Elk Grove Village

Researchers are evaluating MK-2214, a study treatment designed to slow brain changes in people with early Alzheimers disease AD. AD is a form of dementia that causes memory loss, communication difficulties, and challenges in decision-making, affecting daily tasks. This phase 2 trial aims to determine if MK-2214 slows the spread of tau protein in the brain compared to a placebo, as well as to assess the safety and tolerability of MK-2214. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous IV infusion every 4 weeks during the study. The study uses a parallel design with quadruple masking to compare the effects of the study drug versus placebo over a period of up to approximately 23 months. Both groups receive infusions on the same schedule to maintain the studys integrity. During the study, participants will undergo brain scans including positron emission tomography PET to measure tau protein levels and other assessments such as cognitive and daily living function tests. Researchers will monitor adverse events and treatment discontinuations throughout the study, which lasts up to about 26 months. These assessments help determine the impact of MK-2214 on disease progression and safety in individuals with early AD.

Researchers are conducting an observational registry to collect standardized data from adult patients receiving routine oncology care at participating cancer centers. The study aims to gather detailed information such as baseline patient characteristics, treatments administered, and outcomes to support research and improve clinical trial participation. Patient surveys are also included to enrich the data collected. No treatments or interventions are given as part of this registry. Instead, data is gathered from patients receiving their usual cancer care. This open-ended registry will continuously collect and analyze information over time to better understand treatment patterns, safety, and effectiveness. Participants will provide informed consent and contribute data through their regular care visits and surveys. Researchers will monitor treatment effectiveness mainly by tracking the time until treatment discontinuation. The registry will regularly analyze and present the data collected. Participation may last as long as the patient is receiving treatment and contributing data, with long-term follow-up possible.

Researchers are studying the effects of KarXT combined with KarX-EC to treat cognitive impairment in people with mild to moderate Alzheimers Disease. This Phase 3 clinical trial aims to evaluate both the efficacy and safety of this treatment compared to a placebo, focusing on improving cognitive function and daily living activities over 24 weeks. Participants will be randomly assigned to receive either the active drugs KarXT and KarX-EC or a placebo, following specified dosing schedules. The study uses a double-blind, parallel-group design, meaning neither the participants nor the researchers know who receives the active treatment or placebo during the trial period. Participants will be monitored through various assessments including cognitive scales like the Alzheimers Disease Assessment Scale-Cognitive Subscale 11 ADAS-Cog11 and clinician interviews at baseline and week 24. Safety will be closely observed via monitoring adverse events, vital signs, laboratory tests, and heart function tests. The total duration of participation includes treatment and follow-up until study completion.

Researchers are evaluating the safety and effectiveness of the Edwards SAPIEN X4 and X4S Transcatheter Heart Valves THV in people with symptomatic, severe, calcific aortic stenosis. This is a prospective, single group, multicenter study that also includes a separate registry for participants with bicuspid aortic valve morphology. Participants will undergo transcatheter aortic valve replacement TAVR using the SAPIEN X4 or X4S valves. Those with bicuspid aortic valves will be enrolled in a distinct registry but will also undergo TAVR. The study focuses on implantation of these balloon-expandable heart valves as the main intervention. During the study, participants will be monitored for safety and outcomes like death and stroke over one year. Researchers will assess heart function through the Kansas City Cardiomyopathy Questionnaire and check for complications such as paravalvular leak and the need for a permanent pacemaker within 30 days. The total participation time includes follow-up assessments up to one year after valve implantation.

Researchers are conducting an observational study to create precision external control groups using current and future data from patients with advanced or metastatic non-small cell lung cancer NSCLC. This study aims to evaluate different patient cohorts based on specific genetic mutations, PD-L1 status, and lines of therapy to better understand outcomes in this population. Participants are grouped into various cohorts depending on their treatment stage and genetic profile, including those starting first line therapy with immune checkpoint inhibitors ICI, patients with actionable EGFR or KRAS mutations, and those receiving second or later line therapies. The study collects information on patients receiving treatments such as ICI alone or in combination with chemotherapy, targeted therapies like osimertinib, and other physician-chosen regimens. During the study, participants medical data and treatment responses will be observed without intervention. Researchers will assess objective response rates, progression-free survival, overall survival, and time to next treatment across cohorts from September 2025 to April 2029. Participants will be followed over time to gather this information, with no additional treatments or procedures mandated by the study.

Researchers are evaluating the efficacy and safety of lutetium 177Lu vipivotide tetraxetan AAA617 in adult men with oligometastatic prostate cancer OMPC that is progressing after initial treatment to the primary tumor. The goal is to control tumor recurrence and delay progression to fatal metastatic disease while preserving quality of life by postponing androgen deprivation therapy ADT. This is a Phase III, open-label study sponsored by Novartis Pharmaceuticals. Participants will receive stereotactic body radiation therapy SBRT to all metastatic prostate cancer lesions before starting treatment. Those in the investigational group will then receive up to four cycles of AAA617 every six weeks, with each cycle consisting of a dose of 7.4 GBq 200 mCi administered once. The control group will receive SBRT followed by observation without additional treatment. SBRT procedures last about three weeks, and treatment or observation continues until disease progression. Participants will undergo baseline assessments including PETCT scans with gallium 68Ga gozetotide or piflufolastat 18F, CT or MRI and bone scans. Follow-up visits occur weekly during weeks 1 and 3 of each treatment cycle and every 16 weeks thereafter until disease progression. Researchers will monitor metastasis-free survival, time to hormonal therapy, PSA progression, quality of life, pain, adverse events, and overall survival over approximately 6.5 years of study duration.

Researchers are evaluating whether ataciguat can slow the progression of moderate calcific aortic valve stenosis CAVS in adults aged 50 and older. This study is conducted in two parts Part A focuses on whether ataciguat reduces calcium buildup in the aortic valve over 24 weeks, while Part B examines if the drug slows narrowing of the valve area and improves peak oxygen consumption over 48 weeks. Safety, tolerability, and how the body processes ataciguat are also assessed. Participants receive either ataciguat or a placebo daily for up to 156 weeks. Part A enrolls about 132 participants, and Part B will begin after Part A completes, enrolling around 1144 participants. Part B includes additional evaluation of heart function and ability to exercise. The study uses a randomized, double-blind design, meaning neither participants nor researchers know who receives the drug or placebo. During the study, participants undergo imaging tests like CT scans and echocardiograms to measure valve calcium and valve area. Cardiopulmonary exercise testing CPET is used to assess peak oxygen consumption. Researchers also monitor heart function, symptoms, and quality of life using questionnaires. Assessments occur mainly at baseline, Week 24, and Week 48, with long-term follow-up to 156 weeks for safety and efficacy. The studys total duration extends to 2030.

Researchers are evaluating the Aortix System, a circulatory support device, for patients with acute decompensated heart failure ADHF who have persistent congestion despite standard medical treatment. This study compares the safety and effectiveness of the Aortix device versus usual medical care in patients who are resistant to diuretics, regardless of their hearts ejection fraction. The trial includes a randomized group and an additional registry arm for patients needing improved kidney function before advanced therapies. Participants will be randomized in a 21 ratio to receive either the Aortix device or standard care based on a diuretic treatment algorithm. Those in the registry arm will receive support from the Aortix system. The study will enroll up to 320 patients across multiple sites, with the randomized portion including up to 240 participants and 80 in the registry. Treatment involves device placement and medical management during hospitalization for heart failure. Throughout the study, participants will be closely monitored for safety events and treatment effectiveness over 30 days. Key assessments include fluid loss, survival, heart failure rehospitalizations, kidney function, and patient symptoms such as breathlessness. Follow-up visits and evaluations will occur to track adverse events, biomarker levels, body weight, and other clinical measures to understand how well the device supports heart failure management.

This research evaluates the safety and effectiveness of the GORE4 CARDIOFORM Septal Occluder device in adults who have had an ischemic stroke thought to be caused by a patent foramen ovale PFO, a heart condition. The study aims to assess device performance and the quality of operator training in real-world, post-approval settings. Up to 636 adults aged 18 to 70 will participate across up to 40 U.S. centers. Participants will receive the GORE4 CARDIOFORM Septal Occluder to close the PFO, combined with antiplatelet medical management. The device is commercially available and implanted as a one-time procedure. After implantation, participants will be followed for up to 5 years with scheduled visits at 1 month, 6 months, 12 months, and annually thereafter. Throughout the study, participants will undergo assessments including echocardiographic examinations to evaluate PFO closure and residual shunts, monitoring for new atrial arrhythmias, and tracking serious adverse events related to the device or procedure. The main outcomes include measuring the proportion of participants experiencing recurrent ischemic stroke up to 24 months after implantation and safety events within 30 days. This long-term follow-up allows careful evaluation of device performance and participant health over time.

Researchers are conducting the FLEX Registry, a large-scale, population-based study focusing on patients with stage I to III breast cancer who have undergone MammaPrint and BluePrint testing on their primary breast tumors. This observational registry aims to gather comprehensive full genome expression data linked with clinical information to explore new gene associations that may have prognostic or predictive value. The design is adaptive, allowing additional targeted substudies and arms to be added over time for more specific investigations. All participants will have their tumor samples tested using MammaPrint and BluePrint through the full-genome testing array provided by Agendia. Treatment decisions are made by the treating physician following NCCN guidelines or recognized alternatives, with no specific treatment mandated by the study. The registry plans to enroll about 30,000 patients from more than 125 US institutions, encompassing various treatment arms detailed in study appendices. Participants will have clinical data collected online at multiple time points at enrollment, during treatment, and at 1, 3, 5, and 10 years after diagnosis. This long-term follow-up allows researchers to study gene expression alongside clinical outcomes, supporting the creation of subgroup analyses and future targeted trials. The primary outcomes include establishing a large-scale full genome expression registry and providing infrastructure for examining smaller patient groups over the 10-year study period.