A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF K0706 IN SUBJECTS WITH EARLY PARKINSON’S DISEASE
Principal Investigator: Sotirios Parashos, MD, PhD
Study sponsor: Sun Pharma Advanced Research Company Limited (SPARC)
Location: Struthers Parkinson’s Center
Phase of Study: II
Purpose of study: THE GOAL of the study is to see if vodobatinib can keep Parkinson’s Disease from getting worse.
Patients must:
• Be at least 50 years old
• Have received a diagnosis of Parkinson’s Disease
within the past 3 years
• Be willing to refrain from symptomatic treatment
such as Sinemet during the study
Inclusion criteria:
-The subject has given written informed consent and is willing to participate in the study;
-Subject is able to understand and comply with all study procedures (requires literacy in available language of all patient-reported outcome measures);
-Males or females aged ≥ 50 years;
-Body mass index (BMI) greater than 18.5 kg/m2 and less than 45 kg/m2;
-Diagnosed with “Clinically Probable PD” according to the MDS clinical diagnostic criteria, with documented diagnosis of PD per treating physician’s records within three years of the Screening visit. Disease severity according to modified Hoehn & Yahr stage ≤ 2;
-Projected to not require to start dopaminergic therapy within 9 months from Baseline;
-Female subjects must be not of childbearing potential, e.g., documented evidence that they are surgically sterile (e.g., hysterectomy, partial hysterectomy, bilateral oophorectomy, bilateral tubal ligation), or post-menopausal (at least 12 months since last menses) prior to Screening with serum Follicular Stimulating Hormone (FSH) ≥40 mIU/mL).
-Male subjects enrolled in the study should not father a child and are advised to prevent passage of semen to their sexual partner during intercourse using an effective method, as judged by the Investigator, for the duration of the study and for 3 months after the last dose of study drug.
-Willingness to undergo lumbar puncture and skin biopsy for future testing of substances related to PD or K0706 target engagement. (For subjects at sites participating in the Biomarker sub-study)
Exclusion Criteria:
-Current, or within 60 days of Screening, use of any prescription, investigational, or over the counter medication for the symptomatic treatment of PD or to slow the progression of PD. Treatment with Monoamine Oxidase B (MAOB) inhibitors will be allowed if the dose is stable for at least 30 days prior to Screening and subjects agree to remain on it for the duration of the study;
-Prior use of dopaminergic therapy (e.g., levodopa, dopamine agonist, amantadine) for 30 or more days any time in the past;
-A diagnosis of a significant central or peripheral nervous system disease affecting the subject’s cognition or motor function at any time, such as another neurodegenerative disorder, multiple sclerosis or stroke. This does not include transient neurological deficits such as transient ischemic attacks or migraine aura;
-A diagnosis of a medical condition that could interfere with interpretation of the MDS-UPDRS during the trial (e.g., musculoskeletal disorders);
-Contraindications to receiving an MRI;
-Contraindications to receiving a DaT SPECT scan (e.g., hypersensitivity to the active substance, any of the excipients, or iodine) if a new DaT SPECT scan is required for the study;
-Most recent DaT SPECT scan not compatible with PD (i.e., Scans Without Evidence of Dopaminergic Deficit [SWEDD]) based on a central reading by a study physician;
-MRI of the brain performed after onset of PD suggestive of secondary Parkinsonism (e.g., subdural hematoma, normal pressure hydrocephalus, or infarcts of the basal ganglia);
-Severe tremors as defined by a score of “severe” on any of the MDS-UPDRS Parts 2 or 3 tremor severity (not constancy) items;
-Montreal cognitive assessment score < 25;
-History of any surgery on the brain itself including deep brain stimulation for PD (note this does not include surgeries on the skull that do not affect the brain, e.g., small meningioma removal);
-History of hypersensitivity (e.g., bronchospasm, anaphylaxis, serious drug rash) to contents of the study drug or other tyrosine kinase inhibitors;
-Clinically significant or unstable psychiatric or medical condition, vital sign, or laboratory abnormality that in the opinion of the investigator interferes with participation in the study;
-Any clinically significant cardiac abnormality that is in the opinion of the investigator. This would include myocardial infarction in the six months prior to screening, or a significant ECG abnormality, including heart-rate corrected interval QT (QTc) based on Fridericia’s correction formula > 450 milliseconds for males and > 470 milliseconds for females;
-History or presence of any gastrointestinal disorder or malabsorption syndrome, which might affect absorption of study drug;
-Subject’s report of recent (within the previous 6 months) illicit drug use (other than marijuana), or intake of alcohol that is excessive in the opinion of the investigator, or positive urine drug screen at Screening;
-Subject’s report of use of marijuana within one month of Screening or lack of willingness to forgo use of marijuana during the trial;
-History of surgery within 4 weeks prior to Screening visit or expectation of a planned surgical or invasive diagnostic procedure during the course of the study;
-Participation in other investigational drug trials within 30 days prior to Screening;
-Any concomitant medication or medication excluded that could put subject at risk, or interfere with study evaluations (Protocol Section 7.4);
-Recent use of medications that can cause Parkinsonism and suspicion of the investigator that it could have worsened the subject’s Parkinsonism. This includes neuroleptics (e.g., olanzapine, risperidone, haloperidol), some anti-nausea medications (e.g., prochlorperizine, metoclopramide) and others (e.g., flunarizine, methyldopa);
-Use of medications that affect the dopaminergic system within 60 days of Screening. This includes stimulants (e.g., methylphenidate, amphetamine derivatives, modafinil) and Monoamine Oxidase A (MAOA) inhibitors (e.g., phenelzine, and tranylcypromine). Note that antidepressants are acceptable as long as the subject has remained on them at a stable dose for over 60 days prior to Screening and plans to remain on them through the study;
-Any malignant disease (other than basal cell carcinoma of the skin) with evidence of disease within the past 5 years and with the potential for recurrence;
-Female subjects presently lactating;
Study Contact:
Rebekah Heisick
(952) 993-5903
Rebekah.Heisick@parknicollet.com
A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson’s Disease
Principal Investigator: Sotirios Parashos, MD, PhD
Study sponsor: Inhibikase Therapeutics, Inc.
Location: Struthers Parkinson’s Center – Golden Valley
Purpose of study: The goal of the study is to see if IkT-148009 can keep Parkinson’s Disease from getting worse.
Inclusion Criteria:
-Be 30-75 years old
-Be diagnosed with Parkinson’s Disease
-Not be receiving any anti-parkinsonian therapy
Study Contact:
Rebekah Heisick
(952) 993-5903
Rebekah.Heisick@ParkNicollet.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT05424276
A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson’s Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and its Individual Components BK-JM-201
Principal Investigator: Sotirios Parashos, MD, PhD
Study sponsor: Bukwang Pharmaceutical Co., Ltd.
Location: Struthers Parkinson’s Center – Golden V alley
Phase of Study: II
Purpose of study: This is a study for Parkinson’s disease patients with dyskinesia to assess the efficacy and safety/tolerability of fixed dose combinations of JM-010 and its individual components.
Patients must:
– Be 18 to 80 years of age
– Be diagnosed with Parkinson’s disease (PD) and taking a stable dose of levodopa 3 to 6 times daily
– Have muscle twitches and twisting movement (dyskinesia) that is moderately to completely disabling (more than one hour per day)
Study Contact:
Rebekah Heisick
(952) 993-5903
Rebekah.Heisick@parknicollet.com
For more information, please visit the study’s clinicaltirals.gov site at:
https://clinicaltrials.gov/study/NCT04377945
ENVISION
Principal Investigator: Marcel Hungs, MD, PhD
Study Sponsor: Biogen MA Inc. (Biogen)
Location: HealthPartners’s Neuroscience Center, Saint Paul, MN 55130
Purpose of study: Research suggests that a cause of Alzheimer’s disease (AD) may be an abnormal build-up of a protein in the brain called amyloid beta. We are conducting the ENVISION study to confirm if this study drug-Aducanumab- that has been designed to reduce this build-up can help people with Mild Cognitive Impairment (MCI) due to AD or mild AD dementia compared to placebo.
Inclusion Criteria:
– Have Mild Cognitive Impairment due to Alzheimer’s disease or mild Alzheimer’s dementia
– Aged 60-85
Study Requirements:
– Length of study commitment: 130 weeks (2 and ½ years)
– Requirements: you will need to visit a study clinic approximately 40 times so that we can monitor your general health and condition with health assessments such as blood tests, brain MRI scans, neurological examinations, urine tests and vital signs. You will also have up to eight follow-up phone calls.
Study Contact: If you would like to know more about this study, please contact Carrie Weaver at 651-495-6370 or email carrie.a.weaver@healthpartners.com.
Clinical Trials Link (to clinical trials.gov): https://clinicaltrials.gov/stiudy/NCT05310071
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
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
Rebekah Heisick
(952) 993-5903
Rebekah.Heisick@parknicollet.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 40-80 years old
-Be diagnosed with Parkinson’s Disease
-Have a clinically meaningful response to levodopa
Study Contact:
Rebekah Heisick
(952) 993-5903
Rebekah.Heisick@parknicollet.com
For more information, please visit the study’s clinicaltrials.gov site at: https://clinicaltrials.gov/study/NCT05766813
Role of Attention in Gait and Balance in Parkinson’s Disease
Principal Investigator: Sotirios Parashos, MD, PhD
Study sponsor: Parkinson’s Foundation
Location: Struthers Parkinson’s Center
Purpose of study: People diagnosed with Parkinson’s Disease, even in the early course of the disease, have cognitive deficits without dementia. Cognitive deficits have been correlated with gait and balance difficulties. The purpose of this study is to determine the impact of attention on gait and balance in individuals with early Parkinson’s Disease without dementia.
This study will compare those with Parkinson’s disease to those without Parkinson’s disease; thus, healthy volunteers (spouses/partners/friends/loved ones) 40 years of age or older are welcome to participate but not required. Participation in this study will involve one visit.
Inclusion Criteria:
– Able to walk 6 minutes without use of a walker or wheelchair (cane or walking sticks are okay).
– Those with Parkinson’s disease, age 30 or older at time of diagnosis.
– Those without Parkinson’s disease, age 40 or older at time of testing.
– If on medication for Parkinson’s disease and/or memory enhancing medication, should be on a stable regimen for at least 30 days
prior to participation.
Exclusion Criteria:
– Unable to walk without use of a walker or wheelchair for 6 minutes.
– Late-stage Parkinson’s disease.
Study Contact
Rebekah Heisick
(952) 993-5903
Rebekah.Heisick@parknicollet.com
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