Ridgewood

Researchers are evaluating MK-2214, a study treatment designed to slow certain brain changes in people with early Alzheimer's disease (AD), a condition that causes memory loss, speech difficulties, and problems with decision-making. 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 treatment's safety and tolerability. Tau is a protein that builds up in AD and damages brain cells, impacting daily functioning. Participants will be randomly assigned to receive either MK-2214 or a placebo through intravenous (IV) infusions every 4 weeks during the study period. The study uses a quadruple-blind design, meaning that participants, care providers, researchers, and those assessing outcomes will not know which treatment is given. This phase 2 trial is planned to last up to approximately 23 months for treatment and assessment. During the study, participants will undergo brain scans including tau PET imaging and assessments of cognitive and daily living abilities at regular intervals. Researchers will monitor changes in tau protein levels, cognitive scores such as the Clinical Dementia Rating-Sum of Boxes (CDR-SB), and safety outcomes including adverse events and treatment discontinuations. The total study duration includes up to about 26 months of follow-up to evaluate safety and effectiveness.

Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are studying the use of ziltivekimab to treat people who have heart failure along with inflammation. The study aims to compare ziltivekimab with a placebo to understand its effects on heart failure and inflammation. This is a Phase 3 study sponsored by Novo Nordisk A/S, focusing on patients with heart failure who have mildly reduced or preserved heart function and systemic inflammation. Participants will receive monthly injections of either ziltivekimab or a placebo, administered under the skin using either a pre-filled syringe or a pen-injector. The study medicine is given once a month for up to 4 years, alongside standard heart failure care. Two groups exist: one receiving the active drug and the other receiving placebo injections, both continuing standard treatments. During the study, participants will attend up to 20 clinic visits and use a study app on their phones to record each injection and complete questionnaires. Researchers will monitor heart failure events such as hospitalizations and urgent visits, cardiovascular deaths, kidney function, inflammation markers, and quality of life measures over up to 48 months. Safety and disease progression will be closely followed throughout the study period.

Researchers are evaluating the safety and effectiveness of efruxifermin (EFX) in people with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH) who have moderate to advanced liver fibrosis (stage 2 or 3). This Phase 3 study will involve about 1,650 participants divided into two groups based on fibrosis stage and will use a randomized, double-blind, placebo-controlled design. Participants will be assigned to receive either 28 mg or 50 mg of efruxifermin or a placebo, all given by weekly subcutaneous injection. The study includes a screening period of up to 12 weeks, a 52-week primary treatment phase, and long-term follow-up that may last up to approximately 240 weeks. Liver biopsies and other assessments will be done at specific times, including weeks 52, 96, and 240, to evaluate liver changes and treatment effects. Throughout the study, participants will undergo various assessments such as liver biopsies, blood tests, FibroScan scans, and questionnaires to monitor liver health, fibrosis progression, and overall safety. Researchers will track outcomes like resolution of NASH/MASH, fibrosis improvement, liver-related events, and survival over the long term. After the last dose, participants will have a follow-up visit about 30 days later to check their condition.

Researchers are evaluating the efficacy and safety of trontinemab in people with early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia caused by Alzheimer's. This Phase III study is designed as a multicenter, randomized, double-blind, placebo-controlled trial to better understand how trontinemab may impact cognitive and functional changes in this population. Participants will be randomly assigned to receive either intravenous (IV) trontinemab or an IV placebo. The treatment period lasts for 72 weeks, during which participants will receive regular infusions. This trial includes detailed monitoring of brain changes using PET scans, cerebrospinal fluid and blood biomarkers, and cognitive assessments. Throughout the study, participants will undergo multiple evaluations including cognitive tests such as the Clinical Dementia Rating Scale and MMSE, brain imaging scans for amyloid and tau, and safety monitoring for adverse events and immune responses. The study will also assess everyday functioning and collect data on biomarkers related to Alzheimer's disease. Participation requires a study partner and involves visits over approximately 72 weeks.

Researchers are evaluating the safety and effectiveness of two different drug combinations for people with relapsed or refractory multiple myeloma (RRMM) who have had between one and three prior treatments and prior exposure to lenalidomide. The trial compares mezigdomide combined with bortezomib and dexamethasone (MeziVd) against pomalidomide combined with bortezomib and dexamethasone (PVd). This phase 3 study aims to understand which treatment better controls the disease and improves patient outcomes. Participants are randomly assigned to receive either the MeziVd or PVd treatment. Each drug is given at specified doses on certain days, though exact schedules are not detailed here. The study is open-label, meaning both participants and researchers know which treatment is being given. The trial includes multiple centers and continues over a period that may last up to about five years. During the study, participants will be closely monitored through various assessments including measurements of disease progression and survival. Researchers will track progression-free survival, overall response, duration of response, and quality of life among other outcomes. Safety is assessed by monitoring adverse events throughout the study. Participation involves regular visits for treatment and evaluations, and the study may last several years depending on individual patient progress and follow-up.

Researchers are investigating the efficacy and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This phase 3, randomized, double-blind, placebo-controlled study aims to assess how well this combination works compared to placebo in improving cognitive function and overall condition in affected adults aged 60 to 85 years. Participants will receive either the active drugs KarXT plus KarX-EC or a placebo following a specified dosing schedule. The study lasts 24 weeks, during which participants will be randomly assigned to one of these two groups. The trial is designed to carefully monitor effects and side effects of the treatments under controlled conditions. Throughout the study, participants and their caregivers will attend regular visits where cognitive tests like the ADAS-Cog11 and CIBIC+ will be conducted to track changes from baseline. Additional assessments include daily living activities, neuropsychiatric symptoms, safety labs, vital signs, ECGs, and adverse event monitoring. Caregivers will help report on participant condition and medication adherence, supporting comprehensive evaluation of the treatment's impact over the 24-week period.

This research aims to evaluate the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in people who have a failing aortic bioprosthetic valve and are considered at high or greater risk for surgery. The study is a prospective, single-arm, multicenter trial focusing on this specific heart condition involving aortic valve insufficiency or stenosis. Participants will receive an implant of the SAPIEN X4 valve through a transcatheter aortic valve replacement (TAVR) procedure. There are two study groups: one for subjects with a failing surgical aortic valve and another for those with a failing transcatheter heart valve. The study involves implanting the balloon-expandable SAPIEN X4 valve to replace the failing bioprosthetic valve. During the study, participants will be closely monitored with assessments including the occurrence of death and stroke over one year, and measures of heart function and quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) functional class at 30 days and one year. The study involves no randomization or masking, and participants will be followed to assess the valve's performance and safety throughout the study duration.

Researchers are evaluating a new atrioventricular interval modulation (AVIM) algorithm designed to be used with a dual-chamber Medtronic Astra/Azure pacemaker in patients with hypertension. This multinational, randomized, double-blind clinical trial aims to assess the safety and effectiveness of this novel AVIM therapy compared to standard pacemaker therapy without AVIM activation. Participants include patients scheduled for or already implanted with the Astra/Azure pacemaker who also have high blood pressure. The study has three phases: a screening phase, a double-blind randomized phase lasting one year, and an unblinded phase lasting two years. Eligible patients will have the investigational AVIM software downloaded into their pacemaker and be randomly assigned to either have AVIM therapy turned on or off, while continuing their stable antihypertensive drug treatment. The trial compares AVIM therapy activated versus deactivated alongside ongoing medication to evaluate its impact on blood pressure. Participants will be monitored for changes in their average 24-hour ambulatory systolic blood pressure three months after randomization as the primary outcome. Safety is also assessed by tracking serious unanticipated device effects within the same timeframe. The study involves regular assessments during the randomized and unblinded phases, with continued observation for up to three years. All participants maintain their prescribed antihypertensive medications throughout the study.

Researchers are evaluating how to best recommend chemotherapy for patients with colon cancer based on the presence or absence of circulating tumor DNA (ctDNA) after surgery. This Phase II/III trial focuses on patients with Stage IIB, IIC, or Stage III colon adenocarcinoma who have undergone tumor removal. The study aims to use ctDNA status to better predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy. Participants will be assigned to different treatment groups based on their ctDNA status after surgery. Patients without detectable ctDNA will undergo serial ctDNA monitoring without immediate treatment or receive standard chemotherapy regimens such as mFOLFOX6 or CAPOX for varying durations. Patients with detectable ctDNA will receive either standard chemotherapy or intensified regimens like mFOLFIRINOX. Treatments involve intravenous and oral chemotherapy drugs given over several cycles spanning weeks to months. Throughout the study, participants will have ctDNA testing using the Signatera test and be monitored for disease-free survival, overall survival, and recurrence up to five years after randomization. Safety and treatment adherence will also be tracked. Regular imaging and laboratory tests will assess disease status and organ function. The study may include re-randomization for patients who develop positive ctDNA during monitoring. Total involvement may last several years with follow-up for long-term outcomes.