Parkinson's Disease & Movement Disorders Clinical Trials
University Hospitals Neurological Institute’s Parkinson’s & Movement Disorders Center is using clinical research to quickly bring advances from the laboratory to the bedside.
Along with Case Western Reserve University School of Medicine, the center is working to refine current techniques and discover new treatments.
- Effect of Covid19 on Parkinson’s Disease, Dementia with Lewy Bodies, and Alzheimer’s Disease Study
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The purpose of this study is to identify changes on a skin punch biopsy or olfactory mucosa (tissue in the back of the nose) sampling, in which small pieces of skin are removed or a swab or brush is placed in the back of the nose, and then tissue is sent to the laboratory for examination. We are interested in learning how a previous Covid19 infection will affect someone’s neurological condition.
- BIA Study
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Study Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in Subjects With Parkinson’s Disease With a Pathogenic Variant in the Glucocerebrosidase (GBA1) Gene
Study ID:2023-01226
Principal Investigator: Steven Gunzler, MD
Study Purpose: The main purpose of this study is to investigate the effects, safety, and tolerability (whether side effects can be handled by a subject) of BIA 28-6156. This study is also meant to find out if the effects, safety, and tolerability are different in people with different forms of the GBA1 gene, which is a genetic characteristic that may be related to a higher risk of getting Parkinson’s disease. Because the symptoms of Parkinson’s disease usually get worse over time, effects will be measured by if, and how, BIA 28-6156 can slow down worsening of the disease.
Basic Eligibility Criteria:
Part A (Genetic Screening) Subjects who satisfy all of the following criteria will be eligible for Part A (Genetic Screening) of the study:- The subject is ≥35 and ≤80 years of age at the time of informed consent.
- The subject has a clinical diagnosis of PD for at least 1 year and for no longer than 7 years before initiation of screening (for Part A), as confirmed by a neurologist using the MDS Criteria for Parkinson’s Disease (Postuma, 2015).
- The subject has a modified Hoehn and Yahr score ≤2.5.
- The subject is receiving symptomatic treatment for PD.
Part B (Double-Blind Treatment)
- The subject has a score ≥22 on the MoCA scale.
- The subject does not have severe motor fluctuations or disabling dyskinesias in the clinical judgment of the investigator.
- The subject has been on stable doses of PD medications (as listed in Table 6) for at least 30 days (at least 60 days for rasagiline) before initiation of screening in Part B (Double-Blind Treatment).
Study Contact: Ashley Hawkins, Ashley.Hawkins2@uhhospitals.org
- Peripheral Tissue Biomarker for Premortem Diagnosis of Lewy Body Dementia
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Parkinsonism can be difficult to diagnose in the early stages of the disease. This study is for participants between 40-89 years of age with with parkinsonism with or without memory and cognitive symptoms, including Parkinson’s disease, progressive supranuclear palsy, corticobasal degeneration, and dementia with Lewy bodies.
- Skin Biopsy Study
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The purpose of this study is to determine whether identification of misfolded proteins in the skin will help to determine what sort of parkinsonism someone has. We seek to demonstrate whether someone has a synucleinopathy such as Parkinson's disease (PD), multiple system atrophy (MSA), or dementia with Lewy bodies(DLB), as opposed to a tauopathy such as progressive supranuclear palsy (PSP) or corticobasal degeneration (CBD) or no parkinsonism at all (control).
- PD GENEration Study
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Parkinson’s Foundation PD GENEration Genetic Registry
The purpose of this study is to do genetic testing in Parkinson’s disease (PD) to investigate the role of genetics, help improve our understanding of PD and help participants and their clinicians understand their genetic status to improve care.
- PRISM Early-Stage Parkinson’s Disease Study
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The PRISM Parkinson’s Research Study is evaluating an investigational drug to determine if it might slow down the progression of Parkinson’s disease (PD). Patients who enroll in this study will receive the study drug weekly over a period of 36 weeks. Participants will have about 10 scheduled in-person visits at the study center and 5 scheduled telephone visits. Those who enroll can expect to be in the study for a total of 44 weeks.
- Saliva Collection for RT-QuIC Analysis in Parkinsonism and Controls and other Neurodegenerative Disorders
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SPARTA ID: STUDY20230358
Principal Investigator: Steven Gunzler, MD
Study Coordinator: Ashley Hawkins, Kailey Sajewski (216-844-1800)
Study Purpose: This study will use saliva specimens to develop tests that will help diagnose and understand early detection of Parkinson’s disease (PD) and other parkinsonism. These samples will be used to learn more about parkinsonism and to find ways to diagnose and measure severity of parkinsonism.
Basic Eligibility Criteria:
- 30-95 years of age
- Decisional capacity to consent
- SPARX3 Study
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Study in Parkinson Disease of Exercise
The purpose of this study is to compare the effects of two different levels of exercise intensity and to learn more about effects of aerobic exercise on people with Parkinson’s disease (PD). This study will help us better understand what exercise guidelines should be used in the future.
- TOPAZ Study
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The purpose of the TOPAZ study is to determine whether zoledronic acid, an approved bone strengthening medication for osteoporosis, can prevent fractures and decrease the risk of dying in people with Parkinson’s disease and other parkinsonism. The information learned in this study will help doctors understand whether they should treat their patients with PD with zoledronic acid.
- Vagus Nerve Ultrasound Study
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Comparison of vagus nerve ultrasound (VNUS) with parasympathetic autonomic function in patients with Multiple System Atrophy and Parkinson’s disease.
Principal Investigator: Hemani Ticku
Study Purpose: To directly measure the vagus nerve cross sectional area (CSA) using high resolution Neuromuscular Ultrasound (NMUS) in patients with Parkinson’s disease (PD) and Multiple System Atrophy (MSA) who have autonomic dysfunction based on clinical signs and symptoms and COMPASS-31 and SCOPA-AUT severity scores and compare it with the parasympathetic response on gold standard autonomic tests.
Basic Eligibility Criteria:
- Age 40 – 89
- Patient able to provide informed consent
- Clinically probable MSA and clinically established MSA – based on Movement Disorder Society criteria for diagnosis.
- Clinical diagnosis of Parkinson Disease with and without orthostatic hypotension
Study Coordinator: Hemani Ticku (216-844-7602)