A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients with Prodromal to Mild Alzheimer’s Disease
Principal Investigator: Michael Rosenbloom, MD
Study Sponsor: Genentech, Inc.
Phase of Study: Phase 2
Location: HealthPartners Center for Memory and Aging, HealthPartners Institute
Purpose of Study: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of MTAU9937A in patients with prodromal or mild Alzheimer’s disease, ages 50-80. Study drug administration will occur every 2 weeks for the first three doses and every 4 weeks thereafter for approximately a year and a half altogether. During this time, individuals will periodically complete cognitive assessments and lab draws to assess safety, efficacy, and clinical outcomes.
Recruitment Status: Active, Not Recruiting
Study Contact:
(651) 495 – 6363
ClinicalTrials@HealthPartners.com
A Single Center Feasibility Study of Intranasal Insulin in Frontotemporal Dementia
Principal Investigator: Michael Rosenbloom, MD
Study Sponsor: HealthPartners Center for Memory and Aging
Location: HealthPartners Neuroscience Center
Phase of Study: Phase 2
Purpose of Study: This study is a single-center, non-randomized, no placebo controlled, feasibility study to assess the safety and tolerability of intranasal insulin in patients with Frontotmporal Dementia (FTD). We will also be evaluating feasibility of using University of California, San Francisco Memory and Aging Center’s EXAMINER battery as a cognitive outcome measure in FTD patients and evaluating the study location’s capacity to recruit for FTD subjects. All enrolled subjects will be asked to self-administer intranasal insulin twice a day, every day for 4 weeks; the estimated duration of subject participation is 9 weeks, as we will be asking subjects to attend 3 in-person visits and be available for 2 phone visits.
Eligible Diagnoses: Frontotemporal Dementia
Study Contact:
(651) 495-6363
ClinicalTrials@HealthPartners.com
A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia (Arise2)
Principal Investigator: Marcel Hungs, MD
Study Sponsor: Balance Therapeutics
Location: HealthPartners Neuroscience Center, HealthPartners Sleep Health Center
Phase of Study: Phase 2
Purpose of Study: The Arise2 clinical research study hopes to find a more effective treatment for those with Idiopathic Hypersomnia (IH). The study will look at the safety and effectiveness of the study drug (BTD-001) on mental fogginess, sleep, functionality, and quality of life in those with IH. Eligible participants will be in the study for between 9 and 14 weeks. During this time, participants will take the study drug for 14 days and will take placebo (no active ingredients) for 14 days. The study includes several overnight visits and at least one daytime clinic visit.
Eligible Diagnosis: Idiopathic Hypersomnia (IH)
Study Contact:
651-496-6363
ClinicalTrials@HealthPartners.com
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson’s Disease (PD)
Principal Investigator: Julia C. Johnson, MD
Study Sponsor: AbbVie
Location: HealthPartners Neuroscience Center
Phase of Study: Phase 3
Purpose of Study: The purpose of this study is to test whether ABBV-951 (study drug) is safe in patients with Parkinson’s disease while administered through a 24-hour pump. The study is also seeking to find out how well ABBV-951 works to control Parkinson’s disease symptoms. Eligible participants will receive study drug for up to 52 weeks and visit the study center at least 13 times over the duration of the study.
Eligible Diagnosis: Parkinson’s Disease
Study Contact:
651-496-6363
ClinicalTrials@HealthPartners.com
Brain Iron Imaging in Parkinson’s Disease
Principal Investigator: Julia Johnson, MD
Study Sponsor: RedFund
Location: HealthPartners Neuroscience Center
Purpose of the Study: In this explorative study we will use Quantitative susceptibility mapping (QSM) to investigate the cerebral iron content in different intracranial regions of interest to answer the question which region has the highest correlation between iron accumulation and cognitive dysfunction in patients with Parkinson’s disease.
Recruitment Status: Recruiting
Study Contact: 651-495-6363
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS (REFALS)
Principal Investigator: Guarav Guliani, MD
Study Sponsor: Orion Corporation, Orion Pharma
Location: HealthPartners Neuroscience Center
Phase of Study: Phase 3
Purpose of Study: This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group, multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2 mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS).
This study is no longer enrolling new subjects.
Eligible Diagnosis: Amyotrophic Lateral Sclerosis (ALS)
Study Contact:
651-496-6363
ClinicalTrials@HealthPartners.com
Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension (REFALS-ES)
Principal Investigator: Guarav Guliani, MD
Study Sponsor: Orion Corporation, Orion Pharma
Location: HealthPartners Neuroscience Center
Phase of Study: Phase 3
Purpose of Study: This study provides an opportunity for subjects in the REFALS study to continue treatment with oral levosimendan. The study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with ALS. This is an open-label study, so that all eligible subjects that complete the double-blind REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. The primary objective, in addition to continuing treatment for subjects enrolled in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients. Another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with ALS. This study is open only to patients taking part in the REFALS study.
Eligible Diagnosis: Amyotrophic Lateral Sclerosis (ALS)
Study Contact:
(651) 496-6363
ClinicalTrials@HealthPartners.com
Genentech: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of MTAU9937A in Patients with Moderate Alzheimer’s Disease
Principal Investigator: Michael Rosenbloom, MD
Study Sponsor: Genentech, Inc.
Phase of Study: Phase 2
Location: HealthPartners Center for Memory and Aging, HealthPartners Institute
Purpose of Study: This study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of MTAU9937A in patients with moderate Alzheimer’s disease, ages 50-85. Study drug administration will occur every 2 weeks for the first three doses of the double‑blind treatment period and every 4 weeks thereafter for approximately a year altogether. During this time, individuals will periodically complete cognitive assessments and lab draws to assess safety, efficacy, and clinical outcomes.
Recruitment Status: Active, Not Recruiting
Study Contact:
(651) 495 – 6363
ClinicalTrials@HealthPartners.com
Lavender vs Zolpidem: Sleep Quality during Diagnostic Polysomnography
Principal Investigator: Charlene McEvoy, MD, MPH
Study Sponsor: RedFund
Location: Regions Hospital Sleep Center, Maplewood, HealthPartners Neuroscience Center
Purpose of the Study: It is a pragmatic clinical study by recruiting patients who are scheduled for their first in center diagnostic or split night sleep study (PSG). The overall goal for this study is to show that lavender is as effective as Zolpidem (non-inferiority analysis) with regard to improvement of sleep quality and usability of diagnostic PSGs with sleep efficiency as the primary outcome.
Recruitment Status: Recruiting
Study Contact: 651-495-6363
Radicava®/(Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
Principal Investigator: Guarav Guliani, MD
Study Sponsor: Mitsubishi Tanabe Pharma America, Inc.
Location: HealthPartners Neuroscience Center
Phase of Study: Phase 4
Purpose of Study: Radicava® (edarvone) is a new drug approved by the FDA as a treatment for ALS in May of 2017. Edaravone has been shown to slow the loss of physical function in ALS. In this research study we want to learn what changes happen in patients with Amyotrophic Lateral Sclerosis (ALS) that can be seen in the blood and urine when they take Edaravone. These changes are called biomarkers. Because ALS is not the same in all people, this study hopes to find biomarkers to show why Edaravone is slowing ALS symptom progression. This is a prospective, observational, longitudinal, multicenter study. Participants, who are scheduled to receive Edaravone and fulfill all eligibility criteria, will be prospectively enrolled by investigators. Up to 300 participants in this study will be followed from enrollment up to 24 weeks after treatment initiation (6 treatment cycles, corresponding to a treatment period of approximately 24 weeks) or premature study discontinuation.
Eligible Diagnosis: Amyotrophic Lateral Sclerosis (ALS)
Study Contact:
(651) 496-6363
ClinicalTrials@HealthPartners.com
Stroke AF: A Prospective, Multi-Site, Randomized, Controlled, Non-Blinded, Post-Market Study
Principal Investigator: Haitham Hussein, MD
Study Sponsor: Medtronic
Location: Regions Hospital and HealthPartners Neuroscience Center
Purpose of Study: To compare the incidence of atrial fibrillation through 12 months between continuous cardiac rhythm monitoring with the Reveal LINQ Insertable Cardiac Monitor and standard-of-care medical treatment in men and women diagnosed with a recent ischemic stroke of presumed known origin. Those who are randomized to the continuous monitoring arm of the study will have a Reveal LINQ Insertable Cardiac Monitor inserted within 10 days of their stroke and undergo continuous remote monitoring. And those who are randomized to the control arm will be followed per site-specific standard of care.
Eligibility: No Longer Recruiting
Study Contact:
(651) 495 – 6363
ClinicalTrials@HealthPartners.com
