Ivanhoe

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 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.

Researchers are evaluating the safety of abdominal vagus nerve stimulation (aVNS) in adults with moderate to severe rheumatoid arthritis (RA) that has not improved with medication. This open-label study focuses on individuals with adult-onset RA who have not responded to biologic or synthetic treatments. The goal is to assess the safety, performance, and potential benefits of the aVNS device over a 24-week period, with long-term monitoring up to 5 years after surgery. Participants will receive an aVNS device implanted by keyhole surgery, which stimulates the abdominal vagus nerve. Stimulation begins two weeks after implantation and is delivered daily for three hours over 22 weeks during the initial study phase. After 24 weeks, those who complete the initial phase may choose to continue using the device, which will remain implanted unless removal is medically necessary or requested by the participant. Follow-up visits occur twice a year for up to five years to monitor safety and device performance. Throughout the study, participants will undergo safety assessments, device checks, and evaluations of RA symptoms at 2, 6, 12, and 24 weeks post-surgery. Researchers will monitor for specific safety events and track device function during the long-term follow-up phase. Total participation time is approximately five years, ensuring comprehensive safety and performance data collection for the aVNS device in this patient group.

Researchers are evaluating the effectiveness and safety of TR987 0.1% gel combined with Standard of Care compared to Standard of Care alone in treating Venous Leg Ulcers (VLUs). This Phase 3, randomized, double-blind, multicenter study includes adults with non-healing VLUs and aims to determine the proportion of participants whose ulcers completely close by the end of 16 weeks of treatment. The study also assesses pain levels, ulcer size changes, and ulcer closure durability at follow-up visits. Participants are randomly assigned to one of two groups: one receiving TR987 0.1% topical gel plus Standard of Care, which includes wound cleansing, dressings, and compression bandaging, and the other receiving Standard of Care alone. Treatment lasts for 16 weeks, with regular assessments to monitor ulcer healing and pain. The study includes safety and supplementary endpoints to further evaluate the interventions. Throughout the study, participants will undergo evaluations of their ulcer status, pain perception, and overall wound healing progress. The main outcome is complete closure of the target ulcer by week 16. Follow-up visits occur to confirm sustained healing. The study measures changes in ulcer area and pain reduction at 12 and 16 weeks. Participants are carefully monitored for safety, with the total study period lasting 16 weeks.