Neurosciences clinical trials

Trials Open to Enrollment and Contact Information

  

Early Memory Loss
 

Study title: CREAD 2: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Crenezumab in Patients with Prodromal to Mild Alzheimer's Disease

Principal Investigator: Michael H. Rosenbloom, MD

Phase of Study: Phase III

Location: HealthPartners Neuroscience Center

Purpose of Study: To evaluate cremezumab 60 mg/kg compared with placebo when administered by IV infusion every 4 weeks for 100 weeks. It is believed that the accumulation of beta amyloid in the brain is involved in the development of Alzheimer's disease. Targeting of beta amyloid and displacement from the brain may modify disease progression.

Inclusion/Exclusion: Ages 50 to 85 years old, prodromal Alzheimer's disease (pAD), mild cognitive impairment (MCI), probable mild Alzheimer's disease and positive biomarkers. 

Study Contact: 651-495-6363 or ClinicalTrials@HealthPartners.com

 

Study Title: A Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and the Therapeutic Effectiveness of Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease

Principal Investigator: Michael Rosenbloom, MD

Phase of Study: Phase II

Study Sponsor: HealthPartners Center for Memory and Aging, HealthPartners Institute

Location: HealthPartners Neuroscience Center: 295 Phalen Blvd., St. Paul, MN 55130

Purpose of Study: This research study is being done to find out whether a drug called glulisine (study drug), which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes mellitus (type II diabetes), is safe and effective in improving memory and daily function in individuals with amnestic mild cognitive impairment (aMCI) or probable mild Alzheimer's disease (AD) when delivered as nasal spray (intranasally) compared to placebo (no active drug). The study drug or placebo will be administered using a new device called the Pressurized Olfactory Delivery (POD) Nasal Device. The study will include 90 participants who will receive instruction on how to use this device to administer the study drug or placebo twice daily. Participation in the study can last up to 8 months, with 11 study visits during that time. The use of flulisine (study drug) in the treatment of memory and daily function in amnestic mild cognitive impairment (aMCI) and Alzheimer's disease (AD) is experimental and has not been approved by the U.S. Food and Drug Administration (FDA) for this condition.

Eligible Diagnosis: Amnestic mild cognitive impairment (aMCI), probable mild Alzheimer's disease

Study Contact: 651-495-6363 or ClinicalTrials@HealthPartners.com

 

Down Syndrome

 

Study Title: A Double-Blind, Placebo-Controlled, Cross-Over Pilot Investigation of the Safety of Intranasal Glulisine in Down Syndrome

Principal Investigator: Michael Rosenbloom, MD

Phase of Study: Phase 1

Study Sponsor: HealthPartners Center for Memory and Aging

Location: HealthPartners Neuroscience Center, 295 Phalen Blvd., St. Paul, MN 55130

Purpose of Study: This study is a single-center, randomized, double-blind, placebo-controlled, cross-over pilot study designed to assess the safety of intranasally delivered glulisine versus placebo in patients with Down syndrome. Subjects will be randomized into this cross-over study and subject comparisons conducted between single treatment of intranasal glulisine and single treatment of intranasal placebo. All subjects will also receive a single treatment of placebo prior to randomization to ensure adherence to study procedures.

Eligible Diagnoses: Down syndrome

Study Contact: 651-495-6363 or ClinicalTrials@HealthPartners.com

 

Limited Enrollment for Patients Treated at Regions Hospital

 

Study Title: RESPECT-ESUS: A Randomized, double-blind Evaluation in secondary Stroke Prevention comparing the Efficacy and safety of the orgal Thrombin inhibitor dabigatran etexilate (110 mg or 150 mg, oral, twice daily) versus acetylsalicylic acid (100 mg, oral, once daily) in patients with Embolic Stroke of Undetermined Source

Principal Investigator: Haitham Hussein, MD

Phase of Study: Phase 3

Study Sponsor: Boehringer Ingelheim

Location: HealthPartners Neuroscience Center

Purpose of Study: To evaluate the effectiveness and safety of dabigatran etexilate compared to aspirin for the prevention of stroke recurrence in men and women diagnosed with an embolic stroke of undetermined source within the last three to six months.

Eligibility: A diagnosis of embolic stroke of undetermined source within the last three to six months. Age 60 or older, or age 18-59 plus one of the following: Mild to moderate heart failure, diabetes mellitus, hypertension, patent foramen ovale or a history of having a prior stroke.

Study Contact: Jennifer Daily, 651-495-6368 or Jennifer.J.Daly@HealthPartners.com

 

Study Title: 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: Having an ischemic stroke believed to be due to small-vessel disease, large-vessel cervical or intracranial atherosclerosis within the past 10 days. Being willing and able to undergo study requirements and expected to be geographically stable during study follow-up. Age 60 years and older, or age 50 to 59 years plus a documented medical history of at least one of the following: Congestive heart failure, hypertension, diabetes mellitus, vascular disease, or a prior stroke occurrence greater than 90 days in the past.

Study Contact: Jennifer Daly, 651-495-6368 or Jennifer.J.Daly@HealthPartners.com 

 

Active Trials in Follow-Up Only

 

A Phase III, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Clinical Trial to Study the Efficacy and Safety of MK-8931 (SCH 900931) in Subjects with Amnesic Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal AD).

An Open-Label Extension Study to Evaluate the Long-Term safety and Tolerability of Lu AE58054 as Adjunctive Treatment to Donepezil in Patients with Mild-Moderate Alzheimer's disease.

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Efficacy and Safety Trial of MK-8931 with a Long-Term Double-Blind Extension in Subjects with Mild to Moderate Alzheimer's Disease