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Researchers are conducting an open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the effectiveness and safety of PET imaging using [18F]PI-2620 for detecting tau protein buildup in people with Alzheimer's disease and control subjects. The study compares PET imaging results during life with brain tissue analysis obtained after death through autopsy, aiming to improve diagnosis of tau-related brain changes. Participants will receive an intravenous injection of the radioligand [18F]PI-2620 at a dose of 185 MBq 20%. The PET imaging will be performed to visualize tau deposits in the brain. This study focuses on assessing the diagnostic accuracy of this imaging method by comparing it to post-mortem histopathology findings. Throughout the study, participants will undergo PET scans and assessments to determine the presence and extent of tau pathology. The primary outcome measure is the ability of visual assessment of [18F]PI-2620 PET images to correctly distinguish tau neurofibrillary pathology associated with Alzheimer's disease, confirmed at autopsy within about one year. Safety and tolerability during imaging procedures will also be monitored, with a total participation period depending on the timing of brain autopsy after death.

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 studying the effects of NEU-411 in men and women aged 40 to 80 years who have early Parkinson's Disease (PD) with increased activity in the LRRK2 pathway, identified through a genetic test. This Phase 2 trial aims to evaluate how well NEU-411 works and its safety in this specific group compared to a placebo. The study involves participants with clinically established or probable PD and focuses on those with LRRK2-driven PD. Participants will be randomly assigned to receive either NEU-411, a brain-penetrant oral drug that inhibits LRRK2 activity, or a matching placebo once daily for 52 weeks. After completing this treatment phase, participants will have a safety follow-up visit within two weeks. Those eligible may join an open-label extension to receive NEU-411 for an additional 26 weeks. During the study, researchers will monitor changes in a digital biomarker score using a Parkinson's Disease app from enrollment through 52 weeks, along with recording any treatment-emergent or serious adverse events until the study ends at 54 weeks. Assessments include genetic testing, clinical evaluations of PD status, safety monitoring, and tracking of side effects to understand the drug's effects and tolerability over time.

Researchers are conducting a Phase 2, multicenter platform study to evaluate the safety and effectiveness of several investigational treatments for adults with moderately to severely active Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. The study focuses on assessing multiple experimental oral or injectable therapies to better understand their effects on these conditions. Participants will receive one of the study drugs, MT-501 or MT-201, as part of this evaluation. The study aims to gather data on how these treatments perform in terms of safety, how the body processes them (pharmacokinetics), and their biological effects (pharmacodynamics). Treatment effects will be measured over a period of up to 13 weeks. During the study, participants will be monitored for any side effects, serious adverse events, and laboratory test changes. Researchers will also assess the participants' clinical remission status and improvements seen through endoscopic evaluations at 12 to 13 weeks. The total involvement duration includes screening and treatment periods, with careful tracking of outcomes and safety throughout.

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 investigating the long-term safety of buntanetap in people with Parkinson's Disease (PD) over a 36-month period. This open-label study includes two groups: one with participants previously involved in buntanetap trials and another with those receiving deep brain stimulation (DBS) treatment. The study focuses on evaluating safety outcomes, including adverse and serious adverse events during treatment. Qualified participants will receive a daily oral dose of 30 mg buntanetap after a screening period lasting up to 42 days. Cohort 1 includes invited participants from prior buntanetap studies, who will stop their standard PD medications 12 hours before baseline and annual visits to ensure an OFF medication state. Cohort 2 includes participants treated with DBS for at least 12 months; they will stop PD medications 12 hours prior to all clinic visits and adjust their DBS settings to baseline the night before these visits. Throughout the study, participants will be assessed by trained clinicians using cognitive and motor evaluations such as MMSE, MoCA, C-SSRS, and MDS-UPDRS. Each participant is assessed by the same clinician during the study. Researchers will monitor treatment safety, adverse events, and emergent side effects for 36 months. Participants must have a support person for study visits, and certain medication and health stability requirements apply. The total participation can last up to three years, including regular clinical visits and assessments.

Researchers are evaluating the safety and effectiveness 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 to better understand how trontinemab affects cognitive decline in this population. Participants have confirmed Alzheimer's disease pathology and meet specific clinical criteria related to memory and cognitive function. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the active drug or placebo. Treatment will be given over a defined period, and participants will be monitored closely throughout. During the study, participants will undergo various assessments including MRI scans, clinical genotyping, and PET imaging or cerebrospinal fluid tests to confirm disease status. Cognitive tests such as the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating are used to track changes. Researchers will measure the change in Clinical Dementia Rating Sum of Boxes from baseline to week 72 to evaluate treatment effects. Safety and tolerability will also be monitored throughout the study duration.

Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term gut conditions that cause symptoms like diarrhea, inflammation, bleeding, and belly pain. This research aims to see how many participants with UC or CD achieve remission, meaning their signs and symptoms disappear, after 14 weeks of treatment with Vedolizumab. This is a Phase 4 study evaluating the use of Vedolizumab in a community setting for moderate to severely active UC or CD. Participants will receive Vedolizumab treatment for about one year. During the first 6 weeks, the medication will be given through an intravenous infusion. After this period, treatment will continue with subcutaneous injections of Vedolizumab for the remaining weeks. If a participant's condition does not improve after 14 weeks, they will stop this treatment and may switch to another therapy. Additional visits are scheduled at 26 weeks and 52 weeks, with a follow-up assessment 18 weeks after the last dose. Throughout the study, participants will visit the clinic multiple times for monitoring. Researchers will assess remission using patient-reported outcome measures at week 14. Other evaluations include clinical checks and safety monitoring during treatment and after finishing the medication. The total study involvement can last over a year, including treatment and follow-up periods.

The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin \[IL\] antagonist, and no other biologic/small molecule (Group A); one IL antagonist and either one Janus kinase inhibitor (JAKi) or one TNFi (other than adalimumab) \[Group B\] (Cohort 1) or one prior tumor necrosis factor inhibitor \[TNFi\] and no other biologic/small molecule (Group C); one TNFi and either 1 JAKi or one IL antagonist (other than UST) (Group D) (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy. The study will enroll approximately 100 participants. Participants will be assigned to one of the two treatment groups in Part A: * Part A, Cohort 1: Vedolizumab + Adalimumab * Part A, Cohort 2: Vedolizumab + Ustekinumab All participants who achieve therapeutic benefit in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug). This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.

Researchers are evaluating the effects of combining vedolizumab intravenous infusions with oral tofacitinib tablets in adults who have moderate to severe ulcerative colitis (UC) and have not responded well to or tolerated up to two previous tumor necrosis factor (TNF) antagonist treatments. This Phase 4, open-label study focuses on the clinical remission achieved with this dual targeted therapy. The study includes about 65 participants and is being conducted at multiple centers in the United States and Canada. All participants will receive vedolizumab 300 mg intravenously together with tofacitinib 10 mg orally for the first 8 weeks. Those who respond to this combined treatment at Week 8 will then continue with vedolizumab alone for an additional 44 weeks. The total study duration for each participant can be up to 76 weeks, including a follow-up period of 26 weeks after the last dose of vedolizumab to monitor safety. During the study, participants will be regularly assessed for clinical response using the complete Mayo score at Week 8. The researchers will also monitor safety and remission status throughout the treatment and follow-up periods. Participants will undergo endoscopic evaluations, clinical exams, and laboratory tests to track their ulcerative colitis activity and response to the therapies.