A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of NEU-411 in Companion Diagnostic-Positive Participants with Early Parkinson’s Disease (NEULARK)
Study sponsor: Neuron23, Inc.
Location: Struthers Parkinson’s Center
Phase of Study: II
Purpose of study: This is a randomized, placebo-controlled, study in participants with early PD who have elevated leucine-rich repeat kinase 2 (LRRK2)-pathway activity assessed using a co-developed investigational CDx. Only participants who test positive using the investigational CDx will be included in the study, including both individuals with rare variants and others with predicted elevations in LRRK2 activity. The study will evaluate safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of orally administered NEU-411, a study drug as compared to placebo.
Inclusion Criteria:
– The participant must test positive (LRRK2-driven) using the investigational CDx performed at the designated central laboratory
– Aged 50-80 years at time of Screening
– Participants are not currently on nor anticipated to require dopaminergic therapy (e.g., levodopa) within the next 12 months
– Participants who have a body mass index (BMI) of 18-32 kg/m2
Exclusion Criteria:
– Parkinsonian syndromes due to a secondary etiology, including parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body (LB) dementia
– Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) >8%
– Reside in a skilled nursing facility
Study Contact:
Carrie Weaver
(651) 495-6363
ClinicalTrials@HealthPartners.com
Caregiver Education Interviews
Study sponsor: University of Minnesota
Purpose of study: The Caregiver Education study is conducting research interviews to learn more about what types of support caregivers of people with a brain or spine condition might want from their loved one’s care team. Specifically, the study focuses on support that could be provided by rehabilitation therapists, such as physical, occupational, or speech therapists. Study results will help HealthPartners provide better training and support for caregivers.
If you have received an invitation and would like to participate, please contact the Caregiver Education Interviews study team:
(952) 967-5390
Evaluation@HealthPartners.com
Light vs. Moderate Intensity Exercise in Individuals with Myasthenia Gravis
Study sponsor: HealthPartners Neuroscience Center/HealthPartners Institute
Location: Neuroscience Center
Phase of Study: I
Purpose of study: Myasthenia gravis (MG) is a chronic neuromuscular, autoimmune disease characterized by muscle weakness and fatigue. Recent reviews have concluded that exercise is safe in individuals with MG, and can improve muscle strength, function, and quality of life (QOL), and reduce fatigue. The purpose of this study is to test the difference between light and moderate intensity exercise on health outcomes in people with MG. Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders and led by Exercise Physiologists at the HealthPartners Neuroscience Center.
A total of 20 people with generalized MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks either in person or remote via video. Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity.
Inclusion Criteria
– Age 18-80
– Diagnosis of generalized MG
– Obtain medical clearance from the study neurologist or their physician
Exclusion Criteria
– Significant cognitive impairment of any etiology that would impact study participation
– History of heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion
– History of any serious neurological, psychiatric, or substance use disorders that would impact study participation.
– Women who are currently pregnant or planning to become pregnant during the study
– Any other medical conditions that could affect their ability to participate in exercise for the study duration (as determined by study investigators).
– Active participation or past participation ≤3 months in any other interventional research study
Study Contact:
Samantha Sherman
(651) 495-6367
Samantha.J.Sherman@HealthPartners.com
Minnesota Regional Spinal Cord Injury Model System
Study Sponsor: National Institute on Disability, Independent Living, and Rehabilitation Research
Location: Regions Hospital
Purpose of study: The purpose of the study is to contribute to the Spinal Cord Injury model systems (SCIMS) national database through longitudinal assessment of long-term health and psychosocial outcomes after acquired spinal cord injury (SCI). Patients will be asked to complete questionnaires to collect demographic information about their injury, general health, and quality of life. There is also an optional sample collection to collect blood to be stored for future genetic testing.
Inclusion Criteria:
– Presence of an external traumatic event that results in a spinal cord injury, including surgical procedures, radiation, and medical complications.
– Temporary or permanent loss of sensory and/or motor function as a result of the traumatic event.
– Admission to the system within one year of injury
Exclusion Criteria:
– Must not have previously been treated at another model system for the injury.
– Must not have completed an organized rehabilitation program prior to the admission to the system.
Study Contact:
Amanda Herrmann, PhD
(651) 495-6363
ClinicalTrials@HealthPartners.com
Parcel-guided Transcranial Magnetic Stimulation for Anxiety in PD
Study Sponsor: HealthPartners Institute
Location: Neuroscience Center
Purpose of study: Parkinson’s disease (PD) is the second most common neurodegenerative disease after Alzheimer’s dementia. Anxiety in PD is common, has major effects on quality of life and contributes to increased disability. The reported prevalence of anxiety in PD ranges widely and is estimated up to 40%. TMS has been shown to be effective and safe in anxiety and general anxiety disorder (GAD), but there is only limited data available for TMS treatment of anxiety in PD. This study is to assess the feasibility and acceptability of TMS treatment for Anxiety in PD.
Inclusion Criteria
– Idiopathic PD
– Anxiety based on the Parkinson’s anxiety scale
– Between 40 and 90 years old
– Additional inclusion criteria apply. Please contact the study team for more information.
Exclusion Criteria:
– Seizure disorder
– Non-English speaking
– Unable to tolerate imaging or inability to have imaging due to implants or metal
– Additional exclusion criteria apply. Please contact the study team for more information.
Study Contact:
Clarissa Howe
(651) 495-6363
ClinicalTrials@HealthPartners.com
Parkinson’s Foundation PD GENEration Genetic Registry
Study sponsor: Parkinson’s Foundation
Location: Struthers Parkinson’s Center
Purpose of study: Purpose: to help improve our understanding of Parkinson’s Disease and help participants and their clinicians understand their genetic status to improve care, which includes determining eligibility for clinical trial participation. Study includes a baseline visit (in-person or by video) and a genetic counseling visit (by video, phone, or in-person) to discuss your test results with the study doctor.
Inclusion Criteria:
– Diagnosis, or probable diagnosis, for Parkinson’s Disease.
– Capacity to give full informed consent.
– Participant must have residential address in MN or Wisconsin.
Exclusion Criteria:
– Received a blood transfusion within the past 3 months.
– Received a bone marrow transplant within the past 5 years.
– Active blood cancer, such as lymphoma or leukemia.
– Under the age of 18.
Study Contact
Taylor Billeadeau
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04994015
Personalized Accelerated Theta Burst Transcranial Magnetic Stimulation in Mild Traumatic Brain Injury
Study Sponsor: Minnesota Office of Higher Education
Location: Neuroscience Center
Purpose of study: Persistent post-concussive symptoms (PPCS) involve an array of physical, cognitive, and behavioral symptoms lasting more than a month after mild traumatic brain injury (mTBI). 34-44% of people with mTBI or concussion present with a considerable burden of PPCS 3-6 months after injury. There is currently no standardized treatment for PPCS, nor FDA approved medication for any neuropsychiatric or neurocognitive symptoms associated with mTBI. Transcranial magnetic stimulation (TMS) shows promise as a treatment for PPCS. The purpose of this study is to develop and evaluate the method of personalization of TMS for PPCS and assess the feasibility and acceptability of personalized TMS for PPCS.
Inclusion Criteria:
– Clinical diagnosis of mTBI at least 4 weeks prior but not exceeding 12 months prior to the time of screening
– Age 18-65 years at the time of mTBI
– High burden of post concussive symptoms at the time of screening.
Exclusion Criteria:
– Inability to tolerate imaging; contraindication of imaging due to implants or metal.
– Seizure disorder, active alcohol or substance use disorder.
– Inability to speak and read English.
– Subject is pregnant or breast feeding
– Subject has participated in a clinical interventional trial in the last 3 months
Study Contact:
Samantha Sherman
(651) 495-6363
ClinicalTrials@HealthPartners.com
