Naples

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 investigating whether buntanetap/Posiphen can help treat early Alzheimer's disease in adults aged 55 to 85 years. This Phase 3 study aims to find out if buntanetap/Posiphen improves thinking abilities and daily functioning compared to a placebo. It also evaluates the safety of buntanetap/Posiphen by monitoring any medical issues that participants may experience during the trial. Participants will take either a 30 mg capsule of buntanetap/Posiphen or a placebo capsule by mouth once daily for 18 months. The study includes regular clinic visits at screening, enrollment, and months 1, 3, 6, 9, 12, 15, and 18. During some visits, participants will have brain MRI scans. The study uses a double-blind design, meaning neither participants nor researchers know who receives the active drug or placebo. Throughout the study, participants will complete tests and questionnaires to measure cognitive function and daily living activities, including the ADAS-Cog13 and ADCS-iADL scales. Phone calls before and after visits help track progress and adherence. Safety is closely monitored with ongoing assessments from screening through the 18-month treatment period.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating the effects of pelacarsen (TQJ230), given as a monthly injection under the skin, in people with mild to moderate calcific aortic valve stenosis. This study aims to see if pelacarsen can safely slow the progression of this heart valve condition compared to a placebo. The trial is a phase 2, randomized, double-blind, placebo-controlled study conducted at multiple centers. Participants will receive either pelacarsen 80 mg or a matching placebo once a month. Before starting the treatment, they must have elevated lipoprotein(a) levels and be optimally treated for existing cardiovascular risk factors. The study focuses on those aged 50 to under 80 years with mild or moderate calcific aortic valve stenosis. During the 36 months of participation, researchers will monitor changes in peak aortic jet velocity and aortic valve calcium score to assess disease progression. Safety, tolerability, and the impact of the treatment will be evaluated. Participants will undergo regular assessments, including laboratory tests and clinical evaluations, to track heart valve condition and overall health throughout the study.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and possible effectiveness of IM-101 in adults with generalized myasthenia gravis (gMG) who have acetylcholine receptor (AChR) antibodies. The study also explores IM-101’s safety and efficacy in adults with AChR antibody-negative gMG and both types of ocular myasthenia gravis (oMG). This is a Phase 1b/2 trial that investigates different dosages and treatment regimens of IM-101. The trial has two parts. In Part A, participants receive IM-101 or placebo intravenously at a loading dose on Day 1 and Day 15, followed by a maintenance dose on Day 29. In Part B, participants receive IM-101 or placebo intravenously at a loading dose on Day 1 and Day 15, with additional maintenance doses on Days 29, 57, and 85. The study compares multiple ascending doses of IM-101 and placebo to assess safety and efficacy. Participants will be monitored for treatment-emergent adverse events, serious adverse events, and other safety concerns up to approximately 99 days in Part A and up to about 169 days in Part B. Researchers will measure changes in myasthenia gravis symptoms using standardized scores at baseline and Week 16. The study includes various assessments to track participants’ health and how they respond to treatment throughout the trial.

Researchers are studying the effects of zelquistinel, a drug being evaluated for treating major depressive disorder (MDD) in adults aged 18 to 64 years. This Phase 2 clinical trial aims to find out if zelquistinel can reduce depression symptoms compared to a placebo and to assess its safety. Participants diagnosed with MDD and meeting specific severity criteria will be enrolled to better understand the drug's impact on depression scores and potential side effects. Participants will be randomly assigned to receive either zelquistinel or a placebo tablet once a week for six weeks. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug. The trial includes up to 28 days of screening, a 42-day treatment period with weekly clinic visits, and a 4-week follow-up phase. During visits, depression severity is measured using the Hamilton Depression Rating Scale-17 (HDRS-17). Throughout the study, participants will attend weekly clinic visits for depression assessments and monitoring of adverse events. Researchers will track changes in depression scores from baseline to six weeks to evaluate effectiveness. Safety evaluations and follow-up assessments continue for four weeks after treatment. The total participation time may last up to 98 days, including screening, treatment, and follow-up.

Researchers are evaluating the effects of ALN-APP on the progression of cerebral amyloid angiopathy (CAA), a condition affecting blood vessels in the brain. This phase 2 study aims to assess the safety, tolerability, and pharmacodynamics of ALN-APP in adults with sporadic CAA and Dutch-type CAA, a genetic form of the disease. The study includes a 24-month double-blind treatment period followed by an optional 18-month open-label extension to further explore the treatment's effects. Participants receive either ALN-APP or a placebo, both administered directly into the spinal canal (intrathecally). The initial 24-month period is conducted in a double-blind manner where neither the participants nor the researchers know who receives the treatment or placebo. After this, participants may join the open-label extension phase where everyone receives ALN-APP. This design helps to monitor the drug's impact over a long period. During the study, participants will undergo brain scans using magnetic resonance imaging (MRI) to measure new microbleeds in the brain, which are a marker of disease progression. Researchers will also monitor safety and drug effects through various assessments. The total participation time, including screening, treatment, and follow-up, can last up to 50 months, allowing for thorough observation of treatment outcomes and safety.

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 ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the safety of OviTex PRS, a reinforced tissue matrix used in implant-based breast reconstruction surgeries, in women aged 18 to 75 years. This observational study looks at patients who previously received either permanent or resorbable OviTex PRS devices during immediate or two-stage unilateral or bilateral breast reconstructions, placed either above or below the chest muscle. The goal is to understand the safety profile of these devices and help guide future studies on their effectiveness. Participants in the study had undergone breast reconstruction surgery using OviTex PRS combined with implants, either permanent or resorbable types. The procedures included initial surgeries and any necessary exchange surgeries. The study collects data retrospectively and prospectively across multiple centers to assess outcomes related to the use of these devices. During the study, researchers track any significant adverse events within 24 months after implantation of the OviTex PRS device. Participants may be asked to return for follow-up visits, including photographic documentation. The study focuses on monitoring safety outcomes over two years, ensuring patients' recovery and device performance are carefully observed.