Beaumont

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.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating a new approach to prevent cardiovascular events in patients at increased risk due to age and conditions like type 2 diabetes, prediabetes, or metabolic syndrome but without known symptomatic cardiovascular disease. The study compares a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy with standard risk factor-based care to see if the former can better reduce cardiovascular events. The Cleerly system uses imaging to visualize and quantify coronary artery disease and guides personalized treatment and education based on this assessment. The trial uses the Cleerly CAD Staging System device, which employs a proprietary algorithm to detect and stage coronary artery disease and generate a risk score to guide treatment decisions. Participants receive either this stage-based care or the usual care based on traditional risk factors. The study is prospective, randomized, and pragmatic, designed to follow patients over an average of 3.5 years to compare cardiovascular event outcomes between these two care approaches. Participants will be monitored through cardiovascular event tracking throughout the study period. Data collected includes imaging results, risk scores, and treatment adherence to evaluate the impact of the care strategies. The primary outcome is the comparison of cardiovascular event risk between the Cleerly stage-based care and risk factor-based care groups. The study also includes ongoing safety monitoring and personalized management by a cardiologist-led team via digital communication devices.

Researchers are evaluating the safety and immune response of a chikungunya virus virus-like particle (CHIKV VLP) vaccine in children aged 1 to under 12 years. This phase 3, global, randomized, double-blind, placebo-controlled study aims to compare the vaccine with a placebo to understand its effects in this young population. The study focuses on measuring the vaccine's ability to produce antibodies and monitoring safety events over an extended follow-up period. Participants will receive either the CHIKV VLP vaccine, which contains virus-like particles adsorbed on aluminum hydroxide adjuvant, or a placebo consisting of formulation buffer. The vaccination occurs on Day 1, followed by monitoring for adverse events up to Day 29 and immune response assessment on Day 22. The study is planned to continue safety monitoring through Day 732 for those who complete the trial. During the study, children will undergo medical history reviews, physical examinations, and regular safety assessments including recording of any adverse events. Researchers will collect blood samples to measure antibody responses on Day 22 and monitor for any serious or medically significant events throughout the trial. Participants are expected to attend all scheduled visits and comply with study procedures over the course of the study period.

Researchers are evaluating the combination of fruquintinib and FOLFIRI as a second-line treatment for participants with metastatic colorectal cancer (mCRC). This open-label, multicenter Phase II study focuses on participants who have previously received FOLFOX and Bevacizumab-based first-line therapy. The study aims to assess the effectiveness and safety of this combination in treating mCRC, especially in those with histologically confirmed adenocarcinoma of the colon or rectum. Participants will receive oral fruquintinib daily for the first 21 days of each 28-day cycle. In addition, FOLFIRI will be administered intravenously every two weeks on day 1 of each 28-day cycle, consisting of irinotecan, leucovorin, and 5-fluorouracil delivered by bolus and continuous infusion. Up to 60 participants will receive this combination treatment and be monitored throughout the study. During the study, participants will be assessed every two cycles (each cycle lasting 28 days) for up to two years or until disease progression or death. Researchers will measure progression-free survival at six months as the primary outcome. Safety and efficacy will be closely monitored through regular evaluations, including physical exams, laboratory tests, and imaging to track tumor response and treatment effects.

Bipolar disorder is a serious and long-lasting mood disorder affecting both adults and children, with up to 1.8% of the pediatric population in the United States affected. Treatment options for depressive episodes in children with bipolar disorder are limited due to fewer studies compared to adults. This research aims to evaluate how cariprazine affects disease symptoms and safety in children and teenagers aged 10 to 17 years who have bipolar I disorder with depressive episodes. Participants in the study will be randomly assigned to one of two groups: one receiving cariprazine and the other receiving a placebo, with about half of the participants in each group. Cariprazine will be given as oral capsules in doses adjusted based on age and weight. At the third week, doses may be increased for those not responding well, while others will continue their current dose. The treatment lasts 6 weeks, followed by a 4-week safety follow-up period. During the study, participants will attend weekly visits to hospitals or clinics for medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure changes in depression scores and monitor for any adverse events or abnormal clinical signs, including vital signs, ECG, and movement disorders. The total study duration includes the treatment and safety follow-up periods, ensuring careful observation of participants' health and response to treatment.

Researchers are evaluating the safety and how the body processes AZD7760 when given as an intravenous infusion. The study includes healthy adults (Phase I) and adults with end-stage kidney disease who are receiving hemodialysis through a central venous catheter (Phase IIa). It aims to understand the occurrence of adverse events and how the drug behaves in these two groups. In Phase I, participants are randomly assigned to receive one of three doses of AZD7760 or a placebo as a single intravenous infusion. This part includes a 28-day screening period, a 3-day dosing period with the infusion given on Day 1, followed by a 12-month follow-up. In Phase IIa, participants receive either AZD7760 or placebo as two intravenous infusions spaced three months apart (Day 1 and Day 91), along with a 28-day screening period and a 12-month follow-up after the last infusion. Participants will be monitored for adverse events, serious adverse events, and special interest events from Day 1 up to 361 days in Phase I and 181 days in Phase IIa. Assessments will include safety laboratory tests, physical exams, and vital signs. Researchers will closely observe participants during follow-up to evaluate safety and gather pharmacokinetic data over the course of one year after dosing.

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 assessing the safety and effectiveness of Pumitamig combined with chemotherapy compared to Nivolumab combined with chemotherapy in adults with untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. This phase 2/3 study focuses on participants with specific tumor characteristics, including PD-L1 status and HER2-negative cancer, aiming to provide new treatment options for this serious condition. Participants receive either Pumitamig along with chemotherapy drugs Folfox or Capox, or Nivolumab combined with chemotherapy, each given at specified doses on set days. The study is randomized and blinded, involving two parts: phase 2 and phase 3, with treatment tailored based on PD-L1 expression levels. During the study, researchers monitor tumor response using RECIST v1.1 criteria, track progression-free survival up to about 33 months, and overall survival up to approximately 47 months after randomization. Assessments include imaging and clinical evaluations to measure treatment effects and safety over the course of participation, which may last up to 2 years or more for certain outcomes.