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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 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 investigating new vaccines to protect against illnesses caused by Streptococcus pneumoniae bacteria, which has many different types called serotypes. Vaccines include small parts of certain serotypes that do not cause infection but help the body develop antibodies to fight the bacteria. This study focuses on a new vaccine called V118E and aims to assess its safety and how well healthy adults tolerate it. Participants will receive injections through the muscle (intramuscular administration) of either the V118E vaccine, the PREVNAR 20™ vaccine, or a saline solution. The study is randomized and double-blind, meaning neither participants nor researchers know which treatment is given, to fairly evaluate safety and immune response. This is a Phase 1 trial involving healthy adults aged 18 to 49 years. During the study, researchers will monitor participants for various side effects including injection-site and systemic reactions up to 7 days after vaccination, immediate reactions within 30 minutes, and other adverse events for up to 28 days. Serious or medically attended adverse events and events of special interest will be followed for up to 12 months after the final vaccination. The study aims to gather detailed safety and tolerability data over this period.

Researchers are evaluating the long-term safety and tolerability of KarXT in treating mania or mania with mixed features in adults with Bipolar-I disorder. This phase 3, open-label extension study aims to better understand how KarXT performs over an extended period in this population. The study includes participants who either completed previous double-blind placebo-controlled studies or are newly diagnosed with Bipolar-I disorder experiencing manic symptoms. Participants receive KarXT at specified doses on certain days, with some also taking therapeutic doses of Lithium, Valproate, or Lamotrigine as part of their treatment. The study does not mention a placebo group during this extension, focusing instead on monitoring the long-term effects of KarXT alone or in combination with these established therapies. During the study, participants are monitored for adverse events up to week 54 to assess safety. Evaluations include psychiatric assessments using scales such as the Young Mania Rating Scale and CGI-BP score at screening and baseline. Researchers will track treatment-emergent adverse events and overall tolerability throughout the study duration, which lasts up to 54 weeks for each participant.

Researchers are studying sleep patterns in adults with Major Depressive Disorder (MDD) who experience moderate to severe insomnia symptoms (MDDIS) or no to mild insomnia symptoms (non-MDDIS). The goal is to evaluate brain activity during sleep using an at-home sleep Electroencephalogram (EEG) device and to understand how these objective sleep measurements relate to participants' own sleep experiences. Participants will use a sleep EEG device at home to record brain activity during sleep over a specified period. Alongside this, subjective sleep data will be collected using various self-report tools including sleep diaries and standardized questionnaires like the Structured Interview Guide for the Hamilton Depression Rating Scale and Patient-Reported Outcomes Measurement Information System forms. During the study, participants will be assessed both objectively through the EEG recordings and subjectively through questionnaires and interviews about their sleep quality and disturbances. The researchers will analyze these data to characterize sleep features in participants with different levels of insomnia symptoms, monitoring safety and compliance throughout the study period.

Researchers are evaluating the safety and effectiveness of adding KarXT (Xanomeline/Trospium Chloride) to standard treatment for mania in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind study focuses on individuals experiencing acute manic episodes, with or without mixed features, who are already taking lithium, valproate, or lamotrigine. The study aims to measure changes in mania symptoms using the Young Mania Rating Scale at Week 5. Participants will be randomly assigned to receive either KarXT or a placebo alongside their stable dose of lithium, valproate, or lamotrigine. The doses of these medications are specified and given on set days during the study. Only those with stable mood stabilizer doses for at least two weeks prior to screening, and valproate treatment for at least seven months, are eligible. The treatment period lasts for 5 weeks. During the study, participants will be closely monitored through psychiatric evaluations and clinical assessments. Researchers will assess mania severity, safety, and any side effects. The main outcome is the change from baseline in the Young Mania Rating Scale score at Week 5. Participants’ physical health, including liver function and risk of urinary or gastrointestinal issues, will also be monitored to ensure safety throughout the trial.

Researchers are evaluating the effectiveness and safety of KarXT combined with KarX-EC for treating cognitive impairment in people with mild to moderate Alzheimer's Disease. This Phase 3 study focuses on individuals aged 60 to 85 who have a confirmed diagnosis of Alzheimer's disease according to updated clinical criteria and have specific cognitive scores indicating mild to moderate dementia. Participants will receive either the study drugs KarXT and KarX-EC or a placebo, each given at specified doses on certain days. The study is randomized, double-blind, and placebo-controlled to compare the effects of these treatments on cognitive function. Those already taking certain Alzheimer's medications must have stable doses before and during the study. During the study, participants and their caregivers will attend multiple visits where cognitive assessments and interviews will be performed. Key measures include changes in a cognitive scale (ADAS-Cog11) and clinical impressions of improvement at 24 weeks. Caregivers play an important role by providing information, ensuring medication adherence, and participating in study activities. Safety and treatment effects will be carefully monitored throughout the trial.

This research aims to evaluate how well and how safely rimegepant works when taken during the peri-menstrual period to prevent menstrual migraine attacks in women with this condition. The study focuses on women aged 18 to 45 who have a history of menstrual migraines and regular menstrual cycles. It is a Phase 3 clinical trial comparing rimegepant to a placebo. Participants will receive either rimegepant 75 mg oral disintegrating tablets or matching placebo tablets for 7 days during the peri-menstrual period. In addition, they may use rimegepant or standard care medications as needed for acute migraine treatment. The study is double-blind and parallel group, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment phase. During the study, researchers will monitor the average change from baseline in the number of migraine days occurring per 5-day peri-menstrual period over five menstrual cycles. Participants will be assessed regularly to track migraine frequency, safety, and medication use. The total study duration covers multiple menstrual cycles to observe effects over time and ensure participant safety.

Researchers are evaluating whether the medicine vicadrostat, combined with empagliflozin, helps adults with chronic heart failure (HF) who have a weakened heart pumping function, specifically a left ventricular ejection fraction (LVEF) below 40%. Eligible participants must have been diagnosed with chronic HF at least 3 months before joining. The study is a Phase III trial designed to compare the effects of vicadrostat plus empagliflozin against placebo plus empagliflozin in people with symptomatic chronic HF classified as New York Heart Association classes II to IV. Participants are randomly assigned to one of two groups. One group takes tablets containing vicadrostat and empagliflozin, while the other group takes placebo tablets that look like vicadrostat along with empagliflozin. Tablets are taken once daily for a period ranging from about 6 months up to about 3.5 years. Participants continue their usual heart failure treatments during the study. The study is double-blind, meaning neither the participants nor the study staff know who is receiving which treatment. During the study, participants regularly visit the study site or may have phone contacts for follow-up. They answer questions about their health and well-being. Doctors monitor and record any worsening of heart failure symptoms, hospital visits due to heart failure, or deaths. They also check participants' overall health and note any side effects. The main outcome measured is the time until a participant experiences cardiovascular death, hospitalization for heart failure, or an urgent heart failure visit, over up to 43 months of follow-up.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.