A Randomized, Double-Blind, Placebo-Controlled Trial of CVN424 in Early Parkinson’s Disease
Principal Investigator: Sotirios Parashos, MD, PhD
Study sponsor: Cerevance Beta, Inc.
Location: Struthers Parkinson’s Center
Purpose of study: The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.
Inclusion Criteria:
– Diagnosis of Parkinson’s disease
– At least 30 years old
– Not receiving anti-parkinsonian therapy and not expecting to require it for the duration of the trial (approximately 4 months)
– Freely ambulatory with or without an assistive device
Exclusion Criteria:
– Diagnosis of secondary or atypical parkinsonism
– Diagnosis of parkinsonian motor signs or symptoms for 4 or more years
– Previous surgical procedure for PD
Study Contact:
Renee Rosenberg
(651) 495-6360
ClincialTrials@HealthPartners.com
A Two Part, Observational Basket Study to Determine Usability, Validity and Biomarker Discovery for Mobile EEG, Wearable and Device Collected Objective Measurement of Disturbed Sleep and Neurologic Disorders (LEARNS)
Principal Investigator: Sotirios Parashos, MD, PhD
Study sponsor: Koneksa Health
Location: Neuroscience Center, Struthers Parkinson’s Center
Purpose of study: The Disease Progression Study is an observational study to evaluate detection of Parkinson’s progression, usability, compliance, validity, and reliability of digital assessments along with digital biomarker/eCOA discovery. The study
The Disease Progression Study part in Parkinson’s Disease has a duration of approximately 12 months.
Inclusion Criteria:
– Clinically established Parkinson’s disease
– 18-85 years of age
– BMI 18-40 kg/m2
Exclusion Criteria:
– Planning to enroll in a clinical trial for disease modifying therapy that will overlap with this trial
– Increased risk of falling (defined as >6 falls in last 12 months)
– Intracranial metallic/magnetic devises (such as a cochlear implant or deep brain stimulator)
– Implanted active device (such as a pacemaker or defibrillator)
Study Contact:
Renee Rosenberg
(651) 495-6363
ClinicalTrials@HealthPartners.com
Brain Health Study Interviews
Principal Investigator: Leah Hanson, PhD, Rebecca Rossom, MD, MS
Study sponsor: National Institutes of Health
Purpose of study: The Brain Health Study is conducting interviews to learn more about the care experience of people who have been recently evaluated for concerns of memory loss and have a family member or partner helping with their care.
If you have received an invitation and would like to participate, please contact the Brain Health Study interview team:
952-967-6875
BrainHealthStudy@HealthPartners.org
Continuous wearable monitor for the detection and release of freezing of gait
Principal Investigator: Martha Nance, MD
Study sponsor: National Institute on Aging
Location: Center for Memory and Aging, Neuroscience Center, Struthers Parkinson’s Center
Phase of Study: I
Purpose of study: The purpose of the study is to test an insole and cueing device and determine whether it can reduce the number and length of FOG events in people living with PD. If you choose to participate, you will have an initial phone screening to evaluate your eligibility for the study, followed by two in-person visits and weekly phone calls over 5 weeks. You will also be given the insole device to take home and use within your home and the community for 5 weeks. Your participation will take approximately 7 weeks total, depending on when the in-person visits are scheduled.
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
-Ability to provide and provision of signed and dated informed consent form.
-Age 45-80
-Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
-Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and NFOG-Q.
-Able to complete a 2-minute walk test at the pre-treatment visit.
-Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
-Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study:
-Non-English speaking
-History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
-Other significant neurological disorders that may affect participation or performance in the study.
-Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
-Hallucinations
-Non-ambulatory
-Legally Blind
-Symptomatic hypotension
Study Contact:
Clarissa Howe
(651) 495-6368
Clarissa.M.Howe@HealthPartners.com
Intranasal Insulin in Parkinson’s Disease (INI-PD)
Principal Investigator: Julia Johnson, MD
Study Sponsor: Struthers’s Parkinson’s Center – Saint Paul, HealthPartners Neuroscience Center
Location: Struthers’s Parkinson’s Center – Saint Paul
Purpose of study: The purpose of this study is to investigate the safety and tolerability of insulin delivered as a nasal spray (intranasally) when administered to individuals with Parkinson’s disease (PD). In addition, the effect of intranasal insulin on motor function, cognitive function and mood in PD will be investigated.
There will be a total of three in-person study visits and at least two phone visits over the course of 2 months at the HealthPartners Neuroscience Center located at 295 Phalen Boulevard, St. Paul, MN 55130. Each participant is on the study medication or placebo for 3 weeks. A designated care partner/family member may be needed to be present for all 3 visits and to help with dosing every day, 1-2 times daily, for 3 weeks.
Inclusion Criteria:
– Diagnosis of Parkinson’s Disease
– Have previously undergone a brain CT or MRI as part of receiving a Parkinson’s diagnosis
–If needed, have a dedicated family member of caregiver who can attend all study visits
Exclusion Criteria:
–Currently taking insulin for diabetes or are allergic to insulin
–History of other central nervous system disorders
Study Contact:
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04251585
Light vs. Moderate Intensity Exercise in Individuals with Myasthenia Gravis
Principal Investigator: Amanda Herrmann, PhD
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. 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
– Regular exercise participation within the month prior to study enrollment or any outside exercise participation during the study intervention period
– 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
Principal Investigator: Leah Hanson, PhD
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
Principal Investigator: Martha Nance, MD
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
Renee Rosenberg
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04994015
Randomized, Double-blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lenrispodun as Adjunctive Therapy in the Treatment of Patients with Motor Fluctuations due to Parkinson’s Disease
Principal Investigator: Sotirios Parashos, MD, PhD
Study Sponsor: Intra-Cellular Therapies, Inc.
Location: Struthers Parkinson’s Center – Golden Valley
Purpose of study: The purpose of this study is to compare the efficacy of lenrispodun 30 mg administered once daily as adjunctive therapy to stable doses of existing levodopa therapy with that of placebo as adjunctive therapy to stable doses of existing levodopa therapy in patients with motor fluctuations due to Parkinson’s disease.
Patients must:
-Be at least 40 years old
-Be diagnosed with Parkinson’s Disease
-Have a clinically meaningful response to levodopa
Carrie Weaver
(651) 495-6363
ClincialTrials@HealthPartners.com
For more information, please visit the study’s clinicaltrials.gov site at: https://clinicaltrials.gov/study/NCT05766813
Virtual Reality Cognitive Therapy for Alzheimer’s Disease
Principal Investigator: Leah Hanson, PhD
Study sponsor: Clarity Tek
Location: Center for Memory and Aging, Neuroscience Center
Purpose of study:Alzheimer’s disease (AD) and Alzheimer’s disease-related Dementias (ADRD) resulting in cognitive decline affects more than 5.8 million Americans. Given the impact of AD/ADRD on people’s quality of life, there is a great need for therapies focused on cognition. In this study we will test the feasibility, usability, and acceptability of a novel Virtual Reality Cognitive Therapy (VRCT) developed by ClarityTek, Inc. The VRCT will focus primarily on skills that impact instrumental activities of daily living (e.g., taking medications, shopping). Thirty-six individuals with mild to moderate AD/ADRD will be enrolled. Participants and their care partners will utilize the VRCT within their home for 30 minutes, 3 times per week, for seven weeks.
Inclusion Criteria:
– Ability to provide and provision of signed and dated informed consent form
– Age 30-89
– Diagnosis of mild cognitive impairment (MCI), probably Alzheimer’s Disease (AD), or Alzheimer’s disease Related Dementias (ADRD)
– Montreal Cognitive Assessment (MoCA) score of 11-25
Exclusion Criteria:
– Non-English speaking
– History of seizure disorder, vertigo disorder, or severe motion sickness
– Severe visual/hearing impairment, aphasia, or facial injury
– Unwilling to participate in all study related activities
– History of any other serious condition that may limit their ability to participate in the intervention, as determined by the investigator
Study Contact:
Clinical Trials office
(651) 495-6363
ClinicalTrials@HealthPartners.com
For more information, please visit the study’s clinicaltrials.gov site at: https://clinicaltrials.gov/study/NCT05788848
