WINCS) During Deep Brain Stimulation Neurosurgery
Rochester, MN
In this study, the investigators will monitor extracellular neurotransmitter levels using a probe that is able to perform real time electrochemical detection during deep brain stimulation surgery. The overall question this study is designed to answer is: Are there neurotransmitters released during deep brain stimulation?
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Neurological Diseases Co-existing in Patients with Spasmotic Dsyphonia (SD)
Jacksonville, FL
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
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A Pivotal Clinical Trial of the Management of the Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Idiopathic Parkinson's Disease
Rochester, MN
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
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Mobilaser Study to Help with People Who are Having Problems with Their Gait
Jacksonville, FL
Does use of the Mobilaser reduce freezing of gait (FOG) and stride reduction in patients with Parkinson's disease and Parkinsonism.
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Real-Time Feedback Training to Improve Gait and Posture in People with Parkinson’s Disease
Scottsdale/Phoenix, AZ
This study will investigate the effects of Real-Time Feedback Training and treadmill training to improve gait posture in subjects with Parkinson’s Disease.
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A Study of LY3154207 in Participants With Parkinson's Disease Dementia or Dementia with Lewy Bodies
Scottsdale/Phoenix, AZ
A randomized placebo-controlled trial in individuals with Parkinson's disease dementia to evaluate the safety and efficacy of three doses of study drug LY3154207 in participants with mild-to-moderate Parkinson's disease dementia treated for 12 weeks.
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A Study of the Effect of Deep Brain Stimulation on Constipation and Anosmia in Parkinson Disease
No Locations
The purpose of this study is to investigate the effects of subthalamic nucleus and globus pallidus interna deep brain stimulation on bowel symptoms and the ability to smell things in patients with Parkinson disease and constipation.
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A Study Evaluating Nelotanserin for Treatment of Visual Hallucinations in Subjects with Lewy Body Dementia
Rochester, MN
The purpose of this study is to evaluate the safety and effectiveness of Nelotanserin for the treatment of visual hallucinations in patients with Lewy body dementia.
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A Study to Evaluate Quantitative Phenotypes of Movement Disorders
Jacksonville, FL
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.
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A Study to Understand the Differences of Walking on a Treadmill and Overground in Patients with Parkinson's Disease
Rochester, MN
The purpose of this study is to compare treadmill walking and over ground walking gait characteristics in people diagnosed with Parkinson’s disease.
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Efficacy of Extended Melatonin on sleep cycle in patients with PD and RBD.
Jacksonville, FL
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 ...
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Parkinson's Disease iPS Cell Line Research Consortium
Scottsdale/Phoenix, AZ; Jacksonville, FL
This study is being done to collect skin samples from people with and without neurodegenerative and vascular disorders including Parkinson’s disease (PD), Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), stroke and many others. We will use these skin samples to make and bank (store) a group of cells (cell line) called inducible pluripotent stem (iPS) cells.
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A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
Scottsdale/Phoenix, AZ
This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult subjects with idiopathic PD.
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Study to Evaluate the Pathophysiology of Multiple System Atrophy, Parkinson's Disease, Parkinson's Disease with Autonomic Failure and Dementia with Lewy Bodies Using Microneurographic Recordings of Muscle Sympathetic Nerve Activity
Rochester, MN
The purpose of this study is to understand why patients with multiple system atrophy, Parkinson’s disease, Parkinson’s disease with autonomic failure, and dementia with Lewy bodies have a fall in blood pressure on standing up. It is believed that different patients develop these symptoms for different reasons. The reasons could be:
• damage to nerve supply to the legs
• the autonomic nerves are not working properly
• the brain is not controlling blood pressure or heart rate properly
This study will look at these different reasons.
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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, AZ
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 ...
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A Study to Evaluate Intentional Technology Pairing for Caregivers of Patients with Alzheimer’s Disease and Other Types of Dementia
Rochester, MN
The purpose of this study is to facilitate focus groups to assess/identify important qualities and characteristics that dementia caregivers are looking for in a supportive person, and to design a prototype website for matching current and former caregivers.
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Magnetic Resonance Elastography of Dementia
Rochester, MN
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.
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Synucleinopathies
Rochester, MN
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).
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DaTSCAN Imaging in Aging and Neurodegenerative Disease
Rochester, MN; Jacksonville, FL
The investigators propose using DaTscan in patients with mild cognitive impairment (MCI), Parkinson's disease (PD), dementia with Lewy bodies (DLB), Alzheimer's disease (AD), and other neurodegenerative syndromes and disorders, to test several hypotheses - some confirmatory, and some novel. Such use will provide new data on the potential clinical and research utility of DaTscan in neurodegenerative diseases. The findings on DaTscan will be correlated with clinical diagnoses and other multimodal imaging studies (e.g., MRI, MRS, FDG-PET, and amyloid-PET) to enhance our understanding of neurodegenerative diseases.
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A Study to Evaluate Caregiver Connections via Technology for Patients with Alzheimer's and Other Types of Dementia
Rochester, MN
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.
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A Study to Create a Diagnostic Test for Patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure
Rochester, MN
The purpose of this study is to develop a diagnostic test using tissue biomarkers to provide an accurate diagnosis of alpha-synucleinopathies in patients with Parkinson's disease, Multiple System Atrophy, Dementia with Lewy bodies and Pure Autonomic Failure. Using a simple diagnostic test will improve clinical accuracy in diagnosing, earlier diagnosis, and distinguishing between neurodegenerative diseases.
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Anti-Bullous Pemphigoid Antibodies in Patients with Neurological Disease
Rochester, MN
The purpose of this study is to learn more about Lewy Body disease and a skin condition called Bullous Pemphigoid.
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A Study to Investigate Biomarkers for Phenotyping of Neurodegenerative Disorders
Jacksonville, FL
The primary purpose of this study is to create a Mayo Clinic repository for neurodegenerative disorders such as Parkinson’s disease (PD), Parkinson’s disease dementia and dementia with Lewy bodies (PDD/DLB), multiple system atrophy (MSA), progressive supranuclear palsy (PSP), cortico-basal degeneration (CBD), and other even rarer forms of neurodegeneration.
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North American Prodromal Synucleinopathy Consortium for RBD
Rochester, MN
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 ...
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A Study of the Brain & Body Donation Program
No Locations
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.