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
A Study of Remternetug Versus Placebo in Early Alzheimer’s Disease Participants at Risk for Cognitive and Functional Decline
Study sponsor: Eli Lilly
Location: Center for Memory and Aging, Neuroscience Center
Phase of Study: III
Purpose of study: The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer’s disease occurring in participants receiving study drug compared to placebo.
Inclusion Criteria:
– Age 55-80
– Have at least 1 reliable study partner
– Have a plasma P-tau at first visit
Exclusion Criteria:
– Have dementia
– Cannot have an MRI
– Are enrolled in other medical research
Study Contact:
Meghan O’Brien
(651) 493-6363
ClinicalTrial@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
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
