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
Recruitment paused due to COVID-19
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 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:
651-495-6363
ClinicalTrials@HealthPartners.com
Acupuncture Treatment for Chronic Post-traumatic Headache in Individuals With Mild Traumatic Brain Injury
Principal Investigator: Amanda Herrmann, PhD
Study Sponsor: Minnesota Office of Higher Education
Location: HealthPartners Neuroscience Center
Purpose of Study: The purpose of the study is to determine the effect of a low vs. high dose of acupuncture treatment in individuals with chronic post-traumatic headache (CPTH). A total of 36 people with mild traumatic brain injury suffering from CPTH will be enrolled in this study to receive acupuncture treatment for 5 weeks. Participants will be randomized into two groups: 1) Low Acupuncture group (5 treatments) and 2) High Acupuncture group (10 treatments). It is hypothesized that both treatment groups will have decreased headaches, but that 10 treatments will greater alleviate headaches when compared to 5 treatments.
Inclusion Criteria:
- Ability to provide and provision of signed and dated informed consent form
- Age 18-65
- Diagnosis of mild traumatic brain injury (mTBI) (as defined by the International classification of headache disorders 3rd edition (ICHD-3); a. Either no loss of consciousness, or loss of consciousness of <30 minutes duration, b. Glascow Coma Scale (GCS) ≥ 13, and c. Symptoms and/or signs diagnostic of concussion)
- Diagnosis of mTBI ≥3 months and ≤12 months at the time of study enrollment
- Suffering from chronic post-traumatic headache (CPTH) of any etiology (e.g. tension or migraine), with chronic defined as developed within 7 days after injury and lasting ≥3 months from the time of injury
- Stable medication regimen for ≥1 months and agree to adhere to his or her current medication treatment regimen through study participation
Exclusion Criteria:
- Non-English speaking
- History of acupuncture since diagnosis of mTBI
- History of pre-existing primary headache, defined as more than 12 days of tension-type headache annually and/or more than one migraine attacks per month in the last year
- History of any other serious neurological, psychiatric, chronic pain disorders, or seizures
- History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture
- History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device
- Recent or active substance use disorder
- Women who are currently pregnant, lactating, or planning to become pregnant during the study
- Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators)
- Active participation or past participation ≤3 months in any other interventional study.
- Unwilling to participate in all study related activities
Study Contact:
(651) 495–6363
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:
651-495-6363
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) 495-6363
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
Radicava®/(Edaravone) Findings in Biomarkers From ALS (REFINE-ALS)
Recruitment paused due to COVID-19
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) 495-6363
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
