Tel Aviv Yafo

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

Researchers are evaluating the safety and effects of a study medicine called PF-07799933 in people aged 16 years and older who have advanced solid tumors with specific BRAF gene alterations. The study focuses on participants whose cancers have progressed after prior treatments and for whom no satisfactory alternative options remain. The trial is a phase 1, open-label study aiming to assess PF-07799933 alone and in combination with other study medicines. Participants will receive PF-07799933 tablets twice daily. Depending on the study part and tumor type, participants may also receive binimetinib tablets twice daily, or cetuximab injections weekly or every two weeks. Some participants with colorectal cancer may additionally receive a chemotherapy regimen called mFOLFOX6. Treatment duration may last about two years, with close monitoring during regular clinic visits. Throughout the study, participants will have their safety evaluated by tracking dose-limiting toxicities, adverse events, laboratory and vital sign changes, and physical exams. Researchers will also monitor treatment responses and pharmacokinetics of PF-07799933. Dose adjustments or interruptions may occur due to side effects. The study includes ongoing assessments during and up to 28 days after treatment, with overall participation lasting up to two years or more.

This research focuses on people with psychosis linked to Alzheimers Disease who have completed earlier studies CN012-0026, CN012-0027, or CN012-0056. It is a Phase 3 global, multicenter, open-label extension study lasting 52 weeks that aims to evaluate the long-term safety and tolerability of KarXT in this population. Participants will receive KarXT capsules containing Xanomeline and Trospium Chloride. The study includes various dosing levels ranging from 202 mg to 66.76.67 mg taken three times daily. This open-label extension follows completion of previous studies and continues for up to 54 weeks from the initial dose, including a 14-day safety follow-up after the final dose. During the study, participants will be monitored for treatment-emergent adverse events and serious adverse events. Safety assessments include clinical evaluations throughout the treatment and 14 days after the last dose. The total participation time is approximately one year, allowing researchers to understand long-term effects of KarXT in this group.