Elk Grove Village

Researchers are studying a treatment called MK-2214 to see if it can slow certain brain changes in people with early Alzheimer's disease (AD). AD is a form of dementia that causes memory loss, difficulties with communication, and challenges in decision-making, which affect daily activities. The study aims to find out if MK-2214 can slow the spread of tau protein in the brain compared to a placebo and to assess the safety and tolerability of MK-2214. Participants will receive either MK-2214 or a placebo through an intravenous (IV) infusion. The study is designed as a phase 2, randomized, placebo-controlled, double-blind trial with parallel groups. The treatment period lasts up to about 23 months, during which participants will receive infusions as scheduled. The placebo looks like the study treatment but contains no active drug, helping researchers understand the treatment's effects. Throughout the study, participants will be monitored for changes in tau protein levels in the brain using PET scans and for any adverse events or side effects. Researchers will track the number of participants experiencing adverse events and those who stop treatment because of them, with safety follow-up lasting up to approximately 26 months. Participants will also undergo brain imaging such as CT, PET, or MRI scans. The study involves regular assessments to measure the treatment's impact and ensure participant safety over the study duration.

This research aims to collect detailed and standardized data from adult patients receiving routine cancer care at participating oncology centers. The study is observational and focuses on gathering information about patients, their treatments, and outcomes to support research and development in oncology. Patient surveys are also part of the data collection process to enrich the information gathered. Since this is an observational registry, there are no specific treatments or interventions provided by the study. Instead, it collects data on standard care treatments administered at the participating centers. The registry includes baseline patient information, treatment patterns, safety data, and treatment effectiveness over time. Participants will provide informed consent and contribute data through regular surveys and medical records. Researchers will monitor treatment effectiveness by tracking the time until treatment discontinuation. The study collects and analyzes data continuously, aiming to facilitate more patient involvement in clinical trials and improve cancer care research. Eligible adults may participate for as long as they continue routine care at the centers.

Researchers are evaluating patients with advanced or metastatic non-small cell lung cancer (NSCLC) to create control arms using current and future treatment information. This prospective study aims to generate precise external controls for patients receiving therapies recommended by the National Comprehensive Cancer Network (NCCN). The focus is on patients treated in second or third line with NCCN-approved systemic therapies. Participants must have pathologically confirmed NSCLC and an Eastern Cooperative Oncology Group (ECOG) performance status greater than 1, indicating they are fit for further systemic therapy. Eligible patients are those starting or within 14 days of starting second line therapy according to NCCN guidelines. The study monitors patients over time to assess treatment responses and outcomes. During the study, researchers assess the objective response rate (ORR) by patient cohort from September 2025 to April 2029. Participants are followed closely with imaging and clinical evaluations to ensure compliance with study protocols. Safety and life expectancy of more than three months are considered to support ongoing participation and data collection.

Researchers are investigating the effectiveness and safety of KarXT combined with KarX-EC in treating cognitive problems associated with mild to moderate Alzheimer's Disease. This phase 3 study focuses on patients diagnosed according to the National Institute on Aging and Alzheimer's Association criteria, targeting those with specific dementia stages and confirmed disease pathology. The goal is to assess whether this combination therapy can improve cognitive function in this population. Participants will receive either KarXT and KarX-EC together or a placebo, with doses given on specified days during the study. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active treatment or placebo during the trial. The treatment period lasts up to 24 weeks to evaluate the effects of these medications on cognitive impairment. During the study, participants will be closely monitored through cognitive assessments including the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 and the Clinician's Interview-Based Impression with caregiver input, both measured at 24 weeks. Caregivers play an important role by maintaining regular contact, reporting on the participant's condition, and helping with medication adherence. Safety and cognitive function will be regularly evaluated to understand the impact of the treatment over the study period.

Researchers are evaluating the safety and effectiveness of lutetium (177Lu) vipivotide tetraxetan (AAA617) in adult men with oligometastatic prostate cancer (OMPC) that is progressing after initial treatment to the primary tumor. This Phase III study aims to determine if AAA617 can control recurrent tumors and delay the need for androgen deprivation therapy (ADT), while preserving quality of life. The study focuses on early-stage prostate cancer patients with limited metastatic lesions that are positive for prostate-specific membrane antigen (PSMA). All participants will undergo a baseline PET/CT scan using either gallium (68Ga) gozetotide or piflufolastat (18F) to confirm PSMA-positive lesions, along with conventional imaging such as CT/MRI and bone scans. Following randomization, all metastatic lesions will receive stereotactic body radiation therapy (SBRT) over approximately 3 weeks. Participants randomized to the investigational arm will then receive up to 4 cycles of AAA617 treatment, given once every 6 weeks. Those in the observation group will end treatment after SBRT. Visits are scheduled weekly during treatment cycles and every 16 weeks afterward until disease progression, with the overall study lasting about 6.5 years. During the study, participants will have regular assessments including imaging scans, laboratory tests, and clinical evaluations to monitor disease progression and side effects. A blinded independent review committee will measure metastasis-free survival, tracking time from randomization until evidence of distant metastasis or death, for up to 30 months. Safety and quality of life will also be closely monitored throughout the study and follow-up periods.

Researchers are evaluating the effect of ataciguat on slowing the progression of moderate calcific aortic valve stenosis (CAVS) in adults. This study is divided into two parts: Part A focuses on whether ataciguat reduces aortic valve calcium buildup, and Part B investigates whether ataciguat slows loss of aortic valve area and improves peak oxygen consumption. The study also assesses safety, tolerability, and pharmacokinetics of ataciguat in these participants. Participants will receive either ataciguat or a placebo daily for up to 156 weeks. Part A will enroll about 132 adults with moderate CAVS, while Part B will enroll approximately 1144 participants following completion of Part A. The study is randomized, double-blinded, and placebo-controlled, designed to provide detailed information on ataciguat's effects over time. Throughout the study, participants will undergo non-contrast CT scans to measure aortic valve calcium, echocardiograms to assess valve area, and cardiopulmonary exercise testing to evaluate peak oxygen consumption. Safety and tolerability will be monitored continuously. The primary outcomes include changes in aortic valve calcium at 24 weeks, and changes in aortic valve area and peak oxygen consumption at 48 weeks, with long-term participation lasting up to 156 weeks.

This research aims to evaluate the safety and effectiveness of the GORE4 CARDIOFORM Septal Occluder device in adults who have had an ischemic stroke related to a Patent Foramen Ovale (PFO). The study will assess how well operator education and training from prior trials transfer to real-world use after the device has been approved. Up to 636 participants will be enrolled across about 40 U.S. centers. Participants will receive treatment involving closure of the PFO using the GORE4 CARDIOFORM Septal Occluder device combined with antiplatelet medical management. Follow-up visits are scheduled at 1 month, 6 months, 12 months, and then annually for up to 5 years after the implant to monitor safety and effectiveness. The study focuses on reducing recurrent strokes in this patient population. During the study, participants will undergo regular clinical assessments and monitoring for adverse events. Researchers will measure the proportion of subjects who experience recurrent ischemic stroke within 24 months post-implant and the proportion with serious device- or procedure-related adverse events within 30 days. The long-term follow-up through 5 years will provide additional data on safety and stroke recurrence.

Researchers are conducting the FLEX Registry to study patients with stage I to III breast cancer who receive MammaPrint and BluePrint testing on a primary breast tumor. This large-scale, population-based, prospective registry aims to create a comprehensive database of full genome expression linked with clinical data to explore new gene associations that may have prognostic or predictive value. The registry uses an adaptive design, allowing additional targeted substudies and arms to be added over time. The study involves patients from over 125 U.S. institutions, with an anticipated enrollment of around 30,000 participants. Treatment decisions are made by physicians following NCCN-approved regimens or recognized alternatives. MammaPrint and BluePrint tests are performed by Agendia using the full genome testing array. Data collection occurs at enrollment, during treatment, and at follow-up intervals of 1, 3, 5, and 10 years after diagnosis. Participants will have clinical data entered online at specified time points, with the goal of generating hypotheses for targeted subset analyses and further trials based on the genetic data collected. Outcome measures include the creation of a large registry for gene expression and clinical data over 10 years and the development of shared registry infrastructure to study smaller patient groups. This is an observational phase IV study focused on long-term data gathering and analysis.

Researchers are creating a prospective cohort of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has common EGFR mutations. The study focuses on patients diagnosed on or after January 1st, 2024, and aims to collect standardized clinical data at key points: before treatment begins, during treatment, and when treatment ends. About 30% of patients who join before starting osimertinib therapy will have imaging done at regular intervals to monitor their condition. The study involves patients receiving first-line osimertinib treatment for their advanced NSCLC. Although specific interventions are not detailed, the study tracks progression-free survival from when treatment starts until the disease worsens or the patient passes away, with assessments continuing for up to 100 months. This long-term follow-up allows researchers to observe how the cancer progresses in a real-world setting under this treatment. Participants will undergo standardized data collection including imaging and clinical evaluations at baseline, during treatment, and at therapy discontinuation. Researchers will monitor progression-free survival as the primary outcome. Eligibility is based on diagnosis details and treatment history, with exclusion for certain prior therapies and poor performance status. The study includes adults aged 18 years and older and will gather detailed information over an extended period to better understand treatment outcomes in this patient population.

Heart failure with preserved ejection fraction (HFPEF) is a common and serious condition without effective treatment options. Researchers are evaluating whether adding spironolactone, a medication, to standard care can reduce the combined risk of cardiovascular death and hospitalizations for heart failure in patients with HFPEF. This study is a Phase 3 trial including patients from the Swedish Heart Failure Registry and the US, all having symptoms of heart failure, elevated heart-related blood markers, and an ejection fraction of 40% or higher. Participants are randomly assigned to one of two groups: one receiving spironolactone along with usual care, and the other receiving usual care alone without spironolactone. The study is designed as a registry-randomized clinical trial and will continue until 721 cardiovascular death or heart failure hospitalization events occur, with an enrollment period of 7 years and a total study duration of 9 years. Data collection in Sweden uses registry linkages, while data in the US comes from site reports and supplemented call center follow-up. During the study, researchers will monitor participants for hospitalizations due to heart failure or cardiovascular death as the primary outcome. Secondary outcomes include other hospitalizations, side effects, and how well patients follow their treatment plans. Outcomes are tracked through national registries and direct reporting, with the main data locked and analyzed five years after the study begins. Approximately 2000 patients aged 50 to 99 years will be included to achieve the event target needed for study conclusions.